Clinical trials in gynaecological cancer

Lead Research Organisation: MRC Clinical Trials Unit

Abstract

Ovarian cancer is the fourth most common cause of cancer-related death in women. Research at the MRC CTU aims to improve outcomes for women with ovarian cancer, who in spite of a good response to initial treatment, often develop recurrent disease and die. The OV05 trial showed that women treated for recurrence when their CA125 rose did not live longer or have better quality of life than women treated later when they had symptoms or signs of recurrence. |Ovarian cancer treatment includes surgery and chemotherapy. Outcomes (including quality of life) may be improved by giving chemotherapy before and after surgery, making surgery easier with more tumour removed. This is being investigated in the CHORUS trial. |Drugs which block growth factors that ovarian cancer cells need to grow and spread are being tested in randomised trials including bevacizumab (ICON7), erlotinib (Ov07), and cediranib (ICON6). Linked laboratory studies are investigating whether it is possible to predict who will respond to treatments. |It may be possible to improve outcomes in women with newly diagnosed ovarian cancer by giving standard chemotherapy as weekly treatments rather than 3 weekly. This will be investigated in the recently funded ICON8 trial. |

Technical Summary

Epithelial ovarian carcinoma (EOC) is the fourth most common cause of cancer-related death in women and the most lethal gynaecological malignancy. Although it responds well to initial chemotherapy (response rates > 70%) the majority of women (even those who achieve a complete remission) ultimately develop recurrent disease and die. Median progression free survival (PFS) for patients with advanced disease ranges between 16 and 21 months while the median overall survival (OS) lies between 31 and 57 months.||Early treatment of relapse based on the blood biomarker CA125 was evaluated in the OV05 trial. First results, presented at the ASCO in 2009 suggested that starting chemotherapy early based on CA125 alone compared to waiting to start chemotherapy when symptoms occur, does not improve overall survival or quality of life. A manuscript for publication is currently under review.||New treatment strategies based on the fact that ovarian tumours are associated with high expression of angiogenic factors including vascular endothelial growth factor (VEGF) and endothelial growth factor (EGF) have been developed. These factors are targets for newer drugs which block growth factors or their receptors including bevacizumab (ICON7), erltotinib (OV07) and cediranib (ICON6). First results of ICON7 will be presented in 2010. The standard treatment of newly diagnosed ovarian carcinoma includes primary surgery with removal of as much of the tumour as possible (optimal debulking) followed by platinum-based chemotherapy. Some chemotherapy before and after surgery (neoadjuvant chemotherapy) is an alternative treatment strategy being investigated in the CHORUS trial. Optimal debulking may be easier to achieve after 3 cycles of chemotherapy and reduced post operative morbidity could improve quality of life. |Giving standard chemotherapy with carboplatin and paclitaxel as weekly treatments rather than 3 weekly may lead to improved progression free and overall survival in women with newly diagnosed ovarian cancer. This will be investigated in the recently funded ICON8 trial.||ICON3 results, published in 2001 were controversial. OS and PFS were no better in patients treated with platinum based chemotherapy plus paclitaxel than in patients treated with platinum based chemotherapy alone. The ICON3 p53 study investigates the role of the p53 gene in response to platinum. There is evidence to support the hypothesis that patients with wild type p53 have high response rates to single agent carboplatin and may gain no benefit from the addition of paclitaxel chemotherapy. This may explain the result of ICON3 and ICON4. Results will be available in 2011.

Publications

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Bookman MA (2009) Evaluation of new platinum-based treatment regimens in advanced-stage ovarian cancer: a Phase III Trial of the Gynecologic Cancer Intergroup. in Journal of clinical oncology : official journal of the American Society of Clinical Oncology

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Collinson F (2014) Optimal treatment of early-stage ovarian cancer. in Annals of oncology : official journal of the European Society for Medical Oncology

 
Description Citation in Cochrane Review: Angiogenesis inhibitors for the treatment of ovarian cancer
Geographic Reach Multiple continents/international 
Policy Influence Type Citation in systematic reviews
Impact The reviewers conclude that there is some evidence that the addition of concurrent and maintenance bevacizumab to standard chemotherapy may reduce the risk of disease progression, in women with newly-diagnosed advanced ovarian cancer. However, the relevant trial results (ICON7) have only been presented in abstract form and overall survival data is not yet mature. Further data is likely to be required before a change in policy or practice is effected. A NICE technology appraisal on the topic is planned.
 
Description Citation in Cochrane review (follow-up strategies in ovarian cancer)
Geographic Reach Multiple continents/international 
Policy Influence Type Citation in systematic reviews
Impact This Cochrance review is only recently published. The question of follow-up strategies in ovarian cancer and the implications of the MRC OV05 trial has been much discussed at international and national cancer conferences and in medical journals.
 
Description Citation in Cochrane review: Adjuvant (post-surgery) chemotherapy for early stage epithelial ovarian cancer
Geographic Reach Multiple continents/international 
Policy Influence Type Citation in systematic reviews
 
Guideline Title NICE CTA bevacizumab in Ovarian Cancer
Description Citation in NICE STA for bevacizumab
Geographic Reach National 
Policy Influence Type Citation in clinical guidelines
Impact The (as-yet uncompleted) discussion by NICE of the use of bevacizumab in ovarian cancer (from the results of the MRC ICON7 trial) has raised the challenging public health question of how use of an effective agent at a dose lower than its licensed dosage may alter the balance of benefit and cost for the NHS.
 
