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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California, United States
Marin General Hospital
Greenbrae, California, United States
Los Angeles General Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Start Date
February 1, 2015
Primary Completion Date
February 1, 2017
Completion Date
February 1, 2017
Last Updated
November 20, 2025
14
ACTUAL participants
Intensity-Modulated Radiation Therapy
RADIATION
Lead Sponsor
NRG Oncology
Collaborators
NCT03375307
NCT05334069
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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