At a glance
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A Phase II Protocol for Patients With Stage T1 Bladder Cancer to Evaluate Selective Bladder Preserving Treatment by Radiation Therapy Concurrent With Radiosensitizing Chemotherapy Following a Thorough Transurethral Surgical Re-Staging
In Brief
A Phase 2 clinical trial evaluating cisplatin, 5-fluorouracil, and 2 other interventions for Bladder Cancer. Completed, enrolled 37 participants across 13 sites.
Detailed Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, mitomycin C, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cisplatin may kill more tumor cells. PURPOSE: This phase II trial is studying how well radiation therapy given together with chemotherapy works in treating patients with stage I bladder cancer.
Study Details
Timeline
Interventions
60-minute intravenous (IV) infusion of 15 mg/m\^2 on days 1, 2, 3, 15, 16, 17, 29, 30, and 31 of radiation treatment.
Continuous IV infusion of 500 mg/m\^2/24 hrs for 5 consecutive days during weeks 1 and 4 of radiation treatment.
IV bolus dose of 12 mg/m\^2 on day 1 of radiation treatment.
Total dose to the gross bladder volume of 61.2 Gy as 34 daily fractions 5 days/week, for approximately 7 weeks.