The purpose of this study is: Phase A: To confirm the feasibility of paclitaxel administered by intravenous (IV) infusion weekly plus concurrent carboplatin administered by intraperitoneal (IP) injection once every 3 weeks (dd-TCip therapy). Phase B: To compare the efficacy and safety of the following two treatment regimens as first-line chemotherapy 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. \[1cm\<residual\<2cm\] vs. \[\>2 cm\]), FIGO stage(StageII vs. III vs. IV) and institution. Patient randomized to one of 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
655
Paclitaxel(intravenous) + Carboplatin(intravenous) Paclitaxel : 80mg/m2, IV infusion, Day1, 8, and 15 Carboplatin: AUC=6.0, IV infusion, Day1 A total of 6 to 8 cycles will be repeated.
Paclitaxel(intravenous) + Carboplatin(intraperitoneal) Paclitaxel : 80mg/m2, IV infusion, Day1, 8, and 15 Carboplatin: AUC=6.0, IP injection, Day1 A total of 6 to 8 cycles will be repeated.
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Queen Mary Hospital
Hong Kong, High West, Hong Kong
Aichi Cancer Center Hospital
Chikusa, Aichi-ken, Japan
Hirosaki University School of Medicine & Hospital
Hirosaki-shi, Aomori, Japan
The Jikei University School of Medicine, Kashiwa Hospital
Kashiwa, Chiba, Japan
Progression-free survival(PFS)
Time frame: 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
Overall survival (OS)
Time frame: weekly during the protocl treatment, then every 3 months for the first 2 years, 6-month for the following 2 years, and once a year thereafter
Tumor response (only patients with evaluable disease)
Time frame: every 2 cycles [after 2 cycles, after 4 cycles, after 6 cycles, (after 8 cycles)], the time of discontinuation of the protocol treatment and then at least annually during follow-up
Adverse events
Time frame: weekly during the protocl treatment, then every 3 months for the first 2 years, 6-month for the following 2 years, and once a year thereafter
Treatment completion rate
Time frame: After the last cycle of the protocol teatment
Quality of Life (QOL) assessments
Time frame: baseline, after 3 cycles, 6 cycles, 36 week, 60 weeks and 84 weeks from the start of protocol treatment
Cost-utility analysis
Time frame: baseline, after 3 cycles, 6 cycles, 36 week, 60 weeks and 84 weeks from the start of protocol treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
NHO Shikoku Cancer Center
Matsuyama, Ehime, Japan
Ehime University Hospital
Toon-shi, Ehime, Japan
University of Fukui Hospital
Yoshida, Fukui, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
Gunma Prefectural Cancer Center
Ōta, Gunma, Japan
...and 52 more locations