Stage IV Bladder Cancer Clinical Trial
Official title:
Randomized Phase II Trial of Postoperative Adjuvant IMRT Following Cystectomy for pT3/T4 Urothelial Bladder Cancer
This randomized phase II trial studies the side effects and how well postoperative intensity modulated radiotherapy works after surgery in treating patients with urothelial bladder cancer. Radiation therapy uses high energy x-rays to kill tumor cells left behind in the pelvis after surgery. It is not yet known whether surgery followed by radiotherapy is more effective than surgery alone in treating patients with urothelial bladder cancer.
PRIMARY OBJECTIVE:
I. To evaluate the ability of postcystectomy adjuvant radiotherapy to safely reduce pelvic
tumor recurrence, defined as pelvic recurrence-free survival.
SECONDARY OBJECTIVES:
I. Evaluate increase in disease-free survival. II. Evaluate toxicity of adjuvant pelvic
radiotherapy.
OUTLINE: Patients are randomized to 1 of 2 treatment arms. Patients are stratified by
neoadjuvant preoperative or postoperative adjuvant chemotherapy.
After completion of study treatment, patients are followed up at 6 weeks, every 3 months for
1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually for 5 years.
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