Bladder cancer radiation trial halted early

NCT ID NCT02316548

Disease control Sponsor: NRG Oncology Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether giving radiation therapy after bladder removal surgery could help prevent cancer from coming back in the pelvis. It included 14 people with advanced bladder cancer. The trial was stopped early, so we don't have clear answers on whether the radiation helped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

14 people

The number who actually took part.

Started

Feb 2015

Finished

Feb 2017

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria (A patient cannot be considered eligible for this study unless ALL of the following conditions are met.): * Initial histological diagnosis of muscle invasive urothelial carcinoma * Patients must have undergone a radical cystectomy (reconstructed urinary diversion may be non-continent diversions (eg, ileal conduits) or continent non-orthotopic catheterizable diversions (eg, Indiana pouch) or continent orthotopic diversions (eg, Studer pouch or neobladder)for urothelial bladder carcinoma within 105 days prior to registration. Final cystectomy pathology must be either pure urothelial carcinoma or dominant urothelial carcinoma with admixture of other histologies excluding small cell variants. * Neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy for the bladder cancer is permitted; however, all patients, even those who will receive adjuvant chemotherapy, must be registered within 105 days after completing cystectomy regardless of whether adjuvant chemotherapy has started. Patients who will be receiving adjuvant (postoperative) chemotherapy will be randomized within 28 days of completing that chemotherapy. * Patients with the following pTNM stages per the American Joint Committee on Cancer (AJCC) 7th ed. are eligible: * pT3apN0; pN1; pN2 provided less than 10 nodes dissected and/or positive surgical margins * pT3bpN0; pN1; pN2 * pT4apN0; pN1; pN2 * pT4bpN0; pN1; pN2 * Appropriate stage for study entry based on the following diagnostic workup: * History/physical examination =\< 45 days prior to registration; * CT or MRI or positron emission tomography(PET)-CT that includes chest, abdomen and pelvis should be performed for initial radiological staging. This may be performed pre- or post-surgery ≤ 90 days prior to registration except in patients getting postoperative adjuvant chemotherapy, who will require CT, MRI or PET-CT including the chest and abdomen and pelvis no more than 30 days prior to registration. Imaging performed postoperatively should show no evidence of residual disease. * Age \>=18 * Zubrod performance status 0-2 =\< 45 days prior to registration * Complete blood count (CBC)/differential obtained ≤ 14 days prior to registration with adequate bone marrow function defined as follows: * Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3 * Platelets \>= 100,000 cells/mm\^3 * Hemoglobin \>= 8.0 g/dl (NOTE: the use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 8.0 g/dl is acceptable) * The patient must provide study-specific informed consent prior to study entry * The patient must provide study-specific informed consent prior to study entry. Exclusion Criteria (Patients with any of the following conditions are NOT eligible for this study.): * Definitive clinical or radiologic evidence of metastatic disease; pN3 disease is not allowed (positive common iliac node). * Prior invasive solid tumor or hematological malignancy (except non-melanomatous skin cancer and incidentally discovered prostate cancer at time of cystoprostatectomy) unless disease free for a minimum of 3 years * Prior radiotherapy to the pelvis * Patients with a history of inflammatory bowel disease * Patients who have required any treatment (medical or surgical) for bowel obstruction prior to diagnosis of bladder cancer or who have required surgical treatment for bowel obstruction after the cystectomy * Severe, active co-morbidity defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; * Transmural myocardial infarction within the last 6 months; * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; * Severe hepatic disease, defined as a diagnosis of Child-Pugh Class B or C hepatic disease; * HIV positive with CD4 count \< 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol. * Other major medical illness which requires hospitalization or precludes study therapy at the time of registration. * Women who are breastfeeding

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

bladder transitional cell carcinoma stage IVb bladder cancer Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stage III bladder cancer Stage IV bladder cancer

Contacts and locations

Locations

AIS Cancer Center at San Joaquin Community Hospital

Bakersfield, California, 93301, United States
Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada
Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5G2, Canada
Ascension Via Christi Hospitals Wichita

Wichita, Kansas, 67214, United States
Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311, United States
Aurora Cancer Care-Grafton

Grafton, Wisconsin, 53024, United States
Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, 53142, United States
Aurora Medical Center in Summit

Summit, Wisconsin, 53066, United States
Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States
Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53233, United States
Aurora West Allis Medical Center

West Allis, Wisconsin, 53227, United States
Bay Area Hospital

Coos Bay, Oregon, 97420, United States
Beebe Health Campus

Rehoboth Beach, Delaware, 19971, United States
Billings Clinic Cancer Center

Billings, Montana, 59101, United States
CHUM - Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada
Carle Cancer Center

Urbana, Illinois, 61801, United States
Central Maryland Radiation Oncology in Howard County