Guideline Title Ovarian Cancer: The recognition and initial management of ovarian cancer
Description Citation in NICE clinical guideline
Geographic Reach National 
Policy Influence Type Citation in clinical guidelines
URL http://www.nice.org.uk/CG122
 
Description External Beam Radiotherapy for early endometrial cancer
Geographic Reach Multiple continents/international 
Policy Influence Type Citation in systematic reviews
 
Description Lymphadenectomy for early endometrial cancer
Geographic Reach Multiple continents/international 
Policy Influence Type Citation in systematic reviews
Impact Cochrane review calls into question use of lymphadenectomy in early endometrial cancer. A little too early for this too be included in guidelines at present
 
Description Ovarian Cancer Consensus Conference 2010
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
 
Description CRUK funding (CTAAC - Chorus)
Amount £588,258 (GBP)
Funding ID CRUK/07/009 
Organisation Cancer Research UK 
Sector Charity/Non Profit
Country United Kingdom
Start 04/2007 
End 04/2014
 
Description CRUK funding (CTAAC - ICON6)
Amount £605,306 (GBP)
Funding ID CRUK/07/025 
Organisation Cancer Research UK 
Sector Charity/Non Profit
Country United Kingdom
Start 07/2007 
End 06/2014
 
Description CRUK funding (CTAAC - ICON8B)
Amount £733,982 (GBP)
Organisation Cancer Research UK 
Sector Charity/Non Profit
Country United Kingdom
Start 04/2014 
End 04/2021
 
Description CRUK funding (ICON8 CTAAC)
Amount £830,815 (GBP)
Funding ID CRUK/10/030 
Organisation Cancer Research UK 
Sector Charity/Non Profit
Country United Kingdom
Start 04/2011 
End 03/2017
 
Title CHORUS trial database 
Description Clinical trial database for the CHORUS trial. 
Type Of Material Improvements to research infrastructure 
Provided To Others? No  
Impact None yet - clinical trial in follow-up. Primary analysis & presentation due in 2013. Will then be used for a meta-analysis with EORTC trial data. 
 
Title ICON3 tumour specimens 
Description Tumour samples (blocks and slides) from over 350 patients from the ICON3 trial have been collected centrally in Newcastle. Linked clinical trial data are also available 
Type Of Material Database/Collection of Data/Biological Samples 
Provided To Others? No  
Impact No material has been provided externally yet, although there are plans to do so following the primary analysis of p53 
 
Title ICON7 tumour and sample bank 
Description Tumour specimens, pretreatment blood specimens and serial blood samples on over 700 women randomised in ICON7 
Type Of Material Database/Collection of Data/Biological Samples 
Year Produced 2012 
Provided To Others? Yes  
Impact 7 translational projects have been approved in an open competitive process and all are being carried out in either 2012 (using PFS data) or in 2013, when overall survival data will be available. 
 
Title ICON8 clinical trial database 
Description Clinical trial database for the ICON8 trial. 
Type Of Material Database/Collection of Data/Biological Samples 
Provided To Others? No  
Impact None yet - clinical trial in recruitment. 
 
Title TRICON8 Sample Collection 
Description Participants in the ICON8 trial were invited to consent to a translational research substudy to provide blood, plasma and tumour samples at the same time as consent to the main trial. Participants could consent at one of three levels depending on their preference and hospital site's resources. Sample coordination, storage and preliminary analysis is undertaken by Cambridge University. Researchers will be able to access samples via a formal application process. This sample collection will represent a valuable resource for future translational work in ovarian cancer and will represent one of the largest bio-repositories for this disease area. 
Type Of Material Biological samples 
Provided To Others? No  
Impact No notable impacts as yet. Translational work utilising the samples is being planned. Other research groups will be able to gain access to the samples through a controlled-access process. 
 
Title TRICON8B Sample Collection 
Description Participants in the ICON8B trial will be invited to consent to a translational research substudy to provide blood, plasma and tumour samples at the same time as consent to the main trial. Participants will be invited to consent at one of three levels depending on their preference and hospital site's resources. Sample coordination, storage and preliminary analysis is undertaken by Cambridge University. Dr James Brenton at Cambridge University has secured a CRUK grant for the funding of TRICON8B. Sample collection is planned to commence in q2 of 2016. Researchers will be able to access samples via a formal application process. This sample collection will represent a valuable resource for future translational work in ovarian cancer and will represent one of the largest bio-repositories for this disease area. 
Type Of Material Biological samples 
Provided To Others? No  
Impact No notable impacts as yet. Translational work utilising the samples is being planned. Other research groups will be able to gain access to the samples through a controlled-access process. 
 
Title ICON6 tumour specimen collection & associated clinical data 
Description Specimens from this completed clinical trial in 2nd line ovarian cancer, along with anonymised demographic and outcome data 
Type Of Material Database/Collection of data 
Year Produced 2015 
Provided To Others? Yes  
Impact 1st use of this collection not yet completed 
 
Title ICON7 trial specimen collection and corresponding clinical database 
Description Tumour and blood specimen collection from this ovarian cancer trial, along with anonymised corresponding demographic and clinical outcome data. 
Type Of Material Database/Collection of data 
Year Produced 2010 
Provided To Others? Yes  
Impact Multiple publications, listed as publication outputs 
 
Title ICON8 Trial Database 
Description A secure database with built in checks/validations, as well as functionality for producing reports, has been developed in-house to record all data collected in the trial. 
Type Of Material Database/Collection of data 
Provided To Others? No  
Impact No impact yet. The data will be made available to other researchers via an application process. 
 
Title ICON8B Trial Database 
Description A secure database with built in checks/validations, as well as functionality for producing reports, has been developed in-house to record all data collected in the trial. 
Type Of Material Database/Collection of data 
Provided To Others? No  
Impact No impact yet. The data will be made available to other researchers via an application process. 
 
