Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00226915
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2005-09-23
Brief Title:
Trial of Tri-weekly TJ Versus Weekly TJ for Stage II-IV Mullerian Carcinoma
Sponsor:
Japanese Gynecologic Oncology Group
Organization:
Japanese Gynecologic Oncology Group
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| C000000183 by UMIN | None | None | None |