GOTIC‐001/JGOG‐3019.
Trial name or title | GOTIC‐001/JGOG‐3019 |
Methods | Study duration: projected to take 3 years to complete accrual Type of trial: multicentre RCT Planned follow‐up duration of 3 years |
Participants | Stage: II‐IV newly diagnosed ovarian, fallopian tube and primary peritoneal cancer Residual disease status: Includes women with optimal and sub‐optimal residual disease Performance status: 0‐2 Number to be randomised: 746 Number evaluable: (to be determined) |
Interventions | Arm 1: IV dose‐dense paclitaxel plus IP carboplatin Arm 2: IV dose‐dense paclitaxel plus IV carboplatin IV paclitaxel will be infused on days 1, 8 and 15 at 80 mg/m². Carboplatin at AUC 6 given on day 1, either IP or IV. Repeated every three weeks for six cycles |
Outcomes | PFS, OS, QOL and cost/benefit |
Starting date | June 2010 |
Contact information | fujiwara@saitama‐med.ac.jp |
Notes | The first 120 will be evaluated for the feasibility of the intraperitoneal arm |