Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003701
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Bladder Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase III Randomized Trial of Either M-VAC or Paclitaxel Carboplatin as Postoperative Adjuvant Therapy in Patients With Muscle-Invasive Transitional Cell Carcinoma of the Bladder at High-Risk for Relapse
Status:
COMPLETED
Status Verified Date:
2023-06
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells It is not yet known whether four-drug combination chemotherapy is more effective than two-drug combination chemotherapy in treating bladder cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have bladder cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have bladder cancer
Detailed Description:
OBJECTIVES I Compare the recurrence rates and overall survival of patients treated with postoperative adjuvant methotrexate vinblastine doxorubicin and cisplatin M-VAC to those treated with combination paclitaxel and carboplatin for muscle invasive bladder cancer at particularly high risk of relapse II Compare the relative toxicities of postoperative M-VAC versus those encountered with postoperative paclitaxel and carboplatin III Compare the quality of life scores during and following completion of treatment of patients in these two treatment arms
OUTLINE This is a randomized study Patients are stratified by N stage N0 vs N and performance status 0-1 vs 2 Patients are randomized to receive methotrexate vinblastine doxorubicin and cisplatin arm I or paclitaxel and carboplatin arm II Arm I Patients receive methotrexate IV push on days 1 15 and 22 vinblastine IV push on days 2 15 and 22 doxorubicin IV push on day 2 and cisplatin IV over 2 hours on day 2 Treatment repeats every 28 days for 4 courses Arm II Patients receive paclitaxel IV over 3 hours on days 1 followed by carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for 4 courses Quality of life assessments are completed pretreatment prior to course 3 6 weeks after the last dose of chemotherapy and at 6 12 and 24 months from the end of therapy Patients are followed every 3 months until year 2 every 6 months for years 2-5 and then annually thereafter
PROJECTED ACCRUAL There will be 490 patients accrued into this study within 26 years
OUTLINE This is a randomized study Patients are stratified by N stage N0 vs N and performance status 0-1 vs 2 Patients are randomized to receive methotrexate vinblastine doxorubicin and cisplatin arm I or paclitaxel and carboplatin arm II Arm I Patients receive methotrexate IV push on days 1 15 and 22 vinblastine IV push on days 2 15 and 22 doxorubicin IV push on day 2 and cisplatin IV over 2 hours on day 2 Treatment repeats every 28 days for 4 courses Arm II Patients receive paclitaxel IV over 3 hours on days 1 followed by carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for 4 courses Quality of life assessments are completed pretreatment prior to course 3 6 weeks after the last dose of chemotherapy and at 6 12 and 24 months from the end of therapy Patients are followed every 3 months until year 2 every 6 months for years 2-5 and then annually thereafter
PROJECTED ACCRUAL There will be 490 patients accrued into this study within 26 years
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 |
|---|---|---|---|
| E-1897 | None | None | None |