Description Barts Chemotherapy Response Score Collaboration 
Organisation St Bartholomew's Hospital
Country United Kingdom 
Sector Hospitals 
PI Contribution Organisational input, provision of samples (omental slides) and future corresponding data
Collaborator Contribution Validation of CRS system and funding of this project.
Impact No outputs at present
Start Year 2015
 
Description CHORUS (NCT74802813) 
Organisation Cancer Research UK
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Trial development and coordination of MRC CHORUS trial
Collaborator Contribution Peer review and approval
Impact Completion of accrual to trial. Results presented in main gynaecological cancer session at ASCO annual meeting 2013.
 
Description CHORUS (NCT74802813) 
Organisation National Cancer Research Institute (NCRI)
Department NCRI Gynaecological Oncology CSG
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Trial development and coordination of MRC CHORUS trial
Collaborator Contribution Peer review and approval
Impact Completion of accrual to trial. Results presented in main gynaecological cancer session at ASCO annual meeting 2013.
 
Description CHORUS-EORTC meta-analysis 
Organisation European Organisation for Research and Treatment of Cancer (EORTC)
Department Gynaecological Cancer Group
Country Belgium 
Sector Charity/Non Profit 
PI Contribution Planned individual patient data meta-analysis of patients recruited to the EORTC 55971 trial and MRC CHORUS trial. Aim is to definitively establish the role of neo-adjuvant chemotherapy in the treatment of advanced ovarian cancer.
Collaborator Contribution Access to data from CHORUS trial.
Impact None yet. Analysis is planned for early 2015.
Start Year 2006
 
Description Collaboration with AstraZeneca on cedaranib following ICON6 trial outcome 
Organisation AstraZeneca
Country United Kingdom 
Sector Private 
PI Contribution Sponsored and ran the ICON6 trial after AZ abandoned development of this compound. Now working with them to produce licensing application. Anticipate considerable research support plus drug supply for trials to follow.
Collaborator Contribution Drug supply only until positive outcome of the study was reported. Subsequently, close colloaboration on preparation of regulatory package.
Impact Full study report in development
Start Year 2007
 
Description Gynecologic Cancer InterGroup (GCIG) 
Organisation Gynecologic Cancer InterGroup (GCIG)
Country Canada 
Sector Charity/Non Profit 
PI Contribution The Gynecologic Cancer Intergroup is an international collaboration of clinical trialists, whose aims are to promote and conduct high quality clinical trials in order to improve outcomes for women with gynecologic cancer. The MRC CTU contributes strongly to this collaboration with the majority of our trials being badged as GCIG trials. The contributions of this group include providing a forum for discussion on clinical trial development and prioritisation of research questions, harmonisation of clinical trial operations, participation in international clinical trial recruitment and meta-analyses.
Collaborator Contribution Collaboration in trials and harmonisation of processes and procedures
Impact Completion of recruitment of ICON7 trial from over 300 clinical sites in 11 countries. Publication of results from ICON5 trial, a GCIG collaboration with UK, US, Italy, Australia and New Zealand (pub med 19224846). Recruitment to ICON6 trial (currently open in UK and Canada). Recruitment to ICON8 trial (currently open in Korea and UK). International collaboration on clinical trials as outlined in publication 19720905
 
Description ICON5 - SP 
Organisation Merck
Department Schering Plough
Country United States 
Sector Private 
PI Contribution Trial design: one of the first trials to use multi-arm, multi-stage design. UK and International collaboration (Italy). Academic trial which,if positive would have been used to support use of pegylated doxorubicin combination for first line treatment of ovarian cancer
Collaborator Contribution free pegylated doxurubicin for ICON5
Impact publication: 19224846
 
Description ICON5 Eli Lilly 
Organisation Eli Lilly & Company Ltd
Country United Kingdom 
Sector Private 
PI Contribution Trial design: one of the first trials to use multi-arm, multi-stage design. UK and International collaboration (Italy). Academic trial which,if positive would have been used to support use of gemcitabine combination for first line treatment of ovarian cancer
Collaborator Contribution Free gemcitabine for ICON5
Impact Publication: 19223846
 
Description ICON5-Merck 
Organisation Merck
Country Germany 
Sector Private 
PI Contribution Trial design: one of the first trials to use multi-arm, multi-stage design. UK and International collaboration (Italy). Academic trial which,if positive would have been used to support use of topotecan combination for first line treatment of ovarian cancer
Collaborator Contribution free topotecan for ICON5 patients
Impact publication: 19224846
 
Description ICON5-amgen 
Organisation Amgen Inc
Country United States 
Sector Private 
PI Contribution Trial design: one of the first trials to use multi-arm, multi-stage design. UK and International collaboration (Italy).
Collaborator Contribution Free G-CSF for patients in ICON5
Impact publication 19224846
 
Description ICON6-AZ 
Organisation AstraZeneca
Country United Kingdom 
Sector Private 
PI Contribution Protocol design and production of clinical guidelines for management of patients in the trial. Trial management and co-ordination of international collaboration with 3 academic groups in 4 countries, access to data. Oversight of trial conduct and responsible for statistical analysis.
Collaborator Contribution Cediranib and placebo trial drug provided. Drug distribution and IVRS randomisation funded by AZ.
Impact The trial has completed accrual, having reached its revised target sample size of 470 patients. A pre-planned safety analysis has been conducted and published. PMID: 21878941. Presentations in 2013 following Primary Outcome analysis: Plenary presentation at ESGO 2013, Presidential slot at ECCO/ESMO 2013 and Clinical Trials Showcaes at NCRI conference in 2013. Posters at ESGO and NCRI (2013 also).
Start Year 2007
 
