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

Phase 2

Terminated

Conditions: Stage III Bladder Cancer
Stage IV Bladder Cancer

Interventions: Radiation: Intensity-Modulated Radiation Therapy

Registration Number: NCT02316548

Lead Sponsor: NRG Oncology

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensity-modulated radiation therapy (IMRT)	Intensity-Modulated Radiation Therapy	Postoperative adjuvant intensity-modulated radiation therapy (IMRT).

Primary Outcome Measures

Name	Time	Method
Pelvic Recurrence-free Survival (PRFS)	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 Outcome Measures

Name	Time	Method
Disease Free Survival (DFS)	From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months	Disease free survival (DFS) is defined as the first occurrence of either: pelvic failure, distant metastasis, or death and was to be estimated by the Kaplan-Meier method and arms compared using the log-rank test. 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. Distant metastases is defined as any hematogenous metastases and/or lymph node metastases above the L5-S1 interspace, documented by imaging (CT and/or MRI and/or bone scans). Due to early termination with few patients, only counts of events have been calculated.
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	Adverse events (AE) evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Bowel toxicity= abdominal distension/pain, colitis, colonic fistula/ hemorrhage/obstruction/perforation/stenosis/ulcer, diarrhea, enterocolitis, fecal incontinence/gastrointestinal/fistula/pain, ileal fistula/hemorrhage/obstruction/perforation/stenosis/ulcer, Ileus, jejunal fistula/hemorrhage/obstruction/perforation/stenosis/ulcer, lower gastrointestinal hemorrhage, rectal fistula/hemorrhage/mucositis/necrosis/obstruction/pain/perforation/stenosis/ulcer, small intestinal mucositis/obstruction/perforation/stenosis/ulcer, vomiting. Highest grade adverse event per subject counted. Grade refers to AE severity and ranges from 1 to 5 with unique clinical descriptions of severity for each AE based on this general guideline: 1 Mild, 2 Moderate, 3 Severe, 4 Life-threatening or disabling, 5 Death related to AE.

