Trial Information

A Multicenter Randomized Trial of Radical Radiotherapy With Carbogen in the Radical Treatment of Locally Advanced Bladder Cancer

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.