A Phase 2/3 interventional study of Paclitaxel(intravenous) + Carboplatin(intravenous) and Paclitaxel(intravenous) + Carboplatin(intraperitoneal) in Epithelial Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Carcinoma, sponsored by Gynecologic Oncology Trial & Investigation Consortium. Completed at 62 sites in 6 countries. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-09-15.
Sponsored by Gynecologic Oncology Trial & Investigation Consortium · Phase 2/3, Interventional, and Treatment
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 655 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →This is the only study on the registry with Gynecologic Oncology Trial & Investigation Consortium as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients scheduled to undergo laparotomy
*Both optimal and suboptimal patients will be eligible for the study (Suboptimal patients, as well as those who undergo only exploratory laparotomy, are eligible.)
Lab data and clinical examination: Data within 28 days before the scheduled date of surgery
Exclusion Criteria:
Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IV infusion once every 3 weeks
Drug: Paclitaxel(intravenous) + Carboplatin(intravenous)
Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IP injection once every 3 weeks
Drug: Paclitaxel(intravenous) + Carboplatin(intraperitoneal)
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.
Also known as: Paclitaxel(Sawai),(NK), Paraplatin(BMS), Carboplatin(SANDOZ)
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.
Also known as: Paclitaxel(Sawai),(NK), Paraplatin(BMS), Carboplatin(SANDOZ)
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 study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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