An International Phase III Randomised Trial of Dose Fractionated Chemotherapy Compared to Standard Three Weekly Chemotherapy, Following Immediate Primary Surgery or as Part of Delayed Primary Surgery, for Women With Newly Diagnosed Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
ICON8 is a three-arm, three stage trial. Patients will be randomised in a 1:1:1 ratio.
Patients in arm 1 (control arm) will receive weekly carboplatin and paclitaxel on day 1 of a
21-day cycle for 6 cycles. Patients in arm 2 will receive carboplatin on day 1 and
dose-fractionated weekly paclitaxel on day 1, 8 and 15 of a 21-day cycle for 6 cycles.
Patients in arm 3 will receive dose-fractionated weekly carboplatin and dose-fractionated
weekly paclitaxel on day 1, 8 and 15 of a 21-day cycle for 6 cycles.
The trial will have three planned stages. Stage 1 will be conducted to confirm feasibility
and safety of protocol treatment in all patients and separately in the Delayed Primary
Surgery (DPS) patients. The outcome measure for stage 2 will be 9-month progression-free
survival (PFS) rate. The primary outcome measures for stage 3 will be PFS and overall
survival and secondary outcomes will be toxicity, Quality of Life and Health Economics. If
pre-defined levels of deliverability, at stage 1, or activity, at stage 2, are not met then
the research arms will be reconsidered.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Stage 1: Feasibility assessed as the number of cycles and dose intensity of protocol treatment delivered per patient.
6 months after the 50th patient has been randomised to each arm and 6 months after the 50th patient with a plan to undergo delayed primary surgery has been randomised to each arm
United Kingdom: Medicines and Healthcare Products Regulatory Agency