Radiation Therapy With or Without Apalutamide in Treating Patients With Recurrent Prostate Cancer, the BALANCE Trial

NCT ID: NCT03371719

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-20

Study Completion Date

2026-03-01

Brief Summary

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This phase II trial studies how well radiation therapy with or without apalutamide works in treating patients with prostate cancer that has come back (recurrent). Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgen can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may lessen the amount of androgen made by the body. Giving radiation therapy and apalutamide may work better at treating prostate cancer compared to radiation therapy alone.

Detailed Description

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PRIMARY OBJECTIVE:

I. To determine whether, in men with post-prostatectomy prostate-specific antigen (PSA) recurrences, salvage radiation (SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical progression-free survival (bPFS) compared to SRT alone.

SECONDARY OBJECTIVES:

I. To assess whether molecular stratification by the PAM50 gene expression clustering will identify subsets of prostate cancer (luminal A or basal, luminal B) which derive the greatest benefit from anti-androgen therapy.

II. To assess overall survival. III. To assess cancer-specific mortality. IV. To assess metastasis-free survival. V. To assess distant metastasis. VI. To assess local-regional progression. VII. To assess PSA nadir during first year of treatment and prior to initiation of any hormonal salvage therapy.

VIII. To assess initiation of salvage hormonal therapy. IX. To assess PSA with a non-castrate testosterone at 1 and 3 years post randomization: PSA \< 0.1 ng/ml and testosterone \>= 50 ng/dl.

X. To assess acute and late physician-reported morbidity (per the Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) after SRT +/- apalutamide.

XI. To assess acute and late patient-reported symptomatic adverse events morbidity (per the patient reported outcomes \[PRO\]-CTCAE) after SRT +/- apalutamide.

XII. To assess testosterone levels at 3, 6, 9, 12, and 36 months post randomization.

EXPLORATORY OBJECTIVE:

I. To assess the prognostic and predictive value of the genomic classifier Decipher.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients undergo external beam radiation therapy on day 1 for 7-8 weeks. Beginning on day of radiation therapy, patients receive placebo orally (PO) once daily (QD) on days 1-30. Treatment repeats every 30 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

ARM 2: Patients undergo external beam radiation therapy on day 1 for 7-8 weeks. Beginning on day of radiation therapy, patients receive apalutamide PO QD on days 1-30. Treatment repeats every 30 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, then every 6 months for 3 years, and then yearly thereafter.

Conditions

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Recurrent Prostate Carcinoma Stage III Prostate Adenocarcinoma AJCC v7 Stage IV Prostate Adenocarcinoma AJCC v7

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1 (radiation therapy, placebo)

Patients undergo external beam radiation therapy on day 1 for 7-8 weeks. Beginning on day of radiation therapy, patients receive placebo PO QD on days 1-30. Treatment repeats every 30 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Group Type ACTIVE_COMPARATOR

External Beam Radiation Therapy

Intervention Type RADIATION

Undergo external beam radiation therapy

Placebo Administration

Intervention Type OTHER

Given PO

Arm 2 (radiation therapy, apalutamide)

Patients undergo external beam radiation therapy on day 1 for 7-8 weeks. Beginning on day of radiation therapy, patients receive apalutamide PO QD on days 1-30. Treatment repeats every 30 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

Apalutamide

Intervention Type DRUG

Given PO

External Beam Radiation Therapy

Intervention Type RADIATION

Undergo external beam radiation therapy

Interventions

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Apalutamide

Given PO

Intervention Type DRUG

External Beam Radiation Therapy

Undergo external beam radiation therapy

Intervention Type RADIATION

Placebo Administration

Given PO

Intervention Type OTHER

Other Intervention Names

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ARN 509 ARN-509 ARN509 Erleada JNJ 56021927 JNJ-56021927 Definitive Radiation Therapy EBRT External Beam Radiation External Beam Radiotherapy External Beam Radiotherapy (conventional) External Beam RT external radiation External Radiation Therapy external-beam radiation Radiation, External Beam Teleradiotherapy Teletherapy Teletherapy Radiation

Eligibility Criteria

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Inclusion Criteria

* Pathologically (histologically) proven diagnosis of prostate adenocarcinoma; prostatectomy must have been performed within 10 years prior to Step 1 registration and any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted
* Post-prostatectomy patients with a detectable serum PSA (\>= 0.1, but =\< 1.0 ng/mL) at study entry (within 90 days of Step 1 registration) and at least one of the following:

* Gleason score 7-10 (International Society of Urological Pathology \[ISUP\] grade group 2 to 5)
* ISUP grade group:

* Grade group 1 = Gleason score =\< 6,
* Grade group 2 = Gleason score 3 + 4 = 7,
* Grade group 3 = Gleason score 4 + 3 = 7,
* Grade group 4 = Gleason score 8,
* Grade group 5 = Gleason scores 9 and 10
* \>= T3a disease
* Persistent elevation of PSA after prostatectomy measured within 90 days after surgery (PSA never became undetectable) of \> 0.04 but \< 0.2 ng/mL (PSA nadir)
* pN0 or pNx
* History/physical examination within 90 days prior to Step 1 registration
* Karnofsky performance status of 70-100 within 90 days prior to Step 1 registration
* Surgical formalin-fixed paraffin-embedded (FFPE) specimen must be available for submission to GenomeDx for genomic analysis on Decipher GRID platform; Note: if Decipher results have already been obtained, in lieu of tissue, results must be submitted to GenomeDx for validation and for GenomeDx to provide the subtyping needed for stratification
* Prior androgen deprivation therapy (luteinizing hormone-releasing hormone \[LHRH\] agonist and/or non-steroidal anti-androgen) is allowed if discontinued at least 90 days prior to Step 1 registration and given for =\< 90 days duration

* For example: patients on prior LHRH analogs (post-prostatectomy), the discontinuation date should be calculated based on the expected duration of the sustained release injection, not simply the injection date of the drug; for instance, if a 22.5 mg sustained release dose of leuprolide acetate is given (3 month duration), then the expected duration of such a dose would be 90 days after the injection date; for a 7.5 mg leuprolide (1 month duration), the discontinuation date would be 30 days after the injection date
* Please note: finasteride or dutasteride must be stopped before treatment starts but prior usage will not affect eligibility
* Hemoglobin \>= 9.0 g/dL, independent of transfusion and/or growth factors within 90 days prior to Step 1 registration
* Platelet count \>= 100,000 x 10\^9/uL independent of transfusion and/or growth factors within 90 days prior to Step 1 registration
* Serum albumin \>= 3.0 g/dL within 90 days prior to Step 1 registration
* Glomerular filtration rate (GFR) \>= 35 mL/min estimated by Cockcroft-Gault or measured directly by 24 hour urine creatinine within 90 days prior to Step 1 registration
* Serum total bilirubin =\< 1.5 x upper limit of normal (ULN) (Note: in subjects with Gilbert's syndrome, if total bilirubin is \> 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =\< 1.5 x ULN, subject is eligible) within 90 days prior to Step 1 registration
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 2.5 x ULN within 90 days prior to Step 1 registration
* Testosterone \> 50 ng/dL within 90 days prior to Step 1 registration
* Concomitant medications known to lower the seizure threshold discontinued or substituted at least 4 weeks (30 days) prior to Step 1 registration
* The patient must agree to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agree to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug
* The patient must agree not to donate sperm during the study treatment and for 3 months after receiving the last dose of study drug
* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

Exclusion Criteria

* PRIOR TO STEP 1 REGISTRATION:
* Definitive clinical, radiologic, or pathologic evidence of metastatic disease (M1) or lymph node involvement (N1)
* Prior invasive malignancy (except non-melanomatous skin cancer, carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma) unless disease free for a minimum of 2 years
* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
* History of any of the following:

* Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year prior to Step 1 registration)
* History of documented inflammatory bowel disease
* Transmural myocardial infarction within the last 4 months prior to Step 1 registration
* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to Step 1 registration
* History of any condition that in the opinion of the investigator, would preclude participation in this study
* Current evidence of any of the following:

* Known gastrointestinal disorder affecting absorption of oral medications
* Active uncontrolled infection (e.g., human immunodeficiency virus \[HIV\] or viral hepatitis)
* Uncontrolled hypertension
* Any current condition that in the opinion of the investigator, would preclude participation in this study
* Prior whole gland ablative therapy (i.e. cryoablation or high intensity focused ultrasound \[HIFU\]) for prostate cancer is not allowed
* HIV positive with CD4 count \< 200 cells/microliter within 30 days prior to registration
* HIV patients under treatment with highly active antiretroviral therapy (HAART) within 30 days prior to registration regardless of CD4 count; (Note: HIV testing is not required for eligibility for this protocol as it is self-reported; this exclusion criterion is necessary because the treatments involved in this protocol may be immunosuppressive and/or interact with HAART)
* Patients must not plan to participate in any other clinical trials while receiving treatment on this study or being followed post-protocol therapy
* PRIOR TO STEP 2 REGISTRATION:
* For patients who have not undergone prior Decipher analysis, submission of the specimen to GenomeDx should be as soon as possible after study registration (Step 1) as these results can take up 21 days after the specimen is received at GenomeDx; Step 2 registration must occur within 6 weeks (42 days) of Step 1 registration; if Decipher results have already been obtained, in lieu of tissue, results must be submitted to GenomeDx for validation
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

NRG Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Felix Y Feng

Role: PRINCIPAL_INVESTIGATOR

NRG Oncology

Locations

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Arizona Center for Cancer Care - Gilbert

Gilbert, Arizona, United States

Site Status

Arizona Center for Cancer Care-Peoria

Peoria, Arizona, United States

Site Status

Arizona Center for Cancer Care - Scottsdale

Scottsdale, Arizona, United States

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Arizona Center for Cancer Care-Surprise

Surprise, Arizona, United States

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

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Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

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Marin General Hospital

Greenbrae, California, United States

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Los Angeles General Medical Center

Los Angeles, California, United States

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USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

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Cedars Sinai Medical Center

Los Angeles, California, United States

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Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, United States

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Sutter Medical Center Sacramento

Sacramento, California, United States

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University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

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Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, United States

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Sutter Solano Medical Center/Cancer Center

Vallejo, California, United States

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UCHealth University of Colorado Hospital

Aurora, Colorado, United States

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Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

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UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

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Memorial Hospital North

Colorado Springs, Colorado, United States

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Poudre Valley Hospital

Fort Collins, Colorado, United States

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Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, United States

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Valley View Hospital Cancer Center

Glenwood Springs, Colorado, United States

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UCHealth Greeley Hospital

Greeley, Colorado, United States

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Medical Center of the Rockies

Loveland, Colorado, United States

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Stamford Hospital/Bennett Cancer Center

Stamford, Connecticut, United States

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Helen F Graham Cancer Center

Newark, Delaware, United States

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Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

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Beebe Health Campus

Rehoboth Beach, Delaware, United States

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George Washington University Medical Center

Washington D.C., District of Columbia, United States

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AdventHealth Altamonte

Altamonte Springs, Florida, United States

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Regional Cancer Center-Lee Memorial Health System

Fort Myers, Florida, United States

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AdventHealth Kissimmee

Kissimmee, Florida, United States

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AdventHealth Orlando

Orlando, Florida, United States

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AdventHealth East Orlando

Orlando, Florida, United States

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Cleveland Clinic-Weston

Weston, Florida, United States

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AdventHealth Winter Park

Winter Park, Florida, United States

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Grady Health System

Atlanta, Georgia, United States

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Emory University Hospital Midtown

Atlanta, Georgia, United States

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Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

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Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

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Northside Hospital

Atlanta, Georgia, United States

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Augusta University Medical Center

Augusta, Georgia, United States

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

Savannah, Georgia, United States

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Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States

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Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, United States

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Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, United States

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Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, United States

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Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, United States

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Rush MD Anderson Cancer Center

Chicago, Illinois, United States

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University of Illinois

Chicago, Illinois, United States

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Decatur Memorial Hospital

Decatur, Illinois, United States

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Crossroads Cancer Center

Effingham, Illinois, United States

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Edward Hines Jr VA Hospital

Hines, Illinois, United States

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Loyola University Medical Center

Maywood, Illinois, United States

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Illinois CancerCare-Peoria

Peoria, Illinois, United States

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OSF Saint Francis Radiation Oncology at Peoria Cancer Center

Peoria, Illinois, United States

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OSF Saint Francis Medical Center

Peoria, Illinois, United States

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Southern Illinois University School of Medicine

Springfield, Illinois, United States

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Springfield Clinic

Springfield, Illinois, United States

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Springfield Memorial Hospital

Springfield, Illinois, United States

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Carle Cancer Center

Urbana, Illinois, United States

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Parkview Hospital Randallia

Fort Wayne, Indiana, United States

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Parkview Regional Medical Center

Fort Wayne, Indiana, United States

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Goshen Center for Cancer Care

Goshen, Indiana, United States

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Reid Health

Richmond, Indiana, United States

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Mercy Cancer Center-West Lakes

Clive, Iowa, United States

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UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, United States

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Greater Regional Medical Center

Creston, Iowa, United States

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Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

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UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, United States

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Mercy Medical Center-West Lakes

West Des Moines, Iowa, United States

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University of Kansas Cancer Center

Kansas City, Kansas, United States

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The University of Kansas Cancer Center - Olathe

Olathe, Kansas, United States

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University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, United States

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Salina Regional Health Center

Salina, Kansas, United States

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University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

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University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

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Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

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East Jefferson General Hospital

Metairie, Louisiana, United States

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LSU Healthcare Network / Metairie Multi-Specialty Clinic

Metairie, Louisiana, United States

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MaineHealth Coastal Cancer Treatment Center

Bath, Maine, United States

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MaineHealth Waldo Hospital

Belfast, Maine, United States

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MaineHealth Maine Medical Center - Biddeford

Biddeford, Maine, United States

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Lafayette Family Cancer Center-EMMC

Brewer, Maine, United States

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MaineHealth Stephens Hospital

Norway, Maine, United States

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MaineHealth Maine Medical Center - Portland

Portland, Maine, United States

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Penobscot Bay Medical Center

Rockport, Maine, United States

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MaineHealth Cancer Care and IV Therapy - Sanford

Sanford, Maine, United States

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MaineHealth Cancer Care Center of York County

Sanford, Maine, United States

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MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, United States

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MaineHealth Cancer Care and IV Therapy - South Portland

South Portland, Maine, United States

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University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

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Saint Agnes Hospital

Baltimore, Maryland, United States

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Central Maryland Radiation Oncology in Howard County

Columbia, Maryland, United States

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UM Baltimore Washington Medical Center/Tate Cancer Center

Glen Burnie, Maryland, United States

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Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

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Lowell General Hospital

Lowell, Massachusetts, United States

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Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

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University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

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Bronson Battle Creek

Battle Creek, Michigan, United States

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Trinity Health Medical Center - Brighton

Brighton, Michigan, United States

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Trinity Health Medical Center - Canton

Canton, Michigan, United States

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Chelsea Hospital

Chelsea, Michigan, United States

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Michigan Healthcare Professionals Clarkston

Clarkston, Michigan, United States

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Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, United States

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Corewell Health Dearborn Hospital

Dearborn, Michigan, United States

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Henry Ford Hospital

Detroit, Michigan, United States

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Michigan State University

East Lansing, Michigan, United States

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Michigan Healthcare Professionals Farmington

Farmington Hills, Michigan, United States

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Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

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Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, United States

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West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

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Corewell Health Lakeland Hospitals - Niles Hospital

Niles, Michigan, United States

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Corewell Health Reed City Hospital

Reed City, Michigan, United States

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Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

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Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, United States

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Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Saint Joseph, Michigan, United States

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Munson Medical Center

Traverse City, Michigan, United States

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Corewell Health Beaumont Troy Hospital

Troy, Michigan, United States

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Michigan Healthcare Professionals Troy

Troy, Michigan, United States

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Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States

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University of Michigan Health - West

Wyoming, Michigan, United States

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Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, United States

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Fairview Ridges Hospital

Burnsville, Minnesota, United States

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Mercy Hospital

Coon Rapids, Minnesota, United States

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Fairview Southdale Hospital

Edina, Minnesota, United States

Site Status

Unity Hospital

Fridley, Minnesota, United States

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Mayo Clinic Health Systems-Mankato

Mankato, Minnesota, United States

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Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, United States

Site Status

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Site Status

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

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Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

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Hennepin County Medical Center

Minneapolis, Minnesota, United States

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Minneapolis VA Medical Center

Minneapolis, Minnesota, United States

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Health Partners Inc

Minneapolis, Minnesota, United States

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Monticello Cancer Center

Monticello, Minnesota, United States

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North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud, Minnesota, United States

Site Status

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

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Regions Hospital

Saint Paul, Minnesota, United States

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United Hospital

Saint Paul, Minnesota, United States

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Saint Francis Regional Medical Center

Shakopee, Minnesota, United States

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Lakeview Hospital

Stillwater, Minnesota, United States

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Ridgeview Medical Center

Waconia, Minnesota, United States

Site Status

Rice Memorial Hospital

Willmar, Minnesota, United States

Site Status

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Site Status

Fairview Lakes Medical Center

Wyoming, Minnesota, United States

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University of Mississippi Medical Center

Jackson, Mississippi, United States

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Mercy Cancer Center - Cape Girardeau

Cape Girardeau, Missouri, United States

Site Status

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Site Status

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Site Status

MU Health Care Goldschmidt Cancer Center

Jefferson City, Missouri, United States

Site Status

Kansas City Veterans Affairs Medical Center

Kansas City, Missouri, United States

Site Status

University of Kansas Cancer Center - North

Kansas City, Missouri, United States

Site Status

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, United States

Site Status

Phelps Health Delbert Day Cancer Institute

Rolla, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Siteman Cancer Center-South County

St Louis, Missouri, United States

Site Status

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Site Status

Billings Clinic Cancer Center

Billings, Montana, United States

Site Status

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States

Site Status

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Site Status

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Site Status

Alegent Health Bergan Mercy Medical Center

Omaha, Nebraska, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada-Horizon Ridge

Henderson, Nevada, United States

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Las Vegas Cancer Center-Henderson

Henderson, Nevada, United States

Site Status

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada-Southeast Henderson

Henderson, Nevada, United States

Site Status

Oncology Las Vegas - Henderson

Henderson, Nevada, United States

Site Status

Desert West Surgery

Las Vegas, Nevada, United States

Site Status

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, United States

Site Status

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

Site Status

Hope Cancer Care of Nevada

Las Vegas, Nevada, United States

Site Status

Radiation Oncology Centers of Nevada Central

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-San Martin

Las Vegas, Nevada, United States

Site Status

Radiation Oncology Centers of Nevada Southeast

Las Vegas, Nevada, United States

Site Status

Cancer Therapy and Integrative Medicine

Las Vegas, Nevada, United States

Site Status

Ann M Wierman MD LTD

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada - Northwest

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-Tenaya

Las Vegas, Nevada, United States

Site Status

Oncology Las Vegas - Tenaya

Las Vegas, Nevada, United States

Site Status

OptumCare Cancer Care at MountainView

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada-Summerlin

Las Vegas, Nevada, United States

Site Status

Summerlin Hospital Medical Center

Las Vegas, Nevada, United States

Site Status

Las Vegas Cancer Center-Medical Center

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Site Status

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada - Central Valley

Las Vegas, Nevada, United States

Site Status

University Cancer Center

Las Vegas, Nevada, United States

Site Status

Hope Cancer Care of Nevada-Pahrump

Pahrump, Nevada, United States

Site Status

Radiation Oncology Associates

Reno, Nevada, United States

Site Status

New Hampshire Oncology Hematology PA-Concord

Concord, New Hampshire, United States

Site Status

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States

Site Status

Solinsky Center for Cancer Care

Manchester, New Hampshire, United States

Site Status

Virtua Memorial

Mount Holly, New Jersey, United States

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Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status

Sidney Kimmel Cancer Center Washington Township

Sewell, New Jersey, United States

Site Status

Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, United States

Site Status

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Site Status

New Mexico Oncology Hematology Consultants

Albuquerque, New Mexico, United States

Site Status

New York-Presbyterian/Brooklyn Methodist Hospital

Brooklyn, New York, United States

Site Status

Sands Cancer Center

Canandaigua, New York, United States

Site Status

Mary Imogene Bassett Hospital

Cooperstown, New York, United States

Site Status

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

Site Status

Wilmot Cancer Institute Radiation Oncology at Greece

Rochester, New York, United States

Site Status

Highland Hospital

Rochester, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

Stony Brook University Medical Center

Stony Brook, New York, United States

Site Status

State University of New York Upstate Medical University

Syracuse, New York, United States

Site Status

James J Peters VA Medical Center

The Bronx, New York, United States

Site Status

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Site Status

Novant Cancer Institute Radiation Oncology - Supply

Supply, North Carolina, United States

Site Status

Novant Health Cancer Institute Radiation Oncology - Wilmington

Wilmington, North Carolina, United States

Site Status

Novant Health New Hanover Regional Medical Center

Wilmington, North Carolina, United States

Site Status

Summa Health System - Akron Campus

Akron, Ohio, United States

Site Status

Cleveland Clinic Akron General

Akron, Ohio, United States

Site Status

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, United States

Site Status

Indu and Raj Soin Medical Center

Beavercreek, Ohio, United States

Site Status

Dayton Physicians LLC-Miami Valley South

Centerville, Ohio, United States

Site Status

Miami Valley Hospital South

Centerville, Ohio, United States

Site Status

Geauga Hospital

Chardon, Ohio, United States

Site Status

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States

Site Status

Oncology Hematology Care Inc-Kenwood

Cincinnati, Ohio, United States

Site Status

Case Western Reserve University

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

The Mark H Zangmeister Center

Columbus, Ohio, United States

Site Status

Good Samaritan Hospital - Dayton

Dayton, Ohio, United States

Site Status

Miami Valley Hospital

Dayton, Ohio, United States

Site Status

Dayton Physician LLC - Englewood

Dayton, Ohio, United States

Site Status

Miami Valley Hospital North

Dayton, Ohio, United States

Site Status

Armes Family Cancer Center

Findlay, Ohio, United States

Site Status

Blanchard Valley Hospital

Findlay, Ohio, United States

Site Status

Orion Cancer Care

Findlay, Ohio, United States

Site Status

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, United States

Site Status

Dayton Physicians LLC-Atrium

Franklin, Ohio, United States

Site Status

Dayton Physicians LLC-Wayne

Greenville, Ohio, United States

Site Status

Wayne Hospital

Greenville, Ohio, United States

Site Status

Greater Dayton Cancer Center

Kettering, Ohio, United States

Site Status

First Dayton Cancer Care

Kettering, Ohio, United States

Site Status

Kettering Medical Center

Kettering, Ohio, United States

Site Status

Cleveland Clinic Cancer Center Mansfield

Mansfield, Ohio, United States

Site Status

Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, United States

Site Status

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, United States

Site Status

UH Seidman Cancer Center at Southwest General Hospital

Middleburg Heights, Ohio, United States

Site Status

University Hospitals Parma Medical Center

Parma, Ohio, United States

Site Status

University Hospitals Portage Medical Center

Ravenna, Ohio, United States

Site Status

North Coast Cancer Care

Sandusky, Ohio, United States

Site Status

UH Seidman Cancer Center at Firelands Regional Medical Center

Sandusky, Ohio, United States

Site Status

Springfield Regional Cancer Center

Springfield, Ohio, United States

Site Status

Springfield Regional Medical Center

Springfield, Ohio, United States

Site Status

Cleveland Clinic Cancer Center Strongsville

Strongsville, Ohio, United States

Site Status

Dayton Physicians LLC - Troy

Troy, Ohio, United States

Site Status

Upper Valley Medical Center

Troy, Ohio, United States

Site Status

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States

Site Status

UHHS-Westlake Medical Center

Westlake, Ohio, United States

Site Status

Cleveland Clinic Wooster Family Health and Surgery Center

Wooster, Ohio, United States

Site Status

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Cancer Treatment Centers of America

Tulsa, Oklahoma, United States

Site Status

Legacy Mount Hood Medical Center

Gresham, Oregon, United States

Site Status

Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, United States

Site Status

UPMC Altoona

Altoona, Pennsylvania, United States

Site Status

UPMC-Heritage Valley Health System Beaver

Beaver, Pennsylvania, United States

Site Status

Saint Luke's University Hospital-Bethlehem Campus

Bethlehem, Pennsylvania, United States

Site Status

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, United States

Site Status

Northeast Radiation Oncology Center

Dunmore, Pennsylvania, United States

Site Status

UPMC Cancer Center at UPMC Horizon

Farrell, Pennsylvania, United States

Site Status

UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania, United States

Site Status

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, United States

Site Status

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

UPMC-Johnstown/John P. Murtha Regional Cancer Center

Johnstown, Pennsylvania, United States

Site Status

UPMC Cancer Center at UPMC McKeesport

McKeesport, Pennsylvania, United States

Site Status

UPMC Cancer Center - Monroeville

Monroeville, Pennsylvania, United States

Site Status

UPMC Hillman Cancer Center in Coraopolis

Moon Township, Pennsylvania, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Jefferson Torresdale Hospital

Philadelphia, Pennsylvania, United States

Site Status

UPMC-Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

Site Status

UPMC-Saint Margaret

Pittsburgh, Pennsylvania, United States

Site Status

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, United States

Site Status

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, United States

Site Status

UPMC-Saint Clair Hospital Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status

Guthrie Medical Group PC-Robert Packer Hospital

Sayre, Pennsylvania, United States

Site Status

UPMC Cancer Center at UPMC Northwest

Seneca, Pennsylvania, United States

Site Status

UPMC Uniontown Hospital Radiation Oncology

Uniontown, Pennsylvania, United States

Site Status

UPMC Washington Hospital Radiation Oncology

Washington, Pennsylvania, United States

Site Status

Reading Hospital

West Reading, Pennsylvania, United States

Site Status

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, United States

Site Status

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States

Site Status

Self Regional Healthcare

Greenwood, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Greer

Greer, South Carolina, United States

Site Status

The Radiation Oncology Center-Hilton Head/Bluffton

Hilton Head Island, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, United States

Site Status

Rapid City Regional Hospital

Rapid City, South Dakota, United States

Site Status

The West Clinic - Wolf River

Germantown, Tennessee, United States

Site Status

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Site Status

Audie L Murphy VA Hospital

San Antonio, Texas, United States

Site Status

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

American Fork Hospital / Huntsman Intermountain Cancer Center

American Fork, Utah, United States

Site Status

Sandra L Maxwell Cancer Center

Cedar City, Utah, United States

Site Status

Farmington Health Center

Farmington, Utah, United States

Site Status

Logan Regional Hospital

Logan, Utah, United States

Site Status

Intermountain Medical Center

Murray, Utah, United States

Site Status

McKay-Dee Hospital Center

Ogden, Utah, United States

Site Status

Utah Valley Regional Medical Center

Provo, Utah, United States

Site Status

Riverton Hospital

Riverton, Utah, United States

Site Status

Utah Cancer Specialists-Salt Lake City

Salt Lake City, Utah, United States

Site Status

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Site Status

LDS Hospital

Salt Lake City, Utah, United States

Site Status

Saint George Regional Medical Center

St. George, Utah, United States

Site Status

Southwestern Vermont Medical Center

Bennington, Vermont, United States

Site Status

Central Vermont Medical Center/National Life Cancer Treatment

Berlin Corners, Vermont, United States

Site Status

University of Vermont Medical Center

Burlington, Vermont, United States

Site Status

University of Vermont and State Agricultural College

Burlington, Vermont, United States

Site Status

Dartmouth Cancer Center - North

Saint Johnsbury, Vermont, United States

Site Status

Naval Medical Center - Portsmouth

Portsmouth, Virginia, United States

Site Status

Hunter Holmes McGuire Veterans Administration Medical Center

Richmond, Virginia, United States

Site Status

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, United States

Site Status

Legacy Salmon Creek Hospital

Vancouver, Washington, United States

Site Status

Providence Saint Mary Regional Cancer Center

Walla Walla, Washington, United States

Site Status

West Virginia University Healthcare

Morgantown, West Virginia, United States

Site Status

Camden Clark Medical Center

Parkersburg, West Virginia, United States

Site Status

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, United States

Site Status

Aurora Cancer Care-Grafton

Grafton, Wisconsin, United States

Site Status

Aurora BayCare Medical Center

Green Bay, Wisconsin, United States

Site Status

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, United States

Site Status

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Site Status

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, United States

Site Status

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Zablocki Veterans Administration Medical Center

Milwaukee, Wisconsin, United States

Site Status

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, United States

Site Status

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, United States

Site Status

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, United States

Site Status

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, United States

Site Status

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, United States

Site Status

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, United States

Site Status

Aurora Medical Center in Summit

Summit, Wisconsin, United States

Site Status

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, United States

Site Status

Aurora West Allis Medical Center

West Allis, Wisconsin, United States

Site Status

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, United States

Site Status

Marshfield Medical Center - Weston

Weston, Wisconsin, United States

Site Status

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Site Status

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

CIUSSSEMTL-Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Site Status

The Research Institute of the McGill University Health Centre (MUHC)

Montreal, Quebec, Canada

Site Status

CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)

Québec, Quebec, Canada

Site Status

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

Sherbrooke, Quebec, Canada

Site Status

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Site Status

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2017-01268

Identifier Type: REGISTRY

Identifier Source: secondary_id

NRG-GU006

Identifier Type: OTHER

Identifier Source: secondary_id

NRG-GU006

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180868

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NRG-GU006

Identifier Type: -

Identifier Source: org_study_id