Surgery With or Without Postoperative Intensity Modulated Radiation Therapy in Treating Patients With Urothelial Bladder Cancer

Official Title

Randomized Phase II Trial of Postoperative Adjuvant IMRT Following Cystectomy for pT3/T4 Urothelial Bladder Cancer

Summary:

This randomized phase II trial studies the side effects and how well postoperative intensity modulated radiation therapy works after surgery in treating patients with urothelial bladder cancer. Radiation therapy uses high energy x-rays to kill tumour cells left behind in the pelvis after surgery. It is not yet known whether surgery followed by radiation therapy is more effective than surgery alone in treating patients with urothelial bladder cancer.

Trial Description

Primary Outcome:

  • Pelvic recurrence-free survival (PRFS)
Secondary Outcome:
  • Disease free survival (DFS)
  • Incidence of acute radiation bowel toxicity, scored using the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0
  • Incidence of late radiation bowel toxicity, scored using the CTCAE v4.0
PRIMARY OBJECTIVE: I. To evaluate the ability of postcystectomy adjuvant radiation therapy to safely reduce pelvic tumour recurrence, defined as pelvic recurrence-free survival. SECONDARY OBJECTIVES:
I. Evaluate increase in disease-free survival. II. Evaluate toxicity of adjuvant pelvic radiation therapy. OUTLINE:

Patients are randomized to 1 of 2 treatment arms. Patients are stratified by neoadjuvant preoperative or postoperative adjuvant chemotherapy. ARM I: No radiation therapy. ARM II: Patients undergo radiation therapy (IMRT) 1.8 Gy, 5 days a week over 6 weeks for a total of 28 treatments and 50.4 Gy, in the absence of disease progression or unacceptable toxicity. IMRT starts within 14 days of registration if no postoperative adjuvant chemotherapy, otherwise within 14 days of the completion of the 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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society