Bladder Cancer Clinical Trial
Official title:
A RANDOMIZED TRIAL OF RADICAL RADIOTHERAPY IN pT1G3 NXM0 BLADDER CANCER
Verified date | June 2001 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in
chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
die. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not
known whether receiving either radiation therapy, chemotherapy, or observation is more
effective for cancer of the bladder.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy,
chemotherapy, or observation following tumor surgery in treating patients who have bladder
cancer.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Middlesex Hospital- Meyerstein Institute | London | England |
Lead Sponsor | Collaborator |
---|---|
Medical Research Council |
United Kingdom,
Harland SJ: A randomised trial of radical radiotherapy in pT1G3 NXM0 bladder cancer (MRC BS06). [Abstract] J Clin Oncol 23 (Suppl 16): A-4505, 379s, 2005.
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