Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery
Phase II-III Trial of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy With or Without Adjuvant Docetaxel
3 other identifiers
interventional
612
3 countries
313
Brief Summary
This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving antiandrogen therapy and radiation therapy with or without docetaxel after surgery may kill any remaining tumor cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2017
Longer than P75 for phase_2
313 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2016
CompletedFirst Posted
Study publicly available on registry
March 6, 2017
CompletedStudy Start
First participant enrolled
April 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2025
CompletedJanuary 14, 2026
January 1, 2026
8.6 years
December 30, 2016
January 13, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Freedom from progression (FFP) (Phase II)
Will be determined with a one-sided stratified log-rank test when 89 FFP events have been observed. Both unadjusted and adjusted hazard ratios and the respective 95% confidence interval will be computed. Events for FFP will be the first occurrence of biochemical failure by prostate specific antigen (PSA) \>= 0.4 ng/ml over the nadir PSA confirmed by a second PSA higher than the first by any amount, recurrence (local, regional or distant), institution of secondary androgen deprivation therapy and death from any cause.
From time of randomization to first event, assessed up to 43 months
Metastasis free survival (MFS) (Phase III)
Will be measured with a one-sided stratified log-rank test when 282 MFS events have been observed. Both unadjusted and adjusted hazard ratios and the respective 95% confidence interval will be computed.
From time of randomization to first occurrence of distant metastasis or death from any cause, assessed up to 9.5 years
Secondary Outcomes (6)
Overall survival
Time to death from any cause assessed up to 2.5 years
Time to local progression
Baseline to local or regional recurrence ignoring biochemical failure and distant recurrence and censoring for death, assessed up to 2.5 years
Proportion of undetectable prostate specific antigen (PSA) with a non-castrate testosterone
At 2.5 years
Incidence of acute adverse events scored according to the Cancer Therapy Evaluation Program active version of the Common Terminology Criteria for Adverse Events
Up to 30 days post radiation therapy
Genomic profiling in making adjuvant therapy decisions
Up to 9 years
- +1 more secondary outcomes
Other Outcomes (1)
DECIPHER signature in predicting response
Up to 9 years
Study Arms (2)
Arm I (androgen deprivation therapy, EBRT)
ACTIVE COMPARATORPatients receive androgen deprivation therapy comprising leuprolide acetate, goserelin acetate, degarelix, bicalutamide, flutamide, or nilutamide for 6 months. Beginning 8 weeks after the start of androgen deprivation therapy, patients receive EBRT for 7.5 weeks.
Arm II (androgen deprivation therapy, EBRT, docetaxel)
EXPERIMENTALPatients receive androgen deprivation therapy and EBRT as in Arm I. Within 4-6 weeks after completion of radiation therapy, patients receive docetaxel IV over 1 hour on day 1 of every 21 days for 6 cycless in the absence of disease progression or unexpected toxicity.
Interventions
Given IM
Given IV
Given PO
Given IM
Given IM
Correlative studies
Given intramuscularly (IM)
Given IM
Drug
Given orally (PO)
Undergo external beam radiation therapy
Eligibility Criteria
You may qualify if:
- Patients post-prostatectomy with baseline Gleason \>= 7 (per prostatectomy pathology)
- Baseline PSA prior to start of androgen deprivation therapy nadir \>= 0.2 ng/ml (post-operative value is never undetectable) obtained prior to step 1 registration
- Baseline testosterone level obtained post-prostatectomy prior to start of androgen deprivation therapy and prior to step 1 registration
- Pathologically (histologically) proven diagnosis of adenocarcinoma of the prostate as confirmed at time of prostatectomy; prostatectomy must have been performed within 365 days (1 year) prior to step 1 registrationand any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted; (please note: Prior ablative treatment for benign prostatic hypertrophy or focal high-intensity focused ultrasound therapy \[HIFU\] prior to prostatectomy is allowed)
- Surgical formalin-fixed paraffin-embedded (FFPE) specimen must be available for submission to GenomeDx for genomic analysis on DECIPHER GRID platform
- Please note: If a patient already has a Decipher risk score and meets all of the other eligibility criteria, the patient is eligible to be registered; however, the Decipher risk report will need to be submitted to GenomeDx for validation
- Prior androgen deprivation (luteinizing hormone-releasing hormone \[LHRH\] agonist and/or non-steroidal anti-androgen) is allowed if:
- Androgen deprivation therapy was initiated within 30 days prior to study enrollment
- Androgen deprivation therapy was given for ≤ 90 days duration prior to radical prostatectomy
- Please note: Finasteride or dutasteride must be stopped before treatment but should not determine eligibility
- Pathologically lymph node negative by pelvic lymphadenectomy (pN0) or lymph node status pathologically unknown (undissected pelvic lymph nodes \[pNx\])
- Any pT-stage based on American Joint Committee on Cancer 7th edition eligible; study entry will be based on the following diagnostic workup:
- History/physical examination within 60 days prior to step 1 registration
