Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045630
Status:
COMPLETED
Last Update Posted:
2013-05-27
First Post:
2002-09-06
Brief Title:
S0219 Combination Chemotherapy Followed By Observation or Surgery in Patients With Stage II or Stage III Cancer of the Urothelium
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Sequential Approach to the Treatment of Muscle Invasive Non-Metastatic Urothelial Carcinoma of the Bladder A Phase II Trial of Neoadjuvant Gemcitabine Paclitaxel and Carboplatin With Molecular Correlates
Status:
COMPLETED
Status Verified Date:
2013-04
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 and decrease the need for surgery
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by observation or surgery to remove the bladder cystectomy in treating patients who have stage II or stage III cancer of the urothelium
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by observation or surgery to remove the bladder cystectomy in treating patients who have stage II or stage III cancer of the urothelium
Detailed Description:
OBJECTIVES
Determine the pathologic complete response of patients with stage II or III transitional cell cancer of the urothelium treated with neoadjuvant gemcitabine paclitaxel and carboplatin followed by observation or immediate cystectomy
Determine preliminarily if molecular markers predict response survival and tumor recurrence in patients treated with these regimens
Determine recurrence rates and cystectomy-free survival of patients who choose observation after an initial response to neoadjuvant chemotherapy
Compare the survival of patients treated with neoadjuvant chemotherapy followed by cystectomy vs observation
Determine the feasibility tolerability and toxicity of these regimens in these patients
OUTLINE This is a multicenter study
Patients receive gemcitabine IV over 30 minutes and paclitaxel IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1 Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
Within 4-8 weeks after completion of neoadjuvant chemotherapy patients undergo a third transurethral resection of bladder tumor
Patients with T0 disease after neoadjuvant chemotherapy may choose to undergo observation These patients undergo cystoscopies with biopsies every 3 months for 1 year every 4 months for 1 year and then every 6 months until disease progression
Patients with T1 disease or greater after neoadjuvant chemotherapy undergo immediate cystectomy Patients with T0 disease may also choose this option Patients undergoing immediate cystectomy are followed every 6 months for 2 years and then annually for 3 years
PROJECTED ACCRUAL A total of 95 patients will be accrued for this study within 2 years
Determine the pathologic complete response of patients with stage II or III transitional cell cancer of the urothelium treated with neoadjuvant gemcitabine paclitaxel and carboplatin followed by observation or immediate cystectomy
Determine preliminarily if molecular markers predict response survival and tumor recurrence in patients treated with these regimens
Determine recurrence rates and cystectomy-free survival of patients who choose observation after an initial response to neoadjuvant chemotherapy
Compare the survival of patients treated with neoadjuvant chemotherapy followed by cystectomy vs observation
Determine the feasibility tolerability and toxicity of these regimens in these patients
OUTLINE This is a multicenter study
Patients receive gemcitabine IV over 30 minutes and paclitaxel IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1 Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
Within 4-8 weeks after completion of neoadjuvant chemotherapy patients undergo a third transurethral resection of bladder tumor
Patients with T0 disease after neoadjuvant chemotherapy may choose to undergo observation These patients undergo cystoscopies with biopsies every 3 months for 1 year every 4 months for 1 year and then every 6 months until disease progression
Patients with T1 disease or greater after neoadjuvant chemotherapy undergo immediate cystectomy Patients with T0 disease may also choose this option Patients undergoing immediate cystectomy are followed every 6 months for 2 years and then annually for 3 years
PROJECTED ACCRUAL A total of 95 patients will be accrued for this study within 2 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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0219 | OTHER | None | None |