CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 655 enrolled
Drug / intervention
Paclitaxel(intravenous) + Carboplatin(intravenous) +1 moredrug
Likely dose
Paclitaxel(intravenous) + Carboplatin(intravenous) 80mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01506856
NCT01506856Phase 3Completed
CompareCT.gov

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

Gynecologic Oncology Trial & Investigation Consortium·interventional·Posted Jan 10, 2012·Updated Sep 15, 2023

In Brief

A Phase 3 clinical trial evaluating Paclitaxel(intravenous) + Carboplatin(intravenous) and Paclitaxel(intravenous) + Carboplatin(intraperitoneal) for Epithelial Ovarian Cancer and 2 related conditions. Completed, enrolled 655 participants across 62 sites in 6 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
CountriesHong Kong, Japan, New Zealand, Singapore, South Korea, United States
CollaboratorsJapanese Gynecologic Oncology Group

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 10, 2012
Enrollment StartMay 1, 2010
Primary CompletionFeb 28, 2021
TodayJul 2, 2026
Enrollment to primary: 10.8 yearsPosted 14.5 years ago

Interventions

Paclitaxel(intravenous) + Carboplatin(intravenous)drug

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)drug

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.