- Negative distant metastatic workup:
- A computed tomography (CT) scan of the abdomen and pelvis (with contrast \[CT without contrast is permitted if the patient is not a candidate for contrast, i.e., renal function or allergy\]) or magnetic resonance imaging (MRI) of the pelvis within 120 days prior to step 1 registration; (Please note: Lymph nodes will be considered negative (NO)if they are =\< 1.5 cm short axis);
- +8 more criteria
You may not qualify if:
- Definitive clinical or radiologic evidence of metastatic disease
- Prior invasive malignancy (except non-melanomatous skin cancer or other in-situ malignancies, or stage Ta bladder cancer) unless disease free for a minimum of 2 years
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if completed more than two years prior to step 1 registration; prior androgen deprivation is allowed
- Prior whole gland ablative therapy (i.e. cryoablation or high intensity focused ultrasound \[HIFU\]) for prostate cancer is not allowed
- Prostatectomy performed greater than 365 days (1 year) prior to step 1 registration
- Severe and/or active co-morbidity defined as follows:
- History of inflammatory bowel disease
- History of active hepatitis B or C; blood tests are not required to determine if the patient has had hepatitis B or C, unless the patient reports a history of hepatitis
- 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 step 1 registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within 15 days of step 1 registration or precluding study therapy at the time of step 1 registration
- Uncontrolled severe illness or medical condition (including uncontrolled diabetes), which in the judgment of the treating physician would make the administration of chemotherapy inadvisable
- Human immunodeficiency virus (HIV) positive with cluster of differentiation 4 (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 step 1 registration; note also that HIV testing is not required for eligibility for this protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)collaborator
- NRG Oncologylead
Study Sites (313)
Mobile Infirmary Medical Center
Mobile, Alabama, 36607, United States
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701, United States
Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004, United States
University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona, 85704, United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719, United States
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401, United States
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531, United States
Adventist Health Cancer Care Center Chico
Chico, California, 95973, United States
Kaiser Permanente Dublin
Dublin, California, 94568, United States
Kaiser Permanente-Fremont
Fremont, California, 94538, United States
Fresno Cancer Center
Fresno, California, 93720, United States
Kaiser Permanente-Fresno
Fresno, California, 93720, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Kaiser Permanente-Modesto
Modesto, California, 95356, United States
Kaiser Permanente Oakland-Broadway
Oakland, California, 94611, United States
Kaiser Permanente-Oakland
Oakland, California, 94611, United States
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, 95670, United States
Kaiser Permanente-Redwood City
Redwood City, California, 94063, United States
Kaiser Permanente-Richmond
Richmond, California, 94801, United States
Rohnert Park Cancer Center
Rohnert Park, California, 94928, United States
Kaiser Permanente-Roseville
Roseville, California, 95661, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661, United States
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, 95678, United States
Sutter Medical Center Sacramento
Sacramento, California, 95816, United States
Kaiser Permanente-South Sacramento
Sacramento, California, 95823, United States
South Sacramento Cancer Center
Sacramento, California, 95823, United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, 95825, United States
Naval Medical Center -San Diego
San Diego, California, 92134, United States
Kaiser Permanente-San Francisco
San Francisco, California, 94115, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, 95119, United States
Kaiser Permanente San Leandro
San Leandro, California, 94577, United States
Kaiser Permanente-San Rafael
San Rafael, California, 94903, United States
Kaiser San Rafael-Gallinas
San Rafael, California, 94903, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403, United States
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, 94080, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080, United States
Kaiser Permanente-Stockton
Stockton, California, 95210, United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, 94086, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, 96161, United States
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, 95688, United States
Kaiser Permanente-Vallejo
Vallejo, California, 94589, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, 94589, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Beebe South Coastal Health Campus
Millville, Delaware, 19967, United States
Helen F Graham Cancer Center
Newark, Delaware, 19713, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
Beebe Health Campus
Rehoboth Beach, Delaware, 19971, United States
GenesisCare USA - Aventura FP
Aventura, Florida, 33180, United States
GenesisCare USA - Aventura
Aventura, Florida, 33180, United States
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180, United States
AdventHealth Celebration