Trial Locations

Locations (127): Los Angeles General Medical Center
🇺🇸
Los Angeles, California, United States
UCHealth University of Colorado Hospital
🇺🇸
Aurora, Colorado, United States
UCHealth Memorial Hospital Central
🇺🇸
Colorado Springs, Colorado, United States
Saint Luke's Cancer Institute - Boise
🇺🇸
Boise, Idaho, United States
Saint Luke's Cancer Institute - Fruitland
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Fruitland, Idaho, United States
Saint Luke's Cancer Institute - Meridian
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Meridian, Idaho, United States
Saint Luke's Cancer Institute - Nampa
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Nampa, Idaho, United States
Saint Luke's Cancer Institute - Twin Falls
🇺🇸
Twin Falls, Idaho, United States
OSF Saint Francis Radiation Oncology at Pekin
🇺🇸
Pekin, Illinois, United States
Springfield Memorial Hospital
🇺🇸
Springfield, Illinois, United States
McFarland Clinic - Ames
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Ames, Iowa, United States
Ascension Via Christi Hospitals Wichita
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Wichita, Kansas, United States
UofL Health Medical Center Northeast
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Louisville, Kentucky, United States
UM Upper Chesapeake Medical Center
🇺🇸
Bel Air, Maryland, United States
UM Baltimore Washington Medical Center/Tate Cancer Center
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Glen Burnie, Maryland, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Ann Arbor, Michigan, United States
Henry Ford Cancer Institute-Downriver
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Brownstown, Michigan, United States
Michigan Healthcare Professionals Clarkston
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Clarkston, Michigan, United States
Michigan Healthcare Professionals Farmington
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Farmington Hills, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital
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Livonia, Michigan, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
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Pontiac, Michigan, United States
Corewell Health William Beaumont University Hospital
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Royal Oak, Michigan, United States
Corewell Health Beaumont Troy Hospital
🇺🇸
Troy, Michigan, United States
Michigan Healthcare Professionals Troy
🇺🇸
Troy, Michigan, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
🇺🇸
Lebanon, New Hampshire, United States
ProMedica Flower Hospital
🇺🇸
Sylvania, Ohio, United States
Prisma Health Cancer Institute - Spartanburg
🇺🇸
Boiling Springs, South Carolina, United States
Prisma Health Cancer Institute - Faris
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Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside
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Greenville, South Carolina, United States
Prisma Health Cancer Institute - Greer
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Greer, South Carolina, United States
Prisma Health Cancer Institute - Seneca
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Seneca, South Carolina, United States
Dartmouth Cancer Center - North
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Saint Johnsbury, Vermont, United States
FHCC South Lake Union
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Seattle, Washington, United States
University of Washington Medical Center - Montlake
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Seattle, Washington, United States
University of Wisconsin Carbone Cancer Center - University Hospital
🇺🇸
Madison, Wisconsin, United States
Medical College of Wisconsin
🇺🇸
Milwaukee, Wisconsin, United States
AIS Cancer Center at San Joaquin Community Hospital
🇺🇸
Bakersfield, California, United States
Marin General Hospital
🇺🇸
Greenbrae, California, United States
USC / Norris Comprehensive Cancer Center
🇺🇸
Los Angeles, California, United States
Stanford Cancer Institute Palo Alto
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Palo Alto, California, United States
University of California Davis Comprehensive Cancer Center
🇺🇸
Sacramento, California, United States
Penrose-Saint Francis Healthcare
🇺🇸
Colorado Springs, Colorado, United States
Poudre Valley Hospital
🇺🇸
Fort Collins, Colorado, United States
Christiana Care Health System-Christiana Hospital
🇺🇸
Newark, Delaware, United States
Beebe Health Campus
🇺🇸
Rehoboth Beach, Delaware, United States
Moffitt Cancer Center
🇺🇸
Tampa, Florida, United States
Emory University Hospital Midtown
🇺🇸
Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute
🇺🇸
Atlanta, Georgia, United States
Emory Saint Joseph's Hospital
🇺🇸
Atlanta, Georgia, United States
Northeast Georgia Medical Center-Gainesville
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Gainesville, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
🇺🇸
Savannah, Georgia, United States
University of Chicago Comprehensive Cancer Center
🇺🇸
Chicago, Illinois, United States
Decatur Memorial Hospital
🇺🇸
Decatur, Illinois, United States
Loyola University Medical Center
🇺🇸
Maywood, Illinois, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
