Radiation Therapy With or Without Carbogen and Niacinamide in Treating Patients With Bladder Cancer
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.
Dietary Supplement: niacinamide
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Multicenter Randomized Trial of Radical Radiotherapy With Carbogen in the Radical Treatment of Locally Advanced Bladder Cancer|
- Cystoscopic response at 6 months after initiation radiotherapy [ Designated as safety issue: No ]
- Local failure-free survival [ Designated as safety issue: No ]
- Overall disease-specific survival [ Designated as safety issue: No ]
- Treatment related morbidity (i.e., acute and chronic bowel and bladder symptoms) [ Designated as safety issue: No ]
- Quality of life as assessed by FACT-BI scale at baseline, week 4, 3 months, 6 months, 12 months, and yearly thereafter for 5 years [ Designated as safety issue: No ]
|Study Start Date:||October 2000|
|Study Completion Date:||November 2008|
- 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 4-6.4 weeks. Patients also receive oral niacinamide once daily 1.5-2 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.
|Sussex Cancer Centre at Royal Sussex County Hospital|
|Brighton, England, United Kingdom, BN2 5BF|
|Bristol Haematology and Oncology Centre|
|Bristol, England, United Kingdom, BS2 8ED|
|Kent and Canterbury Hospital|
|Canterbury, England, United Kingdom, CT2 3NG|
|Derbyshire Royal Infirmary|
|Derby, England, United Kingdom, DE1 2QY|
|Ipswich Hospital NHS Trust|
|Ipswich, England, United Kingdom, IP4 5PD|
|Cookridge Hospital at Leeds Teaching Hospital NHS Trust|
|Leeds, England, United Kingdom, LS16 6QB|
|Christie Hospital NHS Trust|
|Manchester, England, United Kingdom, M20 4BX|
|Clatterbridge Centre for Oncology NHS Trust|
|Merseyside, England, United Kingdom, CH63 4JY|
|Northern Centre for Cancer Treatment at Newcastle General Hospital|
|Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE|
|Mount Vernon Cancer Centre at Mount Vernon Hospital|
|Northwood, England, United Kingdom, HA6 2RN|
|Nottingham City Hospital NHS Trust|
|Nottingham, England, United Kingdom, NG5 1PB|
|Romford, England, United Kingdom, RM7 OBE|
|Cancer Research Centre at Weston Park Hospital|
|Sheffield, England, United Kingdom, S1O 2SJ|
|Velindre Cancer Center at Velindre Hospital|
|Cardiff, Wales, United Kingdom, CF14 2TL|
|Study Chair:||Peter J. Hoskin, MD||Mount Vernon Cancer Centre at Mount Vernon Hospital|