Randomized Phase II Trial of Postoperative Adjuvant IMRT Following Cystectomy for pT3/T4 Urothelial Bladder Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Stage III Bladder Cancer
- Sponsor
- NRG Oncology
- Enrollment
- 14
- Locations
- 127
- Primary Endpoint
- Pelvic Recurrence-free Survival (PRFS)
- Status
- Terminated
- Last Updated
- 5 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Pelvic Recurrence-free Survival (PRFS)
Time Frame: From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months
PRFS is defined as time free of pelvic recurrence or death, with patients who experience distant metastasis censored at the time of occurrence. Pelvic recurrence is specifically defined as soft tissue and /or lymph node tumor recurrence in the pelvis anywhere between the L5-S1 disc space superiorly and the pelvic floor inferiorly. This was to be determined on the basis of pelvic imaging (CT or MRI scan demonstrating soft tissue or nodal recurrence at least 1cm in linear dimension) or urethroscopy; biopsy was not required. PRFS was to be tested between arms in terms of a difference in cause-specific-hazards using the log-rank test and cumulative incidence of PRFS in the presence of competing risks was to be computed via cumulative incidence. Due to early termination with few patients, only counts of events have been calculated.
Secondary Outcomes
- Disease Free Survival (DFS)(From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months)
- Number of Patients With Bowel Toxicity(From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months)