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

Phase 3

Completed

• Conditions: Primary Peritoneal Cancer; Epithelial Ovarian Cancer; Fallopian Tube Cancer
• Interventions: Drug: Paclitaxel+Carboplatin

• Registration Number: NCT00226915
• Lead Sponsor: Japanese Gynecologic Oncology Group

Brief 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.

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2005-09-23
• Study First Submitted QC: 2005-09-26
• Study First Posted: 2005-09-27
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-12
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 637

Inclusion Criteria

• Histologically confirmed stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer
• No prior chemotherapy
• Age: 20 and more
• Performance status: ECOG 0-3
• 1. Absolute neutrophil count at least 1,500/mm3 2) Platelet count at least 100,000/mm3 3) Bilirubin less than 1.5mg/dL 4) SGOT less than 100 IU/l 5) Serum creatinine less than 1.5mg/dL
• Written informed consent

Exclusion Criteria

• Patients with ovarian borderline tumor
• Patients who have any evidence of the other cancer present within the last 5 years with the exception of carcinoma in situ or intramucosal cancer that is curable with local therapy
• Patients with active infection or uncontrolled diabetes
• Patients with unstable angina, or those who have had a myocardial infarction within the past 6 months, or patients with serious arrythmia that requires medication
• Patients who have a history of hypersensitivity to polyoxyethylated castor oil (Cremophor EL)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Paclitaxel+Carboplatin	Drug: Paclitaxel 80mg/m2 weekly ＋CBDCA AUC6 q21 days x 6-9cycles
1	Paclitaxel+Carboplatin	Drug: Paclitaxel 180mg/m2＋CBDCA AUC6 q21 days x 6-9cycles

Primary Outcome Measures

Name	Time	Method
Progression Free Suvaival	During the protocol treatment then 18 months from the last day of the protocol treatment	From the registration date, the earliest observed event from any of the following events 1. Death from any cause death date 2. The date of the first diagnostic imaging examination that confirmed exacerbation and recurrence.; Clinical exacerbation diagnosis date if not based on diagnostic imaging 3. If none of the above events are observed, the most recent outpatient consultation date / in hospital

Secondary Outcome Measures

Name	Time	Method
QOL	During the protocol treatment then 18 months	QOL assessed by FACT-Taxane(Version 4A)
Adverse Event	During the protocol treatment then 18 months	Adverse Event assessed by CTC(Version 2.0 Japanese version)
Overall Survival	During the protocol treatment then 18 months from the last day of the protocol treatment	The period from the registration date to the date of death due to any cause. In the case of survivors, the final surviving confirmation date will be censored.; In the case of untraceable cases, the last surviving confirmation date before tracking becomes impossible will be censored.

Trial Locations

Locations (1)

National Cancer Center Hospital; 🇯🇵 Chuo-ku, Tokyo, Japan