A RANDOMIZED TRIAL OF RADICAL RADIOTHERAPY IN pT1G3 NXM0 BLADDER CANCER

OBJECTIVES:

• Compare the efficacy of adjuvant radical radiotherapy vs intravesical BCG or mitomycin vs observation alone after endoscopic resection in terms of the progression rate and survival of patients with stage I, grade 3 transitional cell carcinoma of the bladder.
• Determine the toxicity of radical radiotherapy in these patients.
• Determine the incidence of carcinoma in situ elsewhere in the bladder and its correlation with the subsequent clinical outcome of these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, extent of tumor (single tumor without carcinoma in situ (CIS) vs multiple tumors or CIS), and WHO performance status. Patients with a single tumor and no CIS are randomized to arm I or II. Patients with multiple tumors or CIS are randomized to arm II or III.

• Arm I: Patients undergo observation only.
• Arm II: Patients undergo radical radiotherapy 5 days a week for 6 weeks. Patients found to be node positive on CT scan may undergo pelvic irradiation and remain on study.
• Arm III: Patients receive intravesical BCG or mitomycin (at the discretion of the physician) weekly for 6-12 weeks.

Patients on arms I and III are followed at 3 months after randomization. All patients are followed at 6, 9, and 12 months and then annually thereafter.