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Sponsored by: |
Japanese Gynecologic Oncology Group |
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Information provided by: | Japanese Gynecologic Oncology Group |
ClinicalTrials.gov Identifier: | NCT00226915 |
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.
Condition | Intervention | Phase |
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Epithelial Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer |
Drug: Paclitaxel+Carboplatin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Enrollment: | 637 |
Study Start Date: | April 2003 |
Study Completion Date: | November 2007 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Drug: Paclitaxel 180mg/m2+CBDCA AUC6 q21 days x 6-9cycles
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Drug: Paclitaxel+Carboplatin
Paclitaxel 180mg/m2+CBDCA AUC6 q21 days x 6-9cycles
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2: Experimental
Drug: Paclitaxel 80mg/m2 weekly +CBDCA AUC6 q21 days x 6-9cycles
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Drug: Paclitaxel+Carboplatin
Paclitaxel 80mg/m2 weekly +CBDCA AUC6 q21 days x 6-9cycles
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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.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan, Tokyo | |
National Cancer Center Hospital | |
Chuo-ku, Tokyo, Japan |
Study Chair: | Makoto Yasuda, M.D. | The Jikei University School of Medicine |
Responsible Party: | Japanese Gynecologic Oncology Group ( Kiichirou Noda / President ) |
Study ID Numbers: | JGOG3016, C000000183 (by UMIN) |
Study First Received: | September 23, 2005 |
Last Updated: | May 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00226915 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
ovarian neoplasms randomized controlled trial paclitaxel carboplatin |
Fallopian Tube Cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Antimitotic Agents Carboplatin Ovarian Diseases Ovarian Epithelial Cancer |
Fallopian Tube Neoplasms Carcinoma Fallopian Tube Diseases Genital Diseases, Female Paclitaxel Tubulin Modulators Ovarian Cancer Endocrinopathy Antineoplastic Agents, Phytogenic Endocrine Gland Neoplasms |
Ovarian Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gonadal Disorders Mitosis Modulators Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Antimitotic Agents Carboplatin Ovarian Diseases Pharmacologic Actions |
Fallopian Tube Neoplasms Adnexal Diseases Fallopian Tube Diseases Genital Diseases, Female Neoplasms Neoplasms by Site Paclitaxel Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic Endocrine Gland Neoplasms |