NCT00003640

Transurethral Resection and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim
DRUG	cisplatin
DRUG	doxorubicin hydrochloride
DRUG	methotrexate
DRUG	vinblastine sulfate
PROCEDURE	surgical procedure
RADIATION	radiation therapy

Timeline

• Start date: 1998-09-01
• Primary completion: 2000-11-01
• First posted: 2004-05-20
• Last updated: 2012-03-06

Locations

1 site across 1 country: Italy