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Stage III Bladder CancerPhase 2NCT02316548

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

A Phase 2 study testing Intensity-Modulated Radiation Therapy in people with Stage III Bladder Cancer and Stage IV Bladder Cancer, run by NRG Oncology at 127 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Intensity-Modulated Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
127 sitesin 3 countries
Study dates
Feb 2015to 1 Feb 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

127 sites in 3 countries.

127 sites in 3 countries

United States116 sites

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • New Mexico Oncology Hematology Consultants

    Albuquerque, New Mexico, 87109

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

  • AIS Cancer Center at San Joaquin Community Hospital

    Bakersfield, California, 93301

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • UM Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Henry Ford Cancer Institute-Downriver

    Brownstown, Michigan, 48183

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

  • Michigan Healthcare Professionals Clarkston

    Clarkston, Michigan, 48346

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan, 48038

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

  • Central Maryland Radiation Oncology in Howard County

    Columbia, Maryland, 21044

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Michigan Healthcare Professionals Farmington

    Farmington Hills, Michigan, 48334

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Radiation Oncology Associates PC

    Fort Wayne, Indiana, 46804

  • Parkview Hospital Randallia

    Fort Wayne, Indiana, 46805

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

  • Northeast Georgia Medical Center-Gainesville

    Gainesville, Georgia, 30501

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • UM Baltimore Washington Medical Center/Tate Cancer Center

    Glen Burnie, Maryland, 21061

  • Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Marin General Hospital

    Greenbrae, California, 94904

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • UTMB Cancer Center at Victory Lakes

    League City, Texas, 77573

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • Logan Regional Hospital

    Logan, Utah, 84321

  • Los Angeles General Medical Center

    Los Angeles, California, 90033

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Norton Hospital Pavilion and Medical Campus

    Louisville, Kentucky, 40202

  • UofL Health Medical Center Northeast

    Louisville, Kentucky, 40245

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

  • Memorial Regional Cancer Center Day Road

    Mishawaka, Indiana, 46545

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506

  • Virtua Memorial

    Mount Holly, New Jersey, 08060

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho, 83687

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, 94304

  • OSF Saint Francis Radiation Oncology at Pekin

    Pekin, Illinois, 61554

  • OSF Saint Francis Radiation Oncology at Peoria Cancer Center

    Peoria, Illinois, 61615

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • University of Rochester

    Rochester, New York, 14642

  • Corewell Health William Beaumont University Hospital

    Royal Oak, Michigan, 48073

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Dartmouth Cancer Center - North

    Saint Johnsbury, Vermont, 05819

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • Utah Cancer Specialists-Salt Lake City

    Salt Lake City, Utah, 84106

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia, 31405

  • MaineHealth Maine Medical Center- Scarborough

    Scarborough, Maine, 04074

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672

  • Vince Lombardi Cancer Clinic-Sheboygan

    Sheboygan, Wisconsin, 53081

  • Robert Wood Johnson University Hospital Somerset

    Somerville, New Jersey, 08876

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Aurora Medical Center in Summit

    Summit, Wisconsin, 53066

  • ProMedica Flower Hospital

    Sylvania, Ohio, 43560

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Corewell Health Beaumont Troy Hospital

    Troy, Michigan, 48085

  • Michigan Healthcare Professionals Troy

    Troy, Michigan, 48098

  • Saint Luke's Cancer Institute - Twin Falls

    Twin Falls, Idaho, 83301

  • Vince Lombardi Cancer Clinic-Two Rivers

    Two Rivers, Wisconsin, 54241

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

  • Reading Hospital

    West Reading, Pennsylvania, 19611

  • Dickstein Cancer Treatment Center

    White Plains, New York, 10601

  • Ascension Via Christi Hospitals Wichita

    Wichita, Kansas, 67214

Other trials in United States

Canada10 sites

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • McGill University Department of Oncology

    Montreal, Quebec, H2W 1S6

  • CHUM - Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Ottawa Hospital and Cancer Center-General Campus

    Ottawa, Ontario, K1H 8L6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Odette Cancer Centre- Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Israel1 site

  • Rabin Medical Center

    Petah Tikva, 49100

Other trials in Israel

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the ability of postcystectomy adjuvant radiotherapy to safely reduce pelvic tumor recurrence, defined as pelvic recurrence-free survival.

SECONDARY OBJECTIVES:

  1. 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.

Being tested
Intensity-Modulated Radiation Therapy
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensity-Modulated Radiation TherapyRadiation

    Also called IMRT

    Postoperative adjuvant IMRT radiotherapy 50.4 Gy in 28 fractions. In patients not getting postoperative adjuvant chemotherapy the radiation treatment must begin within 140 days after cystectomy. For patients getting adjuvant chemotherapy radiation treatment must start within 49 days of completing chemotherapy.

Study groups in NCT02316548
Study groupRoleWhat they receive
No Radiation TherapyNo interventionPatients do not receive radiation therapy (RT).
Intensity-modulated radiation therapy (IMRT)ExperimentalPostoperative adjuvant intensity-modulated radiation therapy (IMRT).
Receives: Radiation: Intensity-Modulated Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pelvic Recurrence-free Survival (PRFS)

    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.

    Measured: From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months

Secondary outcomes (2)

  1. Disease Free Survival (DFS)

    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.

    Measured: From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months

  2. Number of Patients With Bowel Toxicity

    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.

    Measured: From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2014 (estimated)
  2. Study startFeb 2015
  3. Primary completion1 Feb 2017
  4. Study completion1 Feb 2017

Why it stopped: Trial will not meet CTEP Early Phase Trial Slow Accrual Guidelines

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02316548
Sponsor's protocol ID
NRG-GU001
Other IDs
NCI-2014-02061, NRG-GU001, NRG-GU001, U10CA180868
Status last verified
Jul 2025
First submitted
10 Dec 2014
Last updated
22 May 2026
Data monitoring committee
Yes
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intensity-Modulated Radiation Therapy in people with Stage III Bladder Cancer and Stage IV Bladder Cancer, run by NRG Oncology at 127 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 127 sites in United States, Canada, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02316548.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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