A RANDOMIZED TRIAL OF RADICAL RADIOTHERAPY IN pT1G3 NXM0 BLADDER CANCER
- 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.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Stephen J. Harland, MD
University College London Hospitals
United States: Federal Government