Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024349
Status:
COMPLETED
Last Update Posted:
2013-12-18
First Post:
2001-09-13
Brief Title:
Radiation Therapy With or Without Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
Sponsor:
University Hospital Birmingham
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
2X2 Factorial Randomized Phase III Study Comparing Standard Versus Reduced Volume Radiotherapy With and Without Synchronous Chemotherapy in Muscle Invasive Bladder Cancer
Status:
COMPLETED
Status Verified Date:
2007-05
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 Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy such as fluorouracil and mitomycin use different ways to stop tumor cells from dividing so they stop growing or die Fluorouracil and mitomycin may make the tumor cells more sensitive to radiation therapy It is not yet known if radiation therapy is more effective with or without chemotherapy in treating bladder cancer
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy to all or part of the bladder with or without chemotherapy in treating patients who have stage II or stage III bladder cancer
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy to all or part of the bladder with or without chemotherapy in treating patients who have stage II or stage III bladder cancer
Detailed Description:
OBJECTIVES
Compare the efficacy of standard volume radiotherapy vs reduced volume radiotherapy with or without synchronous fluorouracil and mitomycin in patients with stage II or III muscle invasive bladder cancer
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center prior neoadjuvant chemotherapy yes vs no and intent to enter only 1 of the possible 2 randomizations on study yes vs no Patients are randomized to one of two treatment arms
Arm I Patients undergo standard radiotherapy once daily 5 days a week for 4 or 65 weeks Patients also receive synchronous chemotherapy comprising mitomycin IV on day 1 and fluorouracil IV continuously over days 1-5 and 16-20 during radiotherapy
Arm II Patients undergo standard radiotherapy as in arm I without chemotherapy
If standard radiotherapy is clearly indicated eg patients with multiple tumors patients may be randomized to standard radiotherapy with or without chemotherapy arms I or III above If chemotherapy is clearly contraindicated patients are randomized to standard or reduced volume radiotherapy without chemotherapy arms III or IV above
Quality of life is assessed at baseline at the end of therapy at 6 and 12 months post-randomization and then annually for at least 5 years
Patients are followed at 6 9 and 12 months post-randomization and then at least annually thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 350 patients will be accrued for this study
Compare the efficacy of standard volume radiotherapy vs reduced volume radiotherapy with or without synchronous fluorouracil and mitomycin in patients with stage II or III muscle invasive bladder cancer
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center prior neoadjuvant chemotherapy yes vs no and intent to enter only 1 of the possible 2 randomizations on study yes vs no Patients are randomized to one of two treatment arms
Arm I Patients undergo standard radiotherapy once daily 5 days a week for 4 or 65 weeks Patients also receive synchronous chemotherapy comprising mitomycin IV on day 1 and fluorouracil IV continuously over days 1-5 and 16-20 during radiotherapy
Arm II Patients undergo standard radiotherapy as in arm I without chemotherapy
If standard radiotherapy is clearly indicated eg patients with multiple tumors patients may be randomized to standard radiotherapy with or without chemotherapy arms I or III above If chemotherapy is clearly contraindicated patients are randomized to standard or reduced volume radiotherapy without chemotherapy arms III or IV above
Quality of life is assessed at baseline at the end of therapy at 6 and 12 months post-randomization and then annually for at least 5 years
Patients are followed at 6 9 and 12 months post-randomization and then at least annually thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 350 patients will be accrued for this study
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 |
|---|---|---|---|
| ISRCTN68324339 | None | None | None |
| CRC-BC2001 | None | None | None |
| EU-20052 | None | None | None |