MedTrace Logo

Intraperitoneal Therapy For Ovarian Cancer With Carboplatin Trial

NCT01506856 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 655

Last updated 2023-09-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Paclitaxel(intravenous) + Carboplatin(intravenous)

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.

DRUG

Paclitaxel(intravenous) + Carboplatin(intraperitoneal)

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.

Sponsors & Collaborators

  • Japanese Gynecologic Oncology Group

    collaborator OTHER

  • Gynecologic Oncology Trial & Investigation Consortium

    lead NETWORK

Principal Investigators

  • Keiichi Fujiwara, MD, PhD · Saitama Medical University International Medical Center Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2021-02-28
Completion
2021-02-28

Countries

  • United States
  • Hong Kong
  • Japan
  • New Zealand
  • Singapore
  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01506856 on ClinicalTrials.gov