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NCT02316548

PHASE2

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

Sponsor: NRG Oncology

View on ClinicalTrials.gov

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.

Official title: Randomized Phase II Trial of Postoperative Adjuvant IMRT Following Cystectomy for pT3/T4 Urothelial Bladder Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2015-02

Completion Date

2017-02-01

Last Updated

2026-05-22

Healthy Volunteers

Conditions

Stage III Bladder Cancer Stage IV Bladder Cancer

Interventions

RADIATION

Intensity-Modulated Radiation Therapy

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.

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

Locations (127)

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

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

Gainesville, Georgia, United States

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

Savannah, Georgia, United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, United States

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, United States

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, United States

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, 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 Pekin

Pekin, 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

Springfield Memorial Hospital

Springfield, 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

McFarland Clinic - Ames

Ames, Iowa, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, United States

Norton Hospital Pavilion and Medical Campus

Louisville, Kentucky, United States

UofL Health Medical Center Northeast

Louisville, Kentucky, United States

MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

UM Upper Chesapeake Medical Center

Bel Air, Maryland, United States

Central Maryland Radiation Oncology in Howard County

Columbia, Maryland, United States

UM Baltimore Washington Medical Center/Tate Cancer Center

Glen Burnie, Maryland, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, United States

Michigan Healthcare Professionals Clarkston

Clarkston, Michigan, United States

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Michigan Healthcare Professionals Farmington

Farmington Hills, Michigan, United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

Corewell Health Beaumont Troy Hospital

Troy, Michigan, United States

Michigan Healthcare Professionals Troy

Troy, Michigan, United States

Regions Hospital

Saint Paul, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Missouri Baptist Medical Center

St Louis, Missouri, United States

Billings Clinic Cancer Center

Billings, Montana, United States

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Renown Regional Medical Center

Reno, Nevada, United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 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

ProMedica Flower Hospital

Sylvania, Ohio, 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

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States

Saint Francis Cancer Center

Greenville, South Carolina, United States

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States

Prisma Health Cancer Institute - Greer

Greer, South Carolina, United States

Prisma Health Cancer Institute - Seneca

Seneca, 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

And 27 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (127)