Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006111
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2000-08-03
Brief Title:
Surgery Plus Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Urinary Tract
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Multicenter Study of the Quality of Life of Patients With Invasive Urothelial Cancer Treated With Conservative Surgery Followed by Cisplatin Fluorouracil and Radiotherapy
Status:
COMPLETED
Status Verified Date:
2021-02
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 Radiation therapy uses high-energy x-rays to damage tumor cells Combining surgery with chemotherapy and radiation therapy may be an effective way to treat cancer of the urinary tract
PURPOSE Phase II trial to study the effectiveness of combining surgery chemotherapy and radiation therapy in treating patients who have stage II stage III or stage IV cancer of the urinary tract
PURPOSE Phase II trial to study the effectiveness of combining surgery chemotherapy and radiation therapy in treating patients who have stage II stage III or stage IV cancer of the urinary tract
Detailed Description:
OBJECTIVES I Assess the quality of life of patients with invasive stage II III or IV carcinoma of the urothelium treated with conservative surgery plus cisplatin fluorouracil and radiotherapy II Determine the efficacy of this regimen in terms of local control in these patients III Determine survival of patients treated with this regimen IV Determine the toxic effects of this regimen in these patients
OUTLINE This is a multicenter study Patients are stratified according to tumor type T2-4a N0 M0 potentially resectable no contraindication to surgery vs T2-4b N0 or N1 or pN1 M0 refused surgery or medical contraindications to surgery Accrual for stratum I was completed as of 10232001 Stratum I resectable disease Regimen A Patients undergo radiotherapy 5 days a week for 5 weeks Patients also receive fluorouracil IV continuously and cisplatin IV continuously on days 1-4 during weeks 1 and 4 If complete response is achieved by week 5 patients proceed to regimen B If partial response or progression is observed patients undergo cystectomy If cystectomy is refused patients proceed to regimen B Regimen B Patients undergo radiotherapy 5 days a week for 2 weeks Patients also receive fluorouracil and cisplatin as in regimen A on weeks 2 and 5 Accrual for stratum I was completed as of 10232001 Stratum II unresectable disease Patients undergo radiotherapy 5 days a week for 7 weeks Patients also receive fluorouracil and cisplatin as in regimen A on weeks 1 4 and 7 Quality of life is assessed at baseline at 6 months and then at 1 year Patients are followed at 6-8 weeks every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 75 patients 35 for stratum I and 40 for stratum II will be accrued for this study Accrual for stratum I was completed as of 10232001
OUTLINE This is a multicenter study Patients are stratified according to tumor type T2-4a N0 M0 potentially resectable no contraindication to surgery vs T2-4b N0 or N1 or pN1 M0 refused surgery or medical contraindications to surgery Accrual for stratum I was completed as of 10232001 Stratum I resectable disease Regimen A Patients undergo radiotherapy 5 days a week for 5 weeks Patients also receive fluorouracil IV continuously and cisplatin IV continuously on days 1-4 during weeks 1 and 4 If complete response is achieved by week 5 patients proceed to regimen B If partial response or progression is observed patients undergo cystectomy If cystectomy is refused patients proceed to regimen B Regimen B Patients undergo radiotherapy 5 days a week for 2 weeks Patients also receive fluorouracil and cisplatin as in regimen A on weeks 2 and 5 Accrual for stratum I was completed as of 10232001 Stratum II unresectable disease Patients undergo radiotherapy 5 days a week for 7 weeks Patients also receive fluorouracil and cisplatin as in regimen A on weeks 1 4 and 7 Quality of life is assessed at baseline at 6 months and then at 1 year Patients are followed at 6-8 weeks every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 75 patients 35 for stratum I and 40 for stratum II will be accrued for this study Accrual for stratum I was completed as of 10232001
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 |
|---|---|---|---|
| EU-20009 | None | None | None |
| FRE-FNCLCC-97015 | None | None | None |