A RANDOMIZED TRIAL OF RADICAL RADIOTHERAPY IN pT1G3 NXM0 BLADDER CANCER
N/A
N/A
Both
Bladder Cancer
Trial Information
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.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Stephen J. Harland, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University College London Hospitals
Authority:
United States: Federal Government
Study ID:
CDR0000077404
NCT ID:
NCT00002490
Start Date:
September 1991
Completion Date:
Related Keywords:
- Bladder Cancer
- stage I bladder cancer
- transitional cell carcinoma of the bladder
- Urinary Bladder Neoplasms
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