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.
Primary Purpose: Treatment
Cora N. Sternberg, MD, FACP
Istituto Scientifico H. San Raffaele
United States: Federal Government