Description ICON6-AZ 
Organisation National Cancer Research Institute (NCRI)
Department NCRI Gynaecological Oncology CSG
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Protocol design and production of clinical guidelines for management of patients in the trial. Trial management and co-ordination of international collaboration with 3 academic groups in 4 countries, access to data. Oversight of trial conduct and responsible for statistical analysis.
Collaborator Contribution Cediranib and placebo trial drug provided. Drug distribution and IVRS randomisation funded by AZ.
Impact The trial has completed accrual, having reached its revised target sample size of 470 patients. A pre-planned safety analysis has been conducted and published. PMID: 21878941. Presentations in 2013 following Primary Outcome analysis: Plenary presentation at ESGO 2013, Presidential slot at ECCO/ESMO 2013 and Clinical Trials Showcaes at NCRI conference in 2013. Posters at ESGO and NCRI (2013 also).
Start Year 2007
 
Description ICON7-roche 
Organisation F. Hoffmann-La Roche AG
Country Global 
Sector Private 
PI Contribution Protocol design, clinical guidelines for management of patients in the trial, international collaboration and coordination with 9 academic groups in 11 countries, access to data. Oversight of trial conduct and responsible for analysis. Work done within Gynae program of trials allowed MRC CTU to develop and lead an international collaboration supported by industry. As a result MRC CTU is leading ICON7, one of only 3 major international trials that will help to define first line treatment for ovarian cancer
Collaborator Contribution Capacity building in CTU for commercial trials, provision of free drug and drug distribution
Impact Collaborations developed with Roche as part of ICON7 led to further academic-industry partnerships in the development of a large breast cancer trial (Beatrice) Support for ICON7 (an international trial of adding bevacizumab to standard chemotherapy for ovarian cancer) includes educational grant to CTU for international coordination, financial support to international groups, support for sites for additional tests and support to run study locally. Includes £500k for collection of laboratory speciments. In addition Roche provide free bevacizumab to approximately 750 patients randomised to research arm. They also pay for data management and trial monitoring. This trial will support the extension of a licence of bevacizumab for the treatment of ovarian cancer and could not be done without this level of pharma company involvement.; Work done within Gynae program of trials allowed MRC CTU to develop and lead an international collaboration supported by industry. As a result MRC CTU is leading ICON7, one of only 3 major international trials that will help to define first line treatment for ovarian cancer First results of PFS presented at European Society of Medical Oncology 2010 Presidential Symposium and International Gynae Cancer Intergroup Plenary. An updated PFS analysis and preliminary OS analysis was presented in the primary Gynaecological Cancer session at the Americal Society of Clinical Oncologists annual meeting in 2011. Final OS results presented at plenary session at ESGO 2013 and presidential slot at ECCO-ESMO 2013. Poster also at ESGO 2013.
 
Description ICON8 trial (NCT10356837) 
Organisation Australia and New Zealand Gynaecological Oncology Group
Country Australia 
Sector Charity/Non Profit 
PI Contribution Trial development and lead group for an important trial of dose fractionated chemotherapy for women with newly diagnosed ovarian cancer
Collaborator Contribution CR UK Peer reviewed and approved ICON8 as well as funding it. The trial is run through the NCRI infrastructure in the UK. The other groups are collaborating partners and GCIG members, activating the trial to run internationally.
Impact Trial opened in the UK in June 2011 and is actively recruiting patients. Trial opened internationally in Korea in October 2012, in Mexico and Ireland in 2013 and in Australia and New Zealand in 2014. An ancillary sample collection study (TRICON8) has been established in collaboration with the University of Cambridge Cancer Research Institute and funded via a CRUK CTAAC grant.
Start Year 2010
 
Description ICON8 trial (NCT10356837) 
Organisation Cancer Research UK
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Trial development and lead group for an important trial of dose fractionated chemotherapy for women with newly diagnosed ovarian cancer
Collaborator Contribution CR UK Peer reviewed and approved ICON8 as well as funding it. The trial is run through the NCRI infrastructure in the UK. The other groups are collaborating partners and GCIG members, activating the trial to run internationally.
Impact Trial opened in the UK in June 2011 and is actively recruiting patients. Trial opened internationally in Korea in October 2012, in Mexico and Ireland in 2013 and in Australia and New Zealand in 2014. An ancillary sample collection study (TRICON8) has been established in collaboration with the University of Cambridge Cancer Research Institute and funded via a CRUK CTAAC grant.
Start Year 2010
 
Description ICON8 trial (NCT10356837) 
Organisation European Society of Gynaecological Oncology (ESGO)
Department European Network of Gynaecological Oncology Trials Groups (ENGOT)
Country Czech Republic 
Sector Charity/Non Profit 
PI Contribution Trial development and lead group for an important trial of dose fractionated chemotherapy for women with newly diagnosed ovarian cancer
Collaborator Contribution CR UK Peer reviewed and approved ICON8 as well as funding it. The trial is run through the NCRI infrastructure in the UK. The other groups are collaborating partners and GCIG members, activating the trial to run internationally.
Impact Trial opened in the UK in June 2011 and is actively recruiting patients. Trial opened internationally in Korea in October 2012, in Mexico and Ireland in 2013 and in Australia and New Zealand in 2014. An ancillary sample collection study (TRICON8) has been established in collaboration with the University of Cambridge Cancer Research Institute and funded via a CRUK CTAAC grant.
Start Year 2010
 
