ICON8 is a randomised three-arm, three stage Gynaecologic Cancer InterGroup (GCIG) phase III trial designed to evaluate the safety and efficacy of dose-dense, dose-fractionated carboplatin-paclitaxel chemotherapy in the treatment of patients 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). There is a growing body of evidence that giving these agents weekly may be more effective (dose-fractionated chemotherapy). In ICON8 two different dose-fractionated regimens are compared with standard chemotherapy: weekly paclitaxel given with standard three-weekly carboplatin; and weekly carboplatin and paclitaxel.
Most patients with ovarian cancer will also undergo surgery as part of their first-line treatment. Patients can be entered into ICON8 either following primary debulking surgery (immediate primary surgery) or with a plan to undergo delayed primary surgery. Patients for whom surgery is not planned are also eligible.
The trial is for patients with either high-risk early stage (FIGO stage IC-IIA clear cell or grade 3 carcinoma) or advanced stage (FIGO stage IIB-IV, all grades and all histological subtypes) epithelial ovarian, fallopian tube or primary peritoneal cancers.
The primary objective of the trial is to investigate whether dose-fractionated chemotherapy extends the time until ovarian cancer relapses (progression-free survival) and whether women who receive it live longer (overall survival) compared to standard chemotherapy. Secondary outcome measures are comparative toxicity, impact on quality of life and cost-effectiveness. Two staged interim analyses are planned: the first looking at feasibility and safety of the dose-fractionated regimens and the second at their activity.
Duration of treatment
The duration of chemotherapy in all arms is expected to be 18 weeks. Treatment delays due to toxicity may extend the treatment duration in all arms. In patients undergoing delayed primary surgery during chemotherapy, the total duration of treatment will vary depending on factors related to surgery, but including the operation and a post-operative recovery period is likely to be between 20-24 weeks.
For a link to the study protocol please click here.
First patient recruited June 2011
1566 patients in total
ISRCTN number: ISRCTN10356387
Sponsor: Medical Research Council
Funding body: Cancer Research UK
Chief Investigator: Andrew Clamp
Co-Chief Investigator: Jonathan Ledermann