Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003640
Status:
TERMINATED
Last Update Posted:
2012-03-06
First Post:
1999-11-01
Brief Title:
Transurethral Resection and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Feasibility Study of Thorough Transurethral Resection TURB and Escalated Dose M-VAC Chemotherapy as Primary Treatment of T2-T3a N0-Nx M0 Transitional Cell Carcinoma of the Bladder With the Intention of Bladder Preservation
Status:
TERMINATED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
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 Combination chemotherapy combined with transurethral resection may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of transurethral resection plus combination chemotherapy in treating patients who have stage II or stage III bladder cancer
PURPOSE Phase II trial to study the effectiveness of transurethral resection plus combination chemotherapy in treating patients who have stage II or stage III bladder cancer
Detailed Description:
OBJECTIVES I Determine the percentage of patients with transitional cell carcinoma of the bladder who are disease free or who have minimal disease 3 months after thorough transurethral resection TURB and escalated dose methotrexatevinblastinedoxorubicincisplatin M-VAC chemotherapy II Evaluate the combination of thorough TURB and escalated dose M-VAC followed by radiotherapy with respect to bladder preservation for patients who respond to neoadjuvant chemotherapy III Evaluate the proportion of patients remaining disease free and not requiring cystectomy at 1 year IV Evaluate the feasibility and morbidity of this treatment schedule in multiple institutions applied by urologists of possibly varying endoscopic ability
OUTLINE This is a multicenter study Patients undergo a local transurethral resection Patients then receive methotrexate IV on day 1 followed by vinblastine IV doxorubicin IV and cisplatin IV on day 2 Filgrastim G-CSF is administered on days 4-10 Chemotherapy is repeated every 14 days for 3 courses After the end of chemotherapy patients undergo another local transurethral resection in order to define response to treatment Patients with minimal or no disease are treated with radiotherapy Patients who still have disease undergo a cystectomy Patients are followed every 3 months for the first 2 years and then every 6 months until death
PROJECTED ACCRUAL A total of 29-73 patients will be accrued for this study
OUTLINE This is a multicenter study Patients undergo a local transurethral resection Patients then receive methotrexate IV on day 1 followed by vinblastine IV doxorubicin IV and cisplatin IV on day 2 Filgrastim G-CSF is administered on days 4-10 Chemotherapy is repeated every 14 days for 3 courses After the end of chemotherapy patients undergo another local transurethral resection in order to define response to treatment Patients with minimal or no disease are treated with radiotherapy Patients who still have disease undergo a cystectomy Patients are followed every 3 months for the first 2 years and then every 6 months until death
PROJECTED ACCRUAL A total of 29-73 patients will be accrued for this study
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 |
|---|---|---|---|
| EORTC-30971 | None | None | None |