Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054626
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2003-02-05
Brief Title:
Cisplatin and Gemcitabine Compared With Observation in Treating Patients Who Have Undergone Surgery for Bladder Cancer
Sponsor:
Fondazione CNRRegione Toscana G Monasterio Pisa Italy
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Study Of Adjuvant Cisplatin-Gemcitabine Vs Observation After Radical Cystectomy In High-Risk Bladder Cancer
Status:
UNKNOWN
Status Verified Date:
2008-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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 cancer cells from dividing so they stop growing or die It is not yet known if combination chemotherapy is effective in preventing relapse in patients who have undergone radical cystectomy for bladder cancer
PURPOSE Phase III trial to compare the effectiveness of cisplatin combined with gemcitabine with that of observation in treating patients with bladder cancer who have undergone surgery to remove the bladder
PURPOSE Phase III trial to compare the effectiveness of cisplatin combined with gemcitabine with that of observation in treating patients with bladder cancer who have undergone surgery to remove the bladder
Detailed Description:
OBJECTIVES
Compare the overall cause-specific and disease-free survival of patients with high-risk muscle-invasive transitional cell carcinoma of the bladder treated with adjuvant cisplatin and gemcitabine vs observation after radical cystectomy
Compare the dose intensity and toxicity of two different schedules of cisplatin and gemcitabine in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center and disease status T2 G3 only or T3-4 any G N0-2 vs any T N1-2 M0 Patients are randomized to 1 of 2 treatment arms
Arm I Patients are further randomized to 1 of 2 treatment regimens
Regimen A Patients receive cisplatin IV on day 2 and gemcitabine IV on days 1 8 and 15
Regimen B Patients receive cisplatin IV on day 15 and gemcitabine as in regimen A
Treatment in both regimens repeats every 28 days for 4 courses
Arm II Patients undergo observation followed by cisplatin and gemcitabine as in arm I at relapse
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 700 patients 350 per treatment arm will be accrued for this study within 3 years
Compare the overall cause-specific and disease-free survival of patients with high-risk muscle-invasive transitional cell carcinoma of the bladder treated with adjuvant cisplatin and gemcitabine vs observation after radical cystectomy
Compare the dose intensity and toxicity of two different schedules of cisplatin and gemcitabine in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center and disease status T2 G3 only or T3-4 any G N0-2 vs any T N1-2 M0 Patients are randomized to 1 of 2 treatment arms
Arm I Patients are further randomized to 1 of 2 treatment regimens
Regimen A Patients receive cisplatin IV on day 2 and gemcitabine IV on days 1 8 and 15
Regimen B Patients receive cisplatin IV on day 15 and gemcitabine as in regimen A
Treatment in both regimens repeats every 28 days for 4 courses
Arm II Patients undergo observation followed by cisplatin and gemcitabine as in arm I at relapse
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 700 patients 350 per treatment arm will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V02-1715 | None | None | None |
| ITNRC-CU0200447ST97 | None | None | None |