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Transurethral Resection and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Transurethral Resection and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Transurethral Resection and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer Clinical research trials and Transurethral Resection and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Transurethral Resection and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer. Transurethral Resection and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Transurethral Resection and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Transurethral Resection and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Transurethral Resection and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer  Transurethral Resection and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
Transurethral Resection and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
For Condition: transitional cell carcinoma of the bladder,stage 3 bladder cancer,childhood kidney/urinary cancer,stage 2 bladder cancer
Status: No longer recruiting
Sponsor(s): EORTC Genito-Urinary Tract Cancer Cooperative Group ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combination chemotherapy combined with transurethral resection may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of transurethral resection plus combination chemotherapy in treating patients who have stage II or stage III bladder cancer.
Details: OBJECTIVES: I. Determine the percentage of patients with transitional cell carcinoma of the bladder who are disease free or who have minimal disease 3 months after thorough transurethral resection (TURB) and escalated dose methotrexate/vinblastine/doxorubicin/cisplatin (M-VAC) chemotherapy. II. Evaluate the combination of thorough TURB and escalated dose M-VAC followed by radiotherapy with respect to bladder preservation for patients who respond to neoadjuvant chemotherapy. III. Evaluate the proportion of patients remaining disease free and not requiring cystectomy at 1 year. IV. Evaluate the feasibility and morbidity of this treatment schedule in multiple institutions applied by urologists of possibly varying endoscopic ability. PROTOCOL OUTLINE: This is a multicenter study. Patients undergo a local transurethral resection. Patients then receive methotrexate IV on day 1, followed by vinblastine IV, doxorubicin IV, and cisplatin IV on day 2. Filgrastim (G-CSF) is administered on days 4-10. Chemotherapy is repeated every 14 days for 3 courses. After the end of chemotherapy, patients undergo another local transurethral resection in order to define response to treatment. Patients with minimal or no disease are treated with radiotherapy. Patients who still have disease undergo a cystectomy. Patients are followed every 3 months for the first 2 years, and then every 6 months until death. PROJECTED ACCRUAL: A total of 29-73 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Transitional cell carcinoma of the bladder with biopsy proven muscle invasion suitable for resection leaving no residual visible or palpable tumor mass; Unifocal; No greater than 5 cm; Stages II and III (T2-T3a, N0-NX, M0) - No prior treatment for bladder cancer other than endoscopic resection, intravesical chemotherapy, or intravesical immunotherapy --Prior/Concurrent Therapy-- - Biologic therapy: See Disease Characteristics - Chemotherapy: See Disease Characteristics; No prior systemic chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy to the bladder - Surgery: See Disease Characteristics; No prior partial cystectomy; Prior transurethral resection of the bladder allowed --Patient Characteristics-- - Age: Not specified - Performance status: WHO 0-1 - Life expectancy: Not specified - Hematopoietic: WBC at least 3,500/mm3; Platelet count at least 120,000/mm3 - Hepatic: Bilirubin normal SGOT/SGPT normal - Renal: GFR at least 50 mL/min - Cardiovascular: Normal cardiac function (i.e., no New York Heart Association class II-IV) - Other: Normal auditory function; No second primary malignant tumor except basal cell carcinoma of the skin; Fit for cisplatin containing combination chemotherapy, radical radiotherapy, or cystectomy; No active infections; Not pregnant or nursing; No concurrent illness that significantly affects clinical assessments
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CoraSternberg, Study Chair, EORTC Genito-Urinary Tract Cancer Cooperative Group
San Raffaele Hospital
Rome, , 00144
Italy
Additional Information:
Study ID Numbers: CDR0000066725; EORTC-30971
Study Start Date: September 1998
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003640
Other Stage 3 Bladder Cancer Studies:
1. Fluorouracil in Treating Patients With Recurrent or Metastatic Bladder Cancer
2. Arsenic Trioxide in Treating Patients With Metastatic Kidney Cancer
3. Transurethral Resection and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
4. Combination Chemotherapy in Treating Patients With Bladder Cancer
Related Studies:
Other stage 3 bladder cancer Clinical Trials
Other Clinical Trials
Other Rome Clinical Trials
Transurethral Resection and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
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