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. 2016 Jan 12;2016(1):CD005340. doi: 10.1002/14651858.CD005340.pub4

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