Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003642
Status:
TERMINATED
Last Update Posted:
2012-03-06
First Post:
1999-11-01
Brief Title:
Radiation Therapy and Chemotherapy Following Surgery 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 Phase II Feasibility Study of Combined Accelerated External Radiation and Chemotherapy With 5FU and CDDP Following Transurethral Resection in Patients With Muscle Invasive Transitional Carcinoma of the Bladder - T2-T3 N0 M0 UICC 1992
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 Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug and combining radiation therapy with chemotherapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of radiation therapy combined with fluorouracil and cisplatin in treating patients who have stage II or stage III bladder cancer and who have undergone transurethral resection
PURPOSE Phase II trial to study the effectiveness of radiation therapy combined with fluorouracil and cisplatin in treating patients who have stage II or stage III bladder cancer and who have undergone transurethral resection
Detailed Description:
OBJECTIVES I Evaluate the rate of severe acute toxicity occurring during therapy with accelerated external radiotherapy with concurrent fluorouracil 5-FU and cisplatin following transurethral resection of the bladder in patients with stage II or III muscle invasive transitional cell carcinoma of the bladder II Evaluate the rate of freedom from local recurrence to this combined therapy assessed 3 months after the end of treatment in these patients III Assess the feasibility of this new therapeutic approach in this patient population IV Determine the overall recurrent free survival long term side effects and overall survival in these patients
OUTLINE This is an open label multicenter study Patients undergo accelerated external radiotherapy twice daily 5 days a week for 5 weeks Concurrent chemotherapy is administered on the first and fifth week consisting of cisplatin IV over 2 hours daily and fluorouracil by 24 hour continuous infusion daily on days 1-5 Patients are followed at 3 months then every 3 months for the first 2 years and then every 6 months thereafter
PROJECTED ACCRUAL There will be 19-43 patients accrued into this study
OUTLINE This is an open label multicenter study Patients undergo accelerated external radiotherapy twice daily 5 days a week for 5 weeks Concurrent chemotherapy is administered on the first and fifth week consisting of cisplatin IV over 2 hours daily and fluorouracil by 24 hour continuous infusion daily on days 1-5 Patients are followed at 3 months then every 3 months for the first 2 years and then every 6 months thereafter
PROJECTED ACCRUAL There will be 19-43 patients accrued into 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-22971 | None | None | None |