Description ICON8 trial (NCT10356837) 
Organisation Gynecologic Cancer InterGroup (GCIG)
Country Canada 
Sector Charity/Non Profit 
PI Contribution Trial development and lead group for an important trial of dose fractionated chemotherapy for women with newly diagnosed ovarian cancer
Collaborator Contribution CR UK Peer reviewed and approved ICON8 as well as funding it. The trial is run through the NCRI infrastructure in the UK. The other groups are collaborating partners and GCIG members, activating the trial to run internationally.
Impact Trial opened in the UK in June 2011 and is actively recruiting patients. Trial opened internationally in Korea in October 2012, in Mexico and Ireland in 2013 and in Australia and New Zealand in 2014. An ancillary sample collection study (TRICON8) has been established in collaboration with the University of Cambridge Cancer Research Institute and funded via a CRUK CTAAC grant.
Start Year 2010
 
Description ICON8 trial (NCT10356837) 
Organisation Irish Clinical Oncology Research Group (ICORG)
Country Ireland 
Sector Charity/Non Profit 
PI Contribution Trial development and lead group for an important trial of dose fractionated chemotherapy for women with newly diagnosed ovarian cancer
Collaborator Contribution CR UK Peer reviewed and approved ICON8 as well as funding it. The trial is run through the NCRI infrastructure in the UK. The other groups are collaborating partners and GCIG members, activating the trial to run internationally.
Impact Trial opened in the UK in June 2011 and is actively recruiting patients. Trial opened internationally in Korea in October 2012, in Mexico and Ireland in 2013 and in Australia and New Zealand in 2014. An ancillary sample collection study (TRICON8) has been established in collaboration with the University of Cambridge Cancer Research Institute and funded via a CRUK CTAAC grant.
Start Year 2010
 
Description ICON8 trial (NCT10356837) 
Organisation Korean Gynaecological Oncology Group
Country Korea, Republic of 
Sector Charity/Non Profit 
PI Contribution Trial development and lead group for an important trial of dose fractionated chemotherapy for women with newly diagnosed ovarian cancer
Collaborator Contribution CR UK Peer reviewed and approved ICON8 as well as funding it. The trial is run through the NCRI infrastructure in the UK. The other groups are collaborating partners and GCIG members, activating the trial to run internationally.
Impact Trial opened in the UK in June 2011 and is actively recruiting patients. Trial opened internationally in Korea in October 2012, in Mexico and Ireland in 2013 and in Australia and New Zealand in 2014. An ancillary sample collection study (TRICON8) has been established in collaboration with the University of Cambridge Cancer Research Institute and funded via a CRUK CTAAC grant.
Start Year 2010
 
Description ICON8 trial (NCT10356837) 
Organisation National Cancer Research Institute (NCRI)
Department NCRI Gynaecological Oncology CSG
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Trial development and lead group for an important trial of dose fractionated chemotherapy for women with newly diagnosed ovarian cancer
Collaborator Contribution CR UK Peer reviewed and approved ICON8 as well as funding it. The trial is run through the NCRI infrastructure in the UK. The other groups are collaborating partners and GCIG members, activating the trial to run internationally.
Impact Trial opened in the UK in June 2011 and is actively recruiting patients. Trial opened internationally in Korea in October 2012, in Mexico and Ireland in 2013 and in Australia and New Zealand in 2014. An ancillary sample collection study (TRICON8) has been established in collaboration with the University of Cambridge Cancer Research Institute and funded via a CRUK CTAAC grant.
Start Year 2010
 
Description ICON8 trial (NCT10356837) 
Organisation Research Group on Ovarian Cancer and Gynecologic Tumors of Mexico (GICOM)
Country Mexico 
Sector Charity/Non Profit 
PI Contribution Trial development and lead group for an important trial of dose fractionated chemotherapy for women with newly diagnosed ovarian cancer
Collaborator Contribution CR UK Peer reviewed and approved ICON8 as well as funding it. The trial is run through the NCRI infrastructure in the UK. The other groups are collaborating partners and GCIG members, activating the trial to run internationally.
Impact Trial opened in the UK in June 2011 and is actively recruiting patients. Trial opened internationally in Korea in October 2012, in Mexico and Ireland in 2013 and in Australia and New Zealand in 2014. An ancillary sample collection study (TRICON8) has been established in collaboration with the University of Cambridge Cancer Research Institute and funded via a CRUK CTAAC grant.
Start Year 2010
 
Description NCRI Gynae Clinical Studies Group 
Organisation National Cancer Research Institute (NCRI)
Department NCRI Gynaecological Oncology CSG
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution MRC/NCRI collaboration through NCRI Gynae Clinical Studies group has led to development of main first and second line international trials in ovarian cancer (ICON5 and 7 for first line, ICON8 in developement for first line and ICON6 for second line). MRC CTU has had a representative on this group continuously since its inception.
Collaborator Contribution trial design, clinical input, patient recruitment and follow up
Impact MRC/NCRI collaboratation has enabled the UK to have a major influence on the international research agenda. The NCRI Gynae CSG chair is a recent past Chairman of the GCIG, MRC/NCRI had 5 representatives at the most recent quinquennial Ovarian Cancer Consensus Conference (2010) which establishes international best practice standards for clinical research in ovarian cancer, and resulted publication 21543937, recommendations for 1st line therapy in ovarian cancer.
 
Description NCRN 
Organisation National Cancer Research Institute (NCRI)
Department National Cancer Research Network (NCRN)
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution The gynae cancer trials are a collaboration with the National Cancer Research Network (a component of NIHR and funded by the English Department of Health) and corresponding networks in other UK nations and specifically includes all the staff of each of the clincial sites that have participated in the ICON5, ICON6, OV07 and Chorus trials. Each site identified patients potentially suitable for the trial, sought informed consent, treated and followed-up patients within the trial and provided data through completion and return of case record forms.
Collaborator Contribution Enabled recruitment and follow up of patients enrolled in ICON5, 6, 7, 8, ASTEC, Ov05 and Chorus trials
Impact Publications including (19070891 ASTEC radiotherapy, 19070889 ASTEC surgery, 19224846 ICON5) Completion of MRC Ov05/EORTC 55955 trial, presented at ASCO 2009 Plenary session.
 
