A RANDOMIZED TRIAL OF RADICAL RADIOTHERAPY IN pT1G3 NXM0 BLADDER CANCER
BCG vaccine
+ mitomycin C
+ radiation therapy
Urogenital Diseases+8
+ Urinary Bladder Diseases
+ Female Urogenital Diseases and Pregnancy Complications
Treatment Study
Summary
Study start date: September 1, 1991
Actual date on which the first participant was enrolled.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. PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Diagnosis of transitional cell carcinoma of the bladder Stage T1 Nx M0, grade 3 disease No muscle invasion at base of tumor Diagnosis of this stage made within the past 6 months Earlier diagnosis of tumors with lower stage or grade allowed No history of higher stage urothelial tumors Presence of partial involvement of bladder with carcinoma in situ (CIS) or asymptomatic widespread CIS allowed No widespread CIS causing severe symptoms Prior complete transurethral resection of tumor with deep biopsy of underlying bladder wall required Disease currently amenable to adjuvant radiotherapy, followed by cystoscopy with biopsies PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other prior or concurrent malignancy except nonmelanomatous skin cancer or cervical intraepithelial neoplasia PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior adjuvant treatment with intravesical BCG Chemotherapy: No more than 1 prior adjuvant treatment with intravesical chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Diathermic removal of associated small papillary growths allowed
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Middlesex Hospital- Meyerstein Institute
London, United KingdomOpen Middlesex Hospital- Meyerstein Institute in Google Maps