Trial Information

Summary: A multicenter trial of adjuvant chemotherapy in organ-confined Bladder Cancer based on p53 status

This prospective randomized trial will compare the recurrence-free and overall survival of those patients demonstrating alternations in the p53 gene who are treated with MVAC to patients with tumors demonstrating p53 alterations in p53 who are observed to patients with no p53 alterations who are also observed, allow for the examination of expression p53 and other genes, particularly RB, p21 and p16 involved in cell cycle regulation that may be involved in the response to chemotherapy, and to provide a biorcpository of paraffin embedded tumor tissue for future studies of genetic markers of tumor progression.

Patient Inclusion/Exclusion Criteria:

Patients who have undergone a radical cystectomy and bilateral pelvic lymphadenopathy with pathologic stage from the definitive cystectomy specimen of P1, P2, P3a, NO, MO transitional cell carcinoma with or without squamous/glandular differentiation (adenocarcinoma, squamous cell carcinoma, small cell carcinoma specifically excluded). Patients must register for protocol within 6 weeks from the date of surgery.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.