Description OV07 
Organisation European Organisation for Research and Treatment of Cancer (EORTC)
Country Belgium 
Sector Charity/Non Profit 
PI Contribution Identification, set up and management of UK collaborating sites. As an intergroup trial, MRC collaboration enables the participation of many UK hospitals that would otherwise only be able to collaborate if they were members of the EORTC.
Collaborator Contribution EORTC are main coordinating centre for the OV07 trial (EORTC 55041) and are responsible for the trial database and analysis
Impact completion of accrual to the trial, follow-up continues.
Start Year 2007
 
Description Ov05-EORTC 
Organisation European Organisation for Research and Treatment of Cancer (EORTC)
Country Belgium 
Sector Charity/Non Profit 
PI Contribution Ov05/EORTC 55955: A randomised trial in relapsed ovarian cancer: Early treatment based on CA125 levels alone vs Delayed treatment based on conventional clinical indicators. Initiated, conducted and analysed this ambitious trial over a 12 year period.
Collaborator Contribution Conduct of Ov05/EORTC 55955 recruitment of patients and collaboration
Impact Presentation at ASCO 2009 Plenary and ESMO/ECCO presidential symposium pubmed ID 20888993
 
Description TRICON8 
Organisation Cancer Research UK Cambridge Institute
Department Functional Genomics of Ovarian Cancer Laboratory
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution We will facilitate entry of patients consenting to the ICON8 trial into the associated translational studies.
Collaborator Contribution Collection, handling, storage and preliminary analysis of blood and tissue samples collected on consenting ICON8 patients.
Impact Collaboration established with the Univeristy of Cambridge Cancer Research Institute and succesful funding application for sample collection grant to CTAAC. Sample collection commenced in May 2013.
Start Year 2012
 
Description TRICON8B 
Organisation Cancer Research UK
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution We will facilitate entry of patients consenting to the ICON8B trial into the associated translational studies and keep records of samples collected via the Translational Research CRF.
Collaborator Contribution Collection, handling, storage and preliminary analysis of blood and tissue samples collected from consenting ICON8B patients.
Impact Establishment of a tissue bank linked to the ICON8 trial
Start Year 2016
 
Title CHORUS 
Description The aim of this phase III randomised controlled trial is to determine the impact of the timing of surgery and chemotherapy in patients with advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer, in terms of survival, progression-free survival, and quality of life. It followed a feasibility study to assess the acceptability of the randomisation to clinicians and patients. The trial completed recruitment in August 20010 with 552 women recruited. It is currently in follow-up. Results were presented in the main gynaecological cancer oral session at the American Society of Oncology Annual Meeting 2013. The principle source of funding is a CRUK CTAAC trial grant. More details can be found at: http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=9 " 
Type Management of Diseases and Conditions
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2013
Development Status Closed
Clinical Trial? Yes
UKCRN/ISCTN Identifier ISRCTN74802813
Impact 1. Completion of feasibility study showed that patients can be recruited to ovarian cancer surgery trials in the UK. Lead to surgical trials planning meeting and further trials are in development via the NCRI Gynaecological Cancer Clinical Studies Group. 2. Trial results confirm that delayed surgery is an acceptable standard of care in advanced ovarian cancer. 
URL http://www.controlled-trials.com/ISRCTN74802813
 
Title ICON5 
Description The GOG-182/ICON5 trial investigated whether survival could be improved in advanced ovarian cancer by addition of a third cytotoxic chemotherapy to standard two-agent chemotherapy with carboplatin/paclitaxel. The results of the trial showed that there was no improvement in progression-free or overall survival with the addition of a third chemotherapy agent and that the three-agent regimens were more toxic. Funding for the trial was provided by Cancer Research UK. The trial has been completed and published (ref 19224846 ). 
Type Therapeutic Intervention - Drug
Current Stage Of Development Wide-scale adoption
Year Development Stage Completed 2010
Development Status Closed
Clinical Trial? Yes
Impact The results of the trial showed that there was no improvement in progression-free or overall survival with the addition of a third chemotherapy agent and that the three-agent regimens were more toxic. It therefore reinforced carboplatin plus paclitaxel as the international standard of care (ref: 21543936) , and has impacted on the treatment of women with ovarian cancer at an international level. 
URL http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=726
 
Title ICON6 
Description A randomised trial of AZD2171 in combination with platinum-based chemotherapy in ovarian cancer relapsing more than 6 months following completion of first-line platinum-based treatment. Primary Outcome of Progression free Survival has been analysed and presented at several conferences, paper in production. Funding provided by CTAAC until June 2014, per patinet payments and International group co-ordination costs funded by AstraZeneca as well as providing free drug. 
Type Management of Diseases and Conditions
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2013
Development Status Under active development/distribution
Clinical Trial? Yes
Impact Cediranib given concurrently with platinum-based chemotherapy improves PFS and when continued as maintenance significantly improves both progression-free and overall survival in women with recurrent ovarian cancer. 
URL http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=1757
 
