MRC Clinical Trials Unit at UCL
90 High Holborn
ICON8 and ICON8B: firstname.lastname@example.org
ICON8B is a randomised (1:1 ratio), two-arm, three-stage Gynaecologic Cancer InterGroup (GCIG) phase III trial designed to evaluate the safety and efficacy of bevacizumab in combination with dose-dense, dose-fractionated carboplatin-paclitaxel chemotherapy compared to standard three weekly chemotherapy and bevacizumab for the first-line treatment of ovarian cancer.
Ovarian cancer is normally treated with surgery and chemotherapy. Surgery aims to remove as much cancer as possible. Chemotherapy destroys or stops the growth of the cancer cells and is normally given once every 3 weeks over 18 weeks. In this study we are investigating the way in which we give chemotherapy to women with ovarian cancer.
Combination chemotherapy with carboplatin and paclitaxel given once every three weeks is an internationally recommended regimen for the first-line treatment of ovarian cancer (standard treatment). Recent studies in ovarian cancer treatment have suggested that giving weekly chemotherapy rather than giving chemotherapy every 3 weeks may give better results. Studies have also suggested that giving bevacizumab (also known as Avastin) with 3 weekly chemotherapy may give better results than giving 3 weekly chemotherapy alone.
Given that the incorporation of bevacizumab and weekly dose-dense paclitaxel into first-line management of ovarian cancer has improved survival in phase III clinical trials, both of these approaches can be considered new standards-of-care. They do however have markedly different economic implications for healthcare providers and place distinct burdens on patients with respect to treatment-related toxicity and duration/intensity of therapy. There is therefore an urgent need to compare these treatment approaches in a randomised trial.
ICON8B is investigating the combination of dose-dense chemotherapy and targeted anti-angiogenic therapy (bevacizumab) in a sub-group of women with high-risk stage III-IV ovarian cancer to see if it is superior to standard three weekly chemotherapy with bevacizumab. High-risk is defined as women with FIGO (2013) stage IIIA1(ii), stage IIIA2 with positive retroperitoneal lymph nodes >1cm in diameter, stage IIIB or IIIC disease with >1cm residual disease following immediate primary surgery (IPS) or those receiving primary chemotherapy with or without delayed primary surgery (DPS), and all stage IV disease.
The ICON8B trial aims to improve treatment outcomes for women with advanced ovarian cancer by comparing two different treatment approaches.
The primary objective of the trial is to investigate whether dose-fractionated chemotherapy with bevacizumab extends the time until ovarian cancer relapses (progression-free survival) and whether women who receive this treatment combination live longer (overall survival) compared to standard three weekly chemotherapy and bevacizumab.
Secondary outcome measures are comparative toxicity, impact on quality of life and cost-effectiveness. Two staged interim analyses are planned: the first looking at the safety of neo-adjuvant bevacizumab in patients undergoing delayed primary surgery and the second looking at our primary outcome measures of progression free and overall survival.
For the most recent version of the study protocol please click here.
No. of Participants to be studied: 660 (estimated accrual time 48 months)
ISRCTN number: ISRCTN10356387
Sponsor: Medical Research Council at UCL
Funding body: Cancer Research UK
Chief Investigator: Andrew Clamp