Bladder Cancer Clinical Trial
Official title:
A Multicenter Randomized Trial of Radical Radiotherapy With Carbogen in the Radical Treatment of Locally Advanced 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.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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