Title ICON7 
Description ICON7 investigated safety and efficacy of adding bevacizumab to standard chemotherapy in women with newly diagnosed ovarian cancer. The results of ICON 7 along with an American trial (GOG 0218) led to the EMA approval of the drug as first-line treatment in combination with carboplatin and paclitaxel for advanced ovarian cancer. 
Type Management of Diseases and Conditions
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2013
Development Status Under active development/distribution
Clinical Trial? Yes
Impact ICON7 has shown that bevacizumab improves progression-free survival in women with ovarian cancer. It was also found that patients at high risk of disease progression benefit the most from bevacizumab with respect to both PFS and OS. The results can be found in the NEJM, 2011, volume 365, pages 2484-96 OS results have been recently presented at two conferences. In the randomised population, bevacizumab in conjunction with carboplatin and paclitaxel did not improve survival by a clinically important magnitude. However, in a pre-specified subgroup of women at high risk of progression, a benefit of 4.8 months in the restricted mean survival time is observed. 
URL http://www.icon7trial.org/
 
Title ICON8 
Description Ovarian cancer is the most lethal gynaecological malignancy in the UK. Most patients respond well to firstline treatment, surgery and chemotherapy, but the majority go on to develop relapsed disease and the 5-year survival rate for patients with advanced disease is only 30%. There is a significant need to develop more effective firstline treatments. Standard firstline chemotherapy is a combination of two drugs: carboplatin and paclitaxel, given once every 3 weeks for 6 cycles. However, giving these agents weekly may be more effective; this is called dose-fractionated chemotherapy. In ICON8 two dose-fractionated chemotherapy regimens are compared with standard carboplatin-paclitaxel. The main outcome measures are whether dose-fractionated chemotherapy extends the time until ovarian cancer relapses (improved progression-free survival) and whether women who receive it live longer (improved overall survival). Secondary outcome measures are comparative toxicity, impact on quality of life and costeffectiveness. Women with newly diagnosed epithelial ovarian, fallopian tube or primary peritoneal cancers are eligible; including those with highrisk early stage (FIGO IC/IIA) or advanced (FIGO IIBIV) cancers. They can enter the trial either following primary surgery or with a plan to undergo delayed primary surgery between the 3rd and 4th cycles of chemotherapy. Women will be randomised to receive either: standard chemotherapy; or carboplatin given 3-weekly with weekly paclitaxel; or both carboplatin and paclitaxel weekly. Treatment duration in all three arms is 18 weeks. The trial is currently recruiting patients (recruitment is on schedule with 866/1485 patients recruited). The 1st stage analysis investigating feasibility and safety has been completed. Principle funding is from Cancer Research UK (CRUK trial no. CRUK/10/030). 
Type Management of Diseases and Conditions
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2013
Development Status Under active development/distribution
Clinical Trial? Yes
Impact 1. Trial opened across all cancer research networks in England and Wales & 3/4 Scottish networks; resulted in excellent recruitment with current recruitment running at >50 patients per month from UK sites, which is higher than any previous ovarian cancer clinical trial. 2. Established a new collaboration with the Univeristy of Cambridge Cancer Research Institute to establish a trial biobank plus successful CRUK CTAAC funding application for sample collection (TRICON8) 3. Established new international collaborations with Korean (KGOG), Mexican (GICOM) and Irish (ICORG) gynecological oncology research groups. Re-established previous collaboration with Australian/New Zealand group (ANZGOG). 
URL http://www.icon8trial.org
 
Title OV05 
Description To investigate the benefit of early chemotherapy for recurrent ovarian cancer based on a raised CA125 (a serum marker) level alone, versus chemotherapy based on conventional clinical indicators. The policies will be compared in terms of overall survival, quality of life and health economics. The trial was presented in the plenary session at the American Society of Clinical Oncology Annual Meeting in 2009 and published in The Lancet in 2010 (pubmed id: 20888993). 
Type Management of Diseases and Conditions
Current Stage Of Development Late clinical evaluation
Development Status Closed
Clinical Trial? Yes
Impact 1. Highly cited publication in The Lancet (Pubmed id: 20888993) 2. Cited in national and international guidelines 3. Change in clinical practice in the UK and internationally 
URL http://www.controlled-trials.com/ISRCTN87786644
 
Title OVO7 
Description To determine whether the administration of erlotonib (EGFR receptor) as maintenance treatment in patients with ovarian cancer shows improvement in PFS compared to dtandard of care. MRC CTU are acting as co-ordnators in the UK for this trial which is run through EORTC (55041). 
Type Management of Diseases and Conditions
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2013
Development Status Under active development/distribution
Clinical Trial? Yes
Impact Results of this randomized phase III study of erlotinib versus observation in patients with no evidence of disease progression after first-line platin-based chemotherapy for ovarian carcinoma were presented in June 2012 at the ASCO conference. Between Oct 2005 and Feb 2008, 835 pts were randomised by 125 institutions from 10 countries. Median follow-up was 51 months. 25% of the patients stopped erlotinib due to side effects (of these 67% due to rash). In the overall study population maintenance erlotinib after first-line treatment in ovarian cancer did not improve progression-free or overall survival. 
URL http://www.ctu.mrc.ac.uk/ov07/about_ov07.asp
 
Description ASCO 2011 press briefing 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Press activity in UK and international newspapers and ASCO online.

Coverage in ASCO newsletter - raised profile of MRC CTU internationally within the Oncology professional community.
Year(s) Of Engagement Activity 2011
 
Description ASCO press conference on womens health 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact ASCO press conference for advances in womens health. Presented results of ASTEC radiotherapy trial

interviews with journals, CI also interviewed, coverage in ASCO newsletter
Year(s) Of Engagement Activity 2007
 
Description ASCO press conference on womens health results of OV05 trial 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Chief investigator presented results to ASCO media prior to presentation at ASCO 2009 plenary session

Coverage of results in New York Times and other news media.
Year(s) Of Engagement Activity 2007,2009
 
Description ESMO 2010 Press briefing 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Press activity in national UK newspapers and ASCO online

requests for access to slides and follow up interviews
Year(s) Of Engagement Activity 2010
 
Description ICON8 - stage Ia/b results ESGO presentation 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dissemination of interim safety results of ongoing trial showing the safety and feasibilty of the new treatment regimens.

