Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033436
Status:
COMPLETED
Last Update Posted:
2013-09-20
First Post:
2002-04-09
Brief Title:
Radiation Therapy With or Without Carbogen and Niacinamide in Treating Patients With Bladder Cancer
Sponsor:
Mount Vernon Cancer Centre at Mount Vernon Hospital
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multicenter Randomized Trial of Radical Radiotherapy With Carbogen in the Radical Treatment of Locally Advanced Bladder Cancer
Status:
COMPLETED
Status Verified Date:
2002-12
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 such as carbogen and niacinamide may make tumor cells more sensitive to radiation therapy It is not yet known whether radiation therapy is more effective with or without carbogen and niacinamide in treating patients who have bladder cancer
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without carbogen and niacinamide in treating patients who have locally advanced bladder cancer
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without carbogen and niacinamide in treating patients who have locally advanced bladder cancer
Detailed Description:
OBJECTIVES
Compare the 6-month cystoscopic response in patients with locally advanced transitional cell carcinoma of the bladder treated with radical radiotherapy with or without radiosensitization with carbogen and niacinamide
Compare the local failure-free and overall disease-specific survival of patients treated with these regimens
Compare the treatment-related morbidity in particular acute and chronic bowel and bladder symptoms in patients treated with these regimens
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive radical radiotherapy once daily 5 days a week for 4-64 weeks Patients also receive oral niacinamide once daily 15-2 hours before initiation of each radiotherapy dose and carbogen through a closed breathing system face mask with a tight air seal or a mouthpiece with nasal clip once daily beginning 5 minutes before initiation and continuing until completion of each radiotherapy dose
Arm II Patients receive radiotherapy as in arm I Quality of life is assessed at baseline at 4 weeks at 3 6 and 12 months and then annually for 4 years
Patients are followed at 8 and 12 weeks at 6 9 and 12 months and then every 6 months for 4 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 330 patients 165 per treatment arm will be accrued for this study
Compare the 6-month cystoscopic response in patients with locally advanced transitional cell carcinoma of the bladder treated with radical radiotherapy with or without radiosensitization with carbogen and niacinamide
Compare the local failure-free and overall disease-specific survival of patients treated with these regimens
Compare the treatment-related morbidity in particular acute and chronic bowel and bladder symptoms in patients treated with these regimens
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive radical radiotherapy once daily 5 days a week for 4-64 weeks Patients also receive oral niacinamide once daily 15-2 hours before initiation of each radiotherapy dose and carbogen through a closed breathing system face mask with a tight air seal or a mouthpiece with nasal clip once daily beginning 5 minutes before initiation and continuing until completion of each radiotherapy dose
Arm II Patients receive radiotherapy as in arm I Quality of life is assessed at baseline at 4 weeks at 3 6 and 12 months and then annually for 4 years
Patients are followed at 8 and 12 weeks at 6 9 and 12 months and then every 6 months for 4 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 330 patients 165 per treatment arm 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 |
|---|---|---|---|
| EU-20051 | None | None | None |
| MTVERNHOSP-BCON | None | None | None |