🇺🇸
Peoria, Illinois, United States
OSF Saint Francis Medical Center
🇺🇸
Peoria, Illinois, United States
Carle Cancer Center
🇺🇸
Urbana, Illinois, United States
Radiation Oncology Associates PC
🇺🇸
Fort Wayne, Indiana, United States
Parkview Hospital Randallia
🇺🇸
Fort Wayne, Indiana, United States
Goshen Center for Cancer Care
🇺🇸
Goshen, Indiana, United States
Memorial Regional Cancer Center Day Road
🇺🇸
Mishawaka, Indiana, United States
Memorial Hospital of South Bend
🇺🇸
South Bend, Indiana, United States
University of Kansas Cancer Center
🇺🇸
Kansas City, Kansas, United States
Lawrence Memorial Hospital
🇺🇸
Lawrence, Kansas, United States
Norton Hospital Pavilion and Medical Campus
🇺🇸
Louisville, Kentucky, United States
Maine Medical Center- Scarborough Campus
🇺🇸
Scarborough, Maine, United States
University of Maryland/Greenebaum Cancer Center
🇺🇸
Baltimore, Maryland, United States
Central Maryland Radiation Oncology in Howard County
🇺🇸
Columbia, Maryland, United States
Massachusetts General Hospital Cancer Center
🇺🇸
Boston, Massachusetts, United States
Lahey Hospital and Medical Center
🇺🇸
Burlington, Massachusetts, United States
Henry Ford Macomb Hospital-Clinton Township
🇺🇸
Clinton Township, Michigan, United States
Henry Ford Hospital
🇺🇸
Detroit, Michigan, United States
Regions Hospital
🇺🇸
Saint Paul, Minnesota, United States
University of Mississippi Medical Center
🇺🇸
Jackson, Mississippi, United States
Siteman Cancer Center at West County Hospital
🇺🇸
Creve Coeur, Missouri, United States
Washington University School of Medicine
🇺🇸
Saint Louis, Missouri, United States
Missouri Baptist Medical Center
🇺🇸
Saint Louis, Missouri, United States
Siteman Cancer Center at Saint Peters Hospital
🇺🇸
Saint Peters, Missouri, United States
Billings Clinic Cancer Center
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Billings, Montana, United States
Nebraska Methodist Hospital
🇺🇸
Omaha, Nebraska, United States
Renown Regional Medical Center
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Reno, Nevada, United States
Virtua Memorial
🇺🇸
Mount Holly, New Jersey, United States
Robert Wood Johnson University Hospital Somerset
🇺🇸
Somerville, New Jersey, United States
University of New Mexico Cancer Center
🇺🇸
Albuquerque, New Mexico, United States
New Mexico Oncology Hematology Consultants
🇺🇸
Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
🇺🇸
Buffalo, New York, United States
University of Rochester
🇺🇸
Rochester, New York, United States
Stony Brook University Medical Center
🇺🇸
Stony Brook, New York, United States
Dickstein Cancer Treatment Center
🇺🇸
White Plains, New York, United States
University of Oklahoma Health Sciences Center
🇺🇸
Oklahoma City, Oklahoma, United States
Bay Area Hospital
🇺🇸
Coos Bay, Oregon, United States
University of Pennsylvania/Abramson Cancer Center
🇺🇸
Philadelphia, Pennsylvania, United States
Reading Hospital
🇺🇸
West Reading, Pennsylvania, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
Saint Francis Cancer Center
🇺🇸
Greenville, South Carolina, United States
Spartanburg Medical Center
🇺🇸
Spartanburg, South Carolina, United States
Vanderbilt University/Ingram Cancer Center
🇺🇸
Nashville, Tennessee, United States
UT Southwestern/Simmons Cancer Center-Dallas
🇺🇸
Dallas, Texas, United States
University of Texas Medical Branch
🇺🇸
Galveston, Texas, United States
UTMB Cancer Center at Victory Lakes
🇺🇸
League City, Texas, United States
Logan Regional Hospital
🇺🇸
Logan, Utah, United States
Intermountain Medical Center
🇺🇸
Murray, Utah, United States
McKay-Dee Hospital Center
🇺🇸
Ogden, Utah, United States
Utah Cancer Specialists-Salt Lake City
🇺🇸
Salt Lake City, Utah, United States
Huntsman Cancer Institute/University of Utah
🇺🇸
Salt Lake City, Utah, United States
West Virginia University Healthcare
🇺🇸
Morgantown, West Virginia, United States
Aurora Cancer Care-Grafton
🇺🇸
Grafton, Wisconsin, United States
Aurora BayCare Medical Center
🇺🇸
Green Bay, Wisconsin, United States
Aurora Cancer Care-Kenosha South
🇺🇸
Kenosha, Wisconsin, United States
Aurora Saint Luke's Medical Center
🇺🇸
Milwaukee, Wisconsin, United States
Aurora Sinai Medical Center
🇺🇸
Milwaukee, Wisconsin, United States
Vince Lombardi Cancer Clinic - Oshkosh
🇺🇸
Oshkosh, Wisconsin, United States
Vince Lombardi Cancer Clinic-Sheboygan
🇺🇸
Sheboygan, Wisconsin, United States
Aurora Medical Center in Summit
🇺🇸
Summit, Wisconsin, United States
Vince Lombardi Cancer Clinic-Two Rivers
🇺🇸
Two Rivers, Wisconsin, United States
Aurora West Allis Medical Center
🇺🇸
West Allis, Wisconsin, United States
Tom Baker Cancer Centre
🇨🇦
Calgary, Alberta, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
🇨🇦
Hamilton, Ontario, Canada
London Regional Cancer Program
🇨🇦
London, Ontario, Canada
Ottawa Hospital and Cancer Center-General Campus
🇨🇦
Ottawa, Ontario, Canada
Odette Cancer Centre- Sunnybrook Health Sciences Centre
🇨🇦
Toronto, Ontario, Canada
CHUM - Hopital Notre-Dame
🇨🇦
Montreal, Quebec, Canada
McGill University Department of Oncology
🇨🇦
Montreal, Quebec, Canada
Jewish General Hospital
🇨🇦
Montreal, Quebec, Canada
Allan Blair Cancer Centre
🇨🇦
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
🇨🇦
Saskatoon, Saskatchewan, Canada
Rabin Medical Center
🇮🇱
Petach Tikva, Israel