Brief Title
Trial of Tri-weekly TJ Versus Weekly TJ for Stage II-IV Mullerian Carcinoma
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
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 Phase
Phase 3
Study Type
Interventional
Primary Outcome
Progression Free Suvaival
Secondary Outcome
Overall Survival
Condition
Epithelial Ovarian Cancer
Intervention
Paclitaxel+Carboplatin
Study Arms / Comparison Groups
1
Description: Drug: Paclitaxel 180mg/m2＋CBDCA AUC6 q21 days x 6-9cycles
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
637
Start Date
April 2003
Completion Date
June 2012
Primary Completion Date
June 2012
Eligibility Criteria
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)
Gender
Female
Ages
20 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Makoto Yasuda, M.D., ,
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT00226915
Organization ID
JGOG3016
Secondary IDs
C000000183 (by UMIN)
Responsible Party
Sponsor
Study Sponsor
Japanese Gynecologic Oncology Group
Study Sponsor
Makoto Yasuda, M.D., Study Chair, The Jikei University School of Medicine
Verification Date
February 2020