A Randomized Phase II/III Trial of Intravenous (IV) Paclitaxel Weekly Plus IV Carboplatin Once Every 3 Weeks Versus IV Paclitaxel Weekly Plus Intraperitoneal (IP) Carboplatin Once Every 3 Weeks in Women With Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
This is a randomized, multicenter international study. Patient are stratified according to
Residual tumor diameter([0cm(No residual)] vs. [0cm<residual<1cm] vs. [1cm
the treatment arms described below.
RegimenI(Standard treatment: dd-TCiv therapy): Paclitaxel administered by IV infusion
weekly plus concurrent carboplatin administered by IV infusion once every 3 weeks
RegimenII(Study treatment: dd-TCip therapy): Paclitaxel administered by IV infusion weekly
plus concurrent carboplatin administered by IP injection once every 3 weeks
The 3-week period (21 days) is 1 cycle. Protocol treatment basically comprises 6 cycles. IDS
is allowed to be performed after 3, 4 or 5 cycles of the protocol treatment. In such cases,
the protocol treatment must be restarted within 8 weeks after IDS. If IDS is performed,
patients can receive up to 3 additional cycles of the protocol treatment after IDS. If
interval debulking surgery (IDS) is performed after 3, 4 or 5 cycles, the patients can
receive up to 3 additional cycles of the protocol treatment. A total of 6 to 8 cycles will
be repeated.
The analysis of efficacy will be performed on all randomized subjects in accordance with the
intention-to-treat (ITT) principle. In order to assess the robustness of the results, the
same analyses will be done using all randomized subjects who satisfy the eligibility
criteria. The analysis of safety will be performed on all subjects who have received at
least one dose of study treatment.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival(PFS)
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed until 510 events are observed or until 3 years from the last patient is randomized to the study
No
Keiichi Fujiwara, MD, PhD
Study Chair
Saitama Medical University International Medical Center Comprehensive Cancer Center
Japan: Ministry of Health, Labor and Welfare
GOTIC-001/JGOG3019
NCT01506856
May 2010
October 2018
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