NCT00226915

Trial of Tri-weekly TJ Versus Weekly TJ for Stage II-IV Mullerian Carcinoma

Randomized Phase III Trial of Conventional Paclitaxel and Carboplatin Versus Dose Dense Weekly Paclitaxel and Carboplatin in Patients With Newly Diagnosed Stage II-IV Mullerian Carcinoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 637 (actual)
• Sponsor: Japanese Gynecologic Oncology Group · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to compare progression-free survival of conventional paclitaxel and carboplatin vs weekly paclitaxel and carboplatin in patients with newly diagnosed stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer.

Detailed description

This is a randomized, multicenter study. Patients are stratified according to residual disease 1 cm or less vs more than 1cm, stage II vs III vs IV, and histology (clear cell or mucinous vs. serous or others). Patients are randomized to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 60 minutes on day 1 for 6-9 cycles. Arm II: Patients receive paclitaxel IV over 1 hour days 1, 8, and 15 and carboplatin IV over 60 minutes on day 1 for 6-9 cycles. In both arms, cycles repeat 6 cycles every 21 days in the absence of disease progression or unacceptable toxicity. Additional 3 cycles are given if clinical partial or complete response after 6 cycles. PROJECTED ACCRUAL: A total 600 patients (300 per treatment arm) will be accrued for this study within 3 years. Assuming median progression-free survivals of 16 months and 21 months and a recruitment period of 3 years this can be achieved by recruiting 600 patients designed to have 80 % detect to a difference between the two arms at the two-sided 5% level of statistical significance.

Conditions

• Epithelial Ovarian Cancer
• Primary Peritoneal Cancer
• Fallopian Tube Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel+Carboplatin	Paclitaxel 180mg/m2＋CBDCA AUC6 q21 days x 6-9cycles
DRUG	Paclitaxel+Carboplatin	Paclitaxel 80mg/m2 weekly ＋CBDCA AUC6 q21 days x 6-9cycles

Timeline

• Start date: 2003-04-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2005-09-27
• Last updated: 2020-02-17

Locations

1 site across 1 country: Japan