Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery

NCT ID: NCT03070886

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/PHASE3

Total Enrollment

612 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-05

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVE:

I. To assess the benefit of docetaxel as measured by improvement in freedom from progression (phase II) and subsequently metastasis free survival (phase III) when given in combination with radiation and androgen deprivation in treatment of high risk prostate cancer post-radical prostatectomy.

SECONDARY OBJECTIVES:

I. To assess overall survival. II. To assess local time to progression. III. To assess undetectable prostate-specific antigen (PSA) with a non-castrate testosterone at 2.5 years post treatment.

IV. To assess the utility of genomic profiling in making adjuvant therapy decisions post-prostatectomy.

V. To assess toxicity of docetaxel in the post-operative setting when combined with radiation and androgen deprivation therapy.

VI. To assess treatment response by genomically defined sub-groups of prostate cancer patients.

EXPLORATORY OBJECTIVE:

I. To optimize quality assurance methodologies and processes for radiotherapy and imaging, with machine learning strategies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients 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 external beam radiation therapy (EBRT) for 7.5 weeks.

ARM II: Patients receive androgen deprivation therapy and EBRT as in Arm I. Within 4-6 weeks after completion of radiation therapy, patients receive docetaxel intravenously (IV) over 1 hour on day 1 of every 21 days for 6 cycles in the absence of disease progression or unexpected 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.

Conditions

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Stage I Prostate Adenocarcinoma AJCC v7 Stage II Prostate Adenocarcinoma AJCC v7 Stage III Prostate Adenocarcinoma AJCC v7

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I (androgen deprivation therapy, EBRT)

Patients 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.

Group Type ACTIVE_COMPARATOR

Bicalutamide

Intervention Type DRUG

Given orally (PO)

Degarelix

Intervention Type DRUG

Given IM

External Beam Radiation Therapy

Intervention Type RADIATION

Undergo external beam radiation therapy

Flutamide

Intervention Type DRUG

Given PO

Goserelin

Intervention Type DRUG

Given IM

Goserelin Acetate

Intervention Type DRUG

Given IM

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Leuprolide

Intervention Type DRUG

Given intramuscularly (IM)

Leuprolide Acetate

Intervention Type DRUG

Given IM

Nilutamide

Intervention Type DRUG

Drug

Arm II (androgen deprivation therapy, EBRT, docetaxel)

Patients 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.

Group Type EXPERIMENTAL

Bicalutamide

Intervention Type DRUG

Given orally (PO)

Degarelix

Intervention Type DRUG

Given IM

Docetaxel

Intervention Type DRUG

Given IV

External Beam Radiation Therapy

Intervention Type RADIATION

Undergo external beam radiation therapy

Flutamide

Intervention Type DRUG

Given PO

Goserelin

Intervention Type DRUG

Given IM

Goserelin Acetate

Intervention Type DRUG

Given IM

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Leuprolide

Intervention Type DRUG

Given intramuscularly (IM)

Leuprolide Acetate

Intervention Type DRUG

Given IM

Nilutamide

Intervention Type DRUG

Drug

Interventions

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Bicalutamide

Given orally (PO)

Intervention Type DRUG

Degarelix

Given IM

Intervention Type DRUG

Docetaxel

Given IV

Intervention Type DRUG

External Beam Radiation Therapy

Undergo external beam radiation therapy

Intervention Type RADIATION

Flutamide

Given PO

Intervention Type DRUG

Goserelin

Given IM

Intervention Type DRUG

Goserelin Acetate

Given IM

Intervention Type DRUG

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Leuprolide

Given intramuscularly (IM)

Intervention Type DRUG

Leuprolide Acetate

Given IM

Intervention Type DRUG

Nilutamide

Drug

Intervention Type DRUG

Other Intervention Names

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Casodex Cassotide Cosudex ICI 176,334 ICI 176334 Utamide ASP 3550 ASP-3550 ASP3550 FE 200486 FE-200486 FE200486 Firmagon Docecad RP 56976 RP-56976 RP56976 Taxotere Taxotere Injection Concentrate 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 4'-Nitro-3'-trifluoromethylisobutyranilide Apimid Cebatrol Chimax Cytomid Drogenil Euflex Eulexine Flucinom Flucinome Flugerel Fluken Flulem FLUT Fluta-Gry Flutabene Flutacan Flutamex Flutamin Flutan Flutaplex Fugerel Grisetin Niftolide Oncosal Profamid Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)- Prostacur Prostadirex Prostica Prostogenat Sch 13521 Tafenil Tecnoflut Testotard ICI-118630 ZDX Zoladex Leuprorelin A 43818 A-43818 A43818 Abbott 43818 Abbott-43818 Carcinil Depo-Eligard Eligard Enanton Enantone Enantone-Gyn Fensolvi Ginecrin LEUP Leuplin Leuprorelin Acetate Lucrin Lucrin Depot Luprodex Depot Lupron Lupron Depot Lupron Depot-3 Month Lupron Depot-4 Month Lupron Depot-Ped Lutrate Procren Procrin Prostap TAP 144 TAP-144 TAP144 Trenantone Uno-Enantone Viadur Anandron Nilandron RU-23908

