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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Epithelial Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer

Intervention / Treatment
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* Drug: Paclitaxel+Carboplatin
* Drug: Paclitaxel+Carboplatin


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Drug: Paclitaxel 180mg/m2＋CBDCA AUC6 q21 days x 6-9cycles | Drug: Paclitaxel+Carboplatin<br>* Paclitaxel 180mg/m2＋CBDCA AUC6 q21 days x 6-9cycles<br>|
| Experimental: 2<br>Drug: Paclitaxel 80mg/m2 weekly ＋CBDCA AUC6 q21 days x 6-9cycles | Drug: Paclitaxel+Carboplatin<br>* Paclitaxel 80mg/m2 weekly ＋CBDCA AUC6 q21 days x 6-9cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Suvaival | 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 | During the protocol treatment then 18 months from the last day of the protocol treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | 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. | During the protocol treatment then 18 months from the last day of the protocol treatment | 
| QOL | QOL assessed by FACT-Taxane(Version 4A) | During the protocol treatment then 18 months | 
| Adverse Event | Adverse Event assessed by CTC(Version 2.0 Japanese version) | During the protocol treatment then 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian neoplasms, randomized controlled trial, paclitaxel, carboplatin