Surgery With or Without Postoperative Intensity Modulated Radiation Therapy in Treating Patients With Urothelial Bladder Cancer
|Stage III Bladder Cancer Stage IV Bladder Cancer||Other: No radiation Radiation: Intensity-Modulated Radiation Therapy|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Randomized Phase II Trial of Postoperative Adjuvant IMRT Following Cystectomy for pT3/T4 Urothelial Bladder Cancer|
- Pelvic recurrence-free survival (PRFS) [ Time Frame: From randomization to 12 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 will 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 is not required.
- Disease free survival (DFS) [ Time Frame: Up to 10 years ]Disease free survival (DFS) is defined as the first occurrence of either: pelvic failure, distant metastasis, or death
- Incidence of acute radiation bowel toxicity, scored using the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 [ Time Frame: From of the start of radiotherapy up to 90 days ]Bowel toxicity will be evaluated using the CTCAE version 4.0
- Incidence of late radiation bowel toxicity, scored using the CTCAE v4.0 [ Time Frame: From 91 days from the start of radiotherapy up to 10 years ]Bowel toxicity will be evaluated using the CTCAE version 4.0
|Actual Study Start Date:||February 2015|
|Study Completion Date:||February 1, 2017|
|Primary Completion Date:||February 1, 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Arm I (No radiation)
Patients do not receive radiation.
Other: No radiation
No radiation is received by the patient.
Experimental: Arm II (Post-op Adjuvant IMRT)
Patients receive Intensity-Modulated Radiation Therapy (IMRT).
Radiation: Intensity-Modulated Radiation Therapy
Undergo radiotherapy (IMRT)
Other Name: IMRT
I. To evaluate the ability of postcystectomy adjuvant radiotherapy to safely reduce pelvic tumor recurrence, defined as pelvic recurrence-free survival.
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.
ARM I: No radiotherapy.
ARM II: Patients undergo radiotherapy (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02316548
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|Principal Investigator:||Libni Eapen||NRG Oncology|