• 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 ]
  

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 4-6.4 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.