Eligibility Criteria

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Inclusion Criteria

* 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);
* Bone scan within 120 days prior to step 1 registration; (please note: a sodium fluoride \[NaF\] positron emission tomography \[PET\]/CT is an acceptable substitute and if the bone scan is suspicious, a plain x-ray, CT scan, NaF PET/CT and/or MRI must be obtained to rule out metastasis; Axumin scans are not allowed for determination of eligibility \[e.g. a positive Axumin can in the setting of negative bonescan and CT does not exclude a patient from being eligible for enrollment\]).
* Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1 within 60 days prior to step 1 registration
* Platelets \>= 100,000 cell/mm\^3 (within 60 days prior to step 1 registration based upon a complete blood count \[CBC\])
* Hemoglobin \>= 10.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 10.0 g/dl is NOT allowed) (within 60 days prior to step 1 registration based upon a CBC)
* Absolute neutrophil count \>= 1500 cells/mm\^3 (within 60 days prior to step 1 registration based upon a CBC)
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 1.5 x the upper limit of normal (within 60 days prior to step 1 registration)
* Total bilirubin (=\< 1.5 mg/dl) normal unless history of Gilbert's syndrome (within 60 days prior to step 1 registration)
* The patient or a legally authorized representative must provide study-specific informed consent prior to step 1 registration

Exclusion Criteria

* 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
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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Mark D Hurwitz

Role: PRINCIPAL_INVESTIGATOR

NRG Oncology

Locations

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Mobile Infirmary Medical Center

Mobile, Alabama, United States

Site Status

Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Site Status

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

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University of Arizona Cancer Center-Orange Grove Campus

Tucson, Arizona, United States

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Banner University Medical Center - Tucson

Tucson, Arizona, United States

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University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

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NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, United States

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Kaiser Permanente-Deer Valley Medical Center

Antioch, California, United States

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Adventist Health Cancer Care Center Chico

Chico, California, United States

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Kaiser Permanente Dublin

Dublin, California, United States

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Kaiser Permanente-Fremont

Fremont, California, United States

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Fresno Cancer Center

Fresno, California, United States

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Kaiser Permanente-Fresno

Fresno, California, United States

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UC San Diego Moores Cancer Center

La Jolla, California, United States

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Kaiser Permanente-Modesto

Modesto, California, United States

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Kaiser Permanente Oakland-Broadway

Oakland, California, United States

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Kaiser Permanente-Oakland

Oakland, California, United States

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Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, United States

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Kaiser Permanente-Redwood City

Redwood City, California, United States

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Kaiser Permanente-Richmond

Richmond, California, United States

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Rohnert Park Cancer Center

Rohnert Park, California, United States

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Kaiser Permanente-Roseville

Roseville, California, United States

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Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, United States

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The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, United States

Site Status

Sutter Medical Center Sacramento

Sacramento, California, United States

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Kaiser Permanente-South Sacramento

Sacramento, California, United States

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South Sacramento Cancer Center

Sacramento, California, United States

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Kaiser Permanente Sacramento Medical Center

Sacramento, California, United States

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Naval Medical Center -San Diego

San Diego, California, United States

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Kaiser Permanente-San Francisco

San Francisco, California, United States

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Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

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Kaiser Permanente San Leandro

San Leandro, California, United States

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Kaiser Permanente-San Rafael

San Rafael, California, United States

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Kaiser San Rafael-Gallinas

San Rafael, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Site Status

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

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Kaiser Permanente Cancer Treatment Center

South San Francisco, California, United States

Site Status

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Site Status

Kaiser Permanente-Stockton

Stockton, California, United States

Site Status

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, United States

Site Status

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, United States

Site Status

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, United States

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Kaiser Permanente-Vallejo

Vallejo, California, United States

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Sutter Solano Medical Center/Cancer Center

Vallejo, California, United States

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Kaiser Permanente-Walnut Creek

Walnut Creek, 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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Poudre Valley Hospital

Fort Collins, Colorado, United States

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Beebe South Coastal Health Campus

Millville, Delaware, 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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GenesisCare USA - Aventura FP

Aventura, Florida, United States

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GenesisCare USA - Aventura

Aventura, Florida, United States

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Mount Sinai Comprehensive Cancer Center at Aventura

Aventura, Florida, United States

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AdventHealth Celebration

Celebration, Florida, United States

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UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

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UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

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GenesisCare USA - Key West

Key West, Florida, United States

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AdventHealth Kissimmee

Kissimmee, Florida, United States

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Lakeland Regional Health Hollis Cancer Center

Lakeland, Florida, United States

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GenesisCare USA - Lakewood Ranch

Lakewood Rch, Florida, United States

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University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

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Mount Sinai Medical Center

Miami Beach, Florida, United States

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AdventHealth Orlando

Orlando, Florida, United States

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GenesisCare USA - Plantation

Plantation, 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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Piedmont Hospital

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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Piedmont Fayette Hospital

Fayetteville, Georgia, United States

Site Status

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

Savannah, Georgia, United States

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Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

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Alton Memorial Hospital

Alton, Illinois, United States

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Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Site Status

Illinois