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Radiation Therapy, Chemotherapy, or Observation in Treating Patients With Bladder Cancer Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Radiation Therapy, Chemotherapy, or Observation in Treating Patients With Bladder Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Radiation Therapy, Chemotherapy, or Observation in Treating Patients With Bladder Cancer Clinical research trials and Radiation Therapy, Chemotherapy, or Observation in Treating Patients With Bladder Cancer healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Radiation Therapy, Chemotherapy, or Observation in Treating Patients With Bladder Cancer. Radiation Therapy, Chemotherapy, or Observation in Treating Patients With Bladder Cancer Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Radiation Therapy, Chemotherapy, or Observation in Treating Patients With Bladder Cancer clinical trial. Human subjects often obtain the finest healthcare possible for their Radiation Therapy, Chemotherapy, or Observation in Treating Patients With Bladder Cancer condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Radiation Therapy, Chemotherapy, or Observation in Treating Patients With Bladder Cancer  Radiation Therapy, Chemotherapy, or Observation in Treating Patients With Bladder Cancer
Radiation Therapy, Chemotherapy, or Observation in Treating Patients With Bladder Cancer
For Condition: stage 1 bladder cancer,transitional cell carcinoma of the bladder
Status: No longer recruiting
Sponsor(s): Medical Research Council ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StephenHarland, Study Chair, Middlesex Hospital - Meyerstein Institute
Middlesex Hospital- Meyerstein Institute
London, England, WIT 3AA
United Kingdom
Additional Information:
Study ID Numbers: CDR0000077404; MRC-BS06,EU-91019
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002490
Other Transitional Cell Carcinoma Of The Bladder Studies:
1. Oxaliplatin in Treating Patients With Metastatic Bladder Cancer
2. Radiation Therapy With or Without Carbogen and Niacinamide in Treating Patients With Bladder Cancer
3. High-Dose Multivitamins Compared to a Placebo in Preventing the Recurrence of Cancer in Patients With Early Stage Bladder Cancer
4. Radiation Therapy and Chemotherapy Following Surgery in Treating Patients With Stage II or Stage III Bladder Cancer
5. Pemetrexed Disodium in Treating Patients With Locally Advanced or Metastatic Recurrent Cancer of the Urothelium
Related Studies:
Other transitional cell carcinoma of the bladder Clinical Trials
Other England Clinical Trials
Other London Clinical Trials
Radiation Therapy, Chemotherapy, or Observation in Treating Patients With Bladder Cancer
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