Columbia, Maryland, 21044, United States
Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States
Corewell Health Beaumont Troy Hospital

Troy, Michigan, 48085, United States
Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073, United States
Dartmouth Cancer Center - North

Saint Johnsbury, Vermont, 05819, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, United States
Decatur Memorial Hospital

Decatur, Illinois, 62526, United States
Dickstein Cancer Treatment Center

White Plains, New York, 10601, United States
Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States
Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States
Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States
Goshen Center for Cancer Care

Goshen, Indiana, 46526, United States
Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, 48183, United States
Henry Ford Hospital

Detroit, Michigan, 48202, United States
Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, 48038, United States
Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States
Intermountain Medical Center

Murray, Utah, 84107, United States
Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada
Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada
Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States
Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, 31405, United States
Logan Regional Hospital

Logan, Utah, 84321, United States
London Regional Cancer Program

London, Ontario, N6A 4L6, Canada
Los Angeles General Medical Center

Los Angeles, California, 90033, United States
Loyola University Medical Center

Maywood, Illinois, 60153, United States
MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, 04074, United States
Marin General Hospital

Greenbrae, California, 94904, United States
Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States
McFarland Clinic - Ames

Ames, Iowa, 50010, United States
McGill University Department of Oncology

Montreal, Quebec, H2W 1S6, Canada
McKay-Dee Hospital Center

Ogden, Utah, 84403, United States
Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Medical University of South Carolina

Charleston, South Carolina, 29425, United States
Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States
Memorial Regional Cancer Center Day Road

Mishawaka, Indiana, 46545, United States
Michigan Healthcare Professionals Clarkston

Clarkston, Michigan, 48346, United States
Michigan Healthcare Professionals Farmington

Farmington Hills, Michigan, 48334, United States
Michigan Healthcare Professionals Troy

Troy, Michigan, 48098, United States
Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States
Moffitt Cancer Center

Tampa, Florida, 33612, United States
Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States
New Mexico Oncology Hematology Consultants

Albuquerque, New Mexico, 87109, United States
Northeast Georgia Medical Center-Gainesville

Gainesville, Georgia, 30501, United States
Norton Hospital Pavilion and Medical Campus

Louisville, Kentucky, 40202, United States
OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States
OSF Saint Francis Radiation Oncology at Pekin

Pekin, Illinois, 61554, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center

Peoria, Illinois, 61615, United States
Odette Cancer Centre- Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada
Ottawa Hospital and Cancer Center-General Campus

Ottawa, Ontario, K1H 8L6, Canada
Parkview Hospital Randallia

Fort Wayne, Indiana, 46805, United States
Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, 80907, United States
Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States
Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States
Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650, United States
Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672, United States
Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316, United States
ProMedica Flower Hospital

Sylvania, Ohio, 43560, United States
Rabin Medical Center

Petah Tikva, 49100, Israel
Radiation Oncology Associates PC

Fort Wayne, Indiana, 46804, United States
Reading Hospital

West Reading, Pennsylvania, 19611, United States
Regions Hospital

Saint Paul, Minnesota, 55101, United States
Renown Regional Medical Center

Reno, Nevada, 89502, United States
Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, 08876, United States
Roswell Park Cancer Institute

Buffalo, New York, 14263, United States
Saint Francis Cancer Center

Greenville, South Carolina, 29607, United States
Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712, United States
Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, 83619, United States
Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, 83642, United States
Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, 83687, United States
Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, 83301, United States
Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada
Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141, United States
Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States
Springfield Memorial Hospital

Springfield, Illinois, 62781, United States
Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States
Stony Brook University Medical Center

Stony Brook, New York, 11794, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106, United States
Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341, United States
Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154, United States
UCHealth Memorial Hospital Central

Colorado Springs, Colorado, 80909, United States
UCHealth University of Colorado Hospital

Aurora, Colorado, 80045, United States
UM Baltimore Washington Medical Center/Tate Cancer Center

Glen Burnie, Maryland, 21061, United States
UM Upper Chesapeake Medical Center

Bel Air, Maryland, 21014, United States
USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States
UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States
UTMB Cancer Center at Victory Lakes

League City, Texas, 77573, United States
University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States
University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States
University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States
University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States
University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States
University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States
University of Rochester

Rochester, New York, 14642, United States
University of Texas Medical Branch

Galveston, Texas, 77555-0565, United States
University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States
University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792, United States
UofL Health Medical Center Northeast

Louisville, Kentucky, 40245, United States
Utah Cancer Specialists-Salt Lake City

Salt Lake City, Utah, 84106, United States
Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States
Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, 54904, United States
Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, 53081, United States
Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, 54241, United States
Virtua Memorial

Mount Holly, New Jersey, 08060, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States
West Virginia University Healthcare

Morgantown, West Virginia, 26506, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.