Dissemination of interim safety results of ongoing trial; accrual continued to increase following this.
Year(s) Of Engagement Activity 2013
 
Description ICON8 ASCO presentation 2014 - trial in progress 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Poster presentation describing current trial design and plans for changes, allowing discussion with potential international collaborators

Positive feedback received about planned amendment to trial from potential collaborators.
Year(s) Of Engagement Activity 2014
URL http://meetinglibrary.asco.org/content/129128-144
 
Description ICON8 ENGOT Frankfurt 2014 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Trial update presentation
Year(s) Of Engagement Activity 2014
 
Description ICON8 ENGOT Liverpool 2013 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Trial update presentation
Year(s) Of Engagement Activity 2013
 
Description ICON8 ENGOT Madrid 2014 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Trial update presentation
Year(s) Of Engagement Activity 2014
 
Description ICON8 ENGOT Nice 2015 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Trial update presentation
Year(s) Of Engagement Activity 2015
 
Description ICON8 ENGOT Vienna 2012 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Trial Update Presentation
Year(s) Of Engagement Activity 2012
 
Description ICON8 GCIG Chicago 2014 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Trial update presentation
Year(s) Of Engagement Activity 2006,2014
 
Description ICON8 GCIG Chicago 2015 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Trial update presentation
Year(s) Of Engagement Activity 2015
 
Description ICON8 GCIG London 2013 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Trial update presentation
Year(s) Of Engagement Activity 2013
 
Description ICON8 GCIG Melbourne 2014 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Trial update presentation
Year(s) Of Engagement Activity 2014
 
Description ICON8 GCIG Tokyo 2015 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Trial update
Year(s) Of Engagement Activity 2015
 
Description ICON8 Launch Meeting 2012 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Trial Launch Meeting
Year(s) Of Engagement Activity 2012
 
Description ICON8 NCRI presentation of site set up times 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Presentation showed continuing delays in opening sites in UK-led academic clinical trials adding weight to initiatives to accelerate R&D approval times.

Data presentation methods used by others presenting similar data.
Year(s) Of Engagement Activity 2012
URL http://conference.ncri.org.uk/abstracts/2012/abstracts/B144.html
 
Description ICON8 stage Ia/b presentation at NCRI 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Poster presentation of interim safety and feasibility results of an international ovarian cancer trial (ICON8), shared with current and potential future collaborators.

Accrual to the trial continued to increase, has completed accrual slightly ahead of schedule.
Year(s) Of Engagement Activity 2013
URL http://conference.ncri.org.uk/abstracts/2013/abstracts/A69.htm
 
Description ICON8B Feedback Session 2014 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Feedback meeting with patient representatives, research nurses and data managers to gain feedback on ICON8B patient documents, trial protocol and CRFs
Year(s) Of Engagement Activity 2014
 
Description ICON8B Launch Meeting Glasgow 2015 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Trial launch meeting and training presentation
Year(s) Of Engagement Activity 2015
 
Description ICON8B Launch Meeting London 2015 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact ICON8B Trial Launch meeting and training presentation
Year(s) Of Engagement Activity 2015
 
Description NCRI London 2015 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Trial update presentation
Year(s) Of Engagement Activity 2015
 
Description Ovarian CSG Meeting Dec 2015 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Trial Update presentation
Year(s) Of Engagement Activity 2015
 
Description Ovarian Cancer Research at MRC CTU - Meeting with charities 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Type Of Presentation Workshop Facilitator
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact Representatives from ovarian cancer charities and patient advocacy groups attended a meeting at the MRC Clinical Trials Unit to learn more about the ongoing research at the unit, and refine our strategy for dissemination of results.

Strengthening links with charities and advocacy groups.
Year(s) Of Engagement Activity 2011
 
Description Presentation at Ovacome (patient support group) annual meeting 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact Ovacome provides support to women with ovarian cancer and their families and would include past and future patients. Increased engagement of patients with research and understanding of patients needs in trials. Included in Ovacome newsletter

Close contacts with Ovacome maintained. Patients and representatives provide input to information provided on results of MRC CTU gynae cancer trials. Have attracted three patient representatives through these presentations who have become members of our Trial Management Groups for ICON6 and 8.
Year(s) Of Engagement Activity 2007,2011
 
Description Provision of lay summaries of trial results 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Participants in your research and patient groups
Results and Impact Since 2006 it is standard practice to provide written information on trial results to provide to patients at the time that a trial is published or press activity is anticipated.

Patients have access to information about trials, more accurate coverage of trial results on patient support websites e.g. Ovacome after announcement of Ov05 results, ICON7 results
Year(s) Of Engagement Activity 2008,2009,2010
 
Description Public involvement in research workshop 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Type Of Presentation Workshop Facilitator
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact Workshop designed to educate public about research terminology and ways to get involved in clinical research. 19 people attended the workshop, several of whom are now active members of trial management groups.

Increased numbers of lay representatives on trial management groups, including for the ICON6 and 8 trials.
Year(s) Of Engagement Activity 2012
 
Description TRICON8B Launch NCRI Glasgow 2016 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact TRICON8B Launch NCRI Glasgow 2016
Year(s) Of Engagement Activity 2016
 
Description Trial Management Group Meeting- Patient and Public Involvement 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Patients, carers and/or patient groups
Results and Impact A patient representative is invited to attend every ICON8/ICON8B Trial Management Group meeting (held 3 monthly). We have 3 patient representatives that are members of our gynaecological oncology Trial Management Groups.
Year(s) Of Engagement Activity 2014,2015,2016,2017