Trial of Tri-weekly TJ Versus Weekly TJ for Stage II-IV Mullerian Carcinoma
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| ClinicalTrials.gov Identifier: NCT00226915 |
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Recruitment Status :
Completed
First Posted : September 27, 2005
Last Update Posted : February 17, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Epithelial Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer | Drug: Paclitaxel+Carboplatin | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 637 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | April 2003 |
| Actual Primary Completion Date : | June 2012 |
| Actual Study Completion Date : | June 2012 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
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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Experimental: 2
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 |
- Progression Free Suvaival [ Time Frame: 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
- Overall Survival [ Time Frame: 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.
- QOL [ Time Frame: During the protocol treatment then 18 months ]QOL assessed by FACT-Taxane(Version 4A)
- Adverse Event [ Time Frame: During the protocol treatment then 18 months ]Adverse Event assessed by CTC(Version 2.0 Japanese version)
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| Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00226915
| Japan | |
| National Cancer Center Hospital | |
| Chuo-ku, Tokyo, Japan | |
| Study Chair: | Makoto Yasuda, M.D. | The Jikei University School of Medicine |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Japanese Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00226915 |
| Other Study ID Numbers: |
JGOG3016 C000000183 (by UMIN) |
| First Posted: | September 27, 2005 Key Record Dates |
| Last Update Posted: | February 17, 2020 |
| Last Verified: | February 2020 |
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ovarian neoplasms randomized controlled trial paclitaxel carboplatin |
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Fallopian Tube Neoplasms Carcinoma, Ovarian Epithelial Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases |
Genital Neoplasms, Female Urogenital Neoplasms Genital Diseases Endocrine System Diseases Gonadal Disorders Fallopian Tube Diseases Paclitaxel Albumin-Bound Paclitaxel Carboplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |