A Feasibility Study of Thorough Transurethral Resection (TURB) and Escalated Dose M-VAC Chemotherapy as Primary Treatment of T2-T3a, N0-Nx, M0 Transitional Cell Carcinoma of the Bladder, With the Intention of Bladder Preservation
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N/A
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Bladder Cancer
Trial Information
A Feasibility Study of Thorough Transurethral Resection (TURB) and Escalated Dose M-VAC Chemotherapy as Primary Treatment of T2-T3a, N0-Nx, M0 Transitional Cell Carcinoma of the Bladder, With the Intention of Bladder Preservation
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.
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.
Inclusion 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
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
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Cora N. Sternberg, MD, FACP
Investigator Role:
Study Chair
Investigator Affiliation:
Istituto Scientifico H. San Raffaele
Authority:
United States: Federal Government
Study ID:
EORTC-30971
NCT ID:
NCT00003640
Start Date:
September 1998
Completion Date:
Related Keywords:
- Bladder Cancer
- stage II bladder cancer
- stage III bladder cancer
- transitional cell carcinoma of the bladder
- Urinary Bladder Neoplasms
- Carcinoma, Transitional Cell
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