Celebration, Florida, 34747, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442, United States
GenesisCare USA - Key West
Key West, Florida, 33040, United States
AdventHealth Kissimmee
Kissimmee, Florida, 34744, United States
Lakeland Regional Health Hollis Cancer Center
Lakeland, Florida, 33805, United States
GenesisCare USA - Lakewood Ranch
Lakewood Rch, Florida, 34202, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
GenesisCare USA - Plantation
Plantation, Florida, 33324, United States
Grady Health System
Atlanta, Georgia, 30303, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
Piedmont Fayette Hospital
Fayetteville, Georgia, 30214, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Alton Memorial Hospital
Alton, Illinois, 62002, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush MD Anderson Cancer Center
Chicago, Illinois, 60612, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Edward Hospital/Cancer Center
Naperville, Illinois, 60540, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Edward Hospital/Cancer Center?Plainfield
Plainfield, Illinois, 60585, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
Parkview Hospital Randallia
Fort Wayne, Indiana, 46805, United States
Parkview Regional Medical Center
Fort Wayne, Indiana, 46845, United States
Goshen Center for Cancer Care
Goshen, Indiana, 46526, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Reid Health
Richmond, Indiana, 47374, United States
McFarland Clinic - Ames
Ames, Iowa, 50010, United States
Mercy Hospital
Cedar Rapids, Iowa, 52403, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
The University of Kansas Cancer Center - Olathe
Olathe, Kansas, 66061, United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210, United States
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka, Kansas, 66606, United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214, United States
East Jefferson General Hospital
Metairie, Louisiana, 70006, United States
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana, 70006, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland, 21044, United States
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061, United States
TidalHealth Richard A Henson Cancer Institute
Ocean Pines, Maryland, 21811, United States
TidalHealth Peninsula Regional
Salisbury, Maryland, 21801, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
Lahey Medical Center-Peabody
Peabody, Massachusetts, 01960, United States
Beth Israel Deaconess Medical Center/Winchester Center for Cancer Care
Winchester, Massachusetts, 01890, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183, United States
McLaren Cancer Institute-Clarkston
Clarkston, Michigan, 48346, United States
Michigan Healthcare Professionals Clarkston
Clarkston, Michigan, 48346, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038, United States
Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236, United States
Michigan Healthcare Professionals Farmington
Farmington Hills, Michigan, 48334, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
McLaren Cancer Institute-Flint
Flint, Michigan, 48532, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503, United States
Allegiance Health
Jackson, Michigan, 49201, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, 48910, United States
Mid-Michigan Physicians-Lansing
Lansing, Michigan, 48912, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912, United States
McLaren Cancer Institute-Lapeer Region
Lapeer, Michigan, 48446, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154, United States
Michigan Healthcare Professionals Macomb
Macomb, Michigan, 48044, United States
Michigan Healthcare Professionals Madison Heights
Madison Heights, Michigan, 48071, United States
McLaren Cancer Institute-Macomb
Mount Clemens, Michigan, 48043, United States
McLaren Cancer Institute-Central Michigan
Mount Pleasant, Michigan, 48858, United States
McLaren Cancer Institute-Northern Michigan
Petoskey, Michigan, 49770, United States
Michigan Healthcare Professionals Pontiac
Pontiac, Michigan, 48341, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341, United States
McLaren-Port Huron
Port Huron, Michigan, 48060, United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073, United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan, 48601, United States
Corewell Health Beaumont Troy Hospital
Troy, Michigan, 48085, United States
Michigan Healthcare Professionals Troy
Troy, Michigan, 48098, United States
Henry Ford Health Warren Hospital
Warren, Michigan, 48093, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322, United States
University of Michigan Health - West
Wyoming, Michigan, 49519, United States
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Saint Luke's Hospital of Duluth
Duluth, Minnesota, 55805, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, 56001, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376, United States
The University of Kansas Cancer Center-South
Kansas City, Missouri, 64131, United States
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154, United States
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064, United States
Phelps Health Delbert Day Cancer Institute
Rolla, Missouri, 65401, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Logan Health Medical Center
Kalispell, Montana, 59901, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, 89106, United States
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, 89119, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756, United States
AtlantiCare Health Park-Cape May Court House
Cape May Court House, New Jersey, 08210, United States
AtlantiCare Surgery Center
Egg Harbor, New Jersey, 08234, United States
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, 08876, United States
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, 11215, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Highland Hospital
Rochester, New York, 14620, United States
University of Rochester
Rochester, New York, 14642, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Dickstein Cancer Treatment Center
White Plains, New York, 10601, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cone Health Cancer Center
Greensboro, North Carolina, 27403, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122, United States
Geauga Hospital
Chardon, Ohio, 44024, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Mercy Cancer Center-Elyria
Elyria, Ohio, 44035, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, 44060, United States
UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights, Ohio, 44130, United States
University Hospitals Parma Medical Center
Parma, Ohio, 44129, United States
University Hospitals Portage Medical Center
Ravenna, Ohio, 44266, United States
UH Seidman Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio, 44870, United States
Springfield Regional Cancer Center
Springfield, Ohio, 45504, United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560, United States
University of Toledo
Toledo, Ohio, 43614, United States
UHHS-Westlake Medical Center
Westlake, Ohio, 44145, United States
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, 73505, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Jefferson Abington Hospital
Abington, Pennsylvania, 19001, United States
Crozer-Keystone Regional Cancer Center at Broomall
Broomall, Pennsylvania, 19008, United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, 18512, United States
Saint Vincent Hospital
Erie, Pennsylvania, 16544, United States
Crozer Regional Cancer Center at Brinton Lake
Glen Mills, Pennsylvania, 19342, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109, United States
Jefferson Hospital
Jefferson Hills, Pennsylvania, 15025, United States
Saint Mary Medical and Regional Cancer Center
Langhorne, Pennsylvania, 19047, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837, United States
Lewistown Hospital
Lewistown, Pennsylvania, 17044, United States
Forbes Hospital
Monroeville, Pennsylvania, 15146, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania, 19114, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Penn State Health Saint Joseph Medical Center
Reading, Pennsylvania, 19605, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania, 15090, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Saint Francis Cancer Center
Greenville, South Carolina, 29607, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Self Regional Healthcare
Greenwood, South Carolina, 29646, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651, United States
The Radiation Oncology Center-Hilton Head/Bluffton
Hilton Head Island, South Carolina, 29926, United States
Carolina Regional Cancer Center
Myrtle Beach, South Carolina, 29577, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565, United States
UTMB Cancer Center at Victory Lakes
League City, Texas, 77573, United States
Sandra L Maxwell Cancer Center
Cedar City, Utah, 84720, United States
Logan Regional Hospital
Logan, Utah, 84321, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, 84106, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Saint George Regional Medical Center
St. George, Utah, 84770, United States
Southwestern Vermont Medical Center
Bennington, Vermont, 05201, United States
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, 05819, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
MultiCare Auburn Medical Center
Auburn, Washington, 98001, United States
West Virginia University Charleston Division
Charleston, West Virginia, 25304, United States
West Virginia University Healthcare
Morgantown, West Virginia, 26506, United States
Camden Clark Medical Center
Parkersburg, West Virginia, 26101, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
University of Wisconsin Carbone Cancer Center - Johnson Creek
Johnson Creek, Wisconsin, 53038, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142, United States
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051, United States
Ascension Columbia Saint Mary's Hospital Ozaukee
Mequon, Wisconsin, 53097, United States
Ascension Columbia Saint Mary's Hospital - Milwaukee
Milwaukee, Wisconsin, 53211, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233, United States
Zablocki Veterans Administration Medical Center
Milwaukee, Wisconsin, 53295, United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548, United States
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482, United States
Aurora Medical Center in Summit
Summit, Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476, United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494, United States
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
Centro Comprensivo de Cancer de UPR
San Juan, 00927, Puerto Rico
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark D Hurwitz
NRG Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2016
First Posted
March 6, 2017
Study Start
April 5, 2017
Primary Completion
October 31, 2025
Study Completion
October 31, 2025
Last Updated
January 14, 2026
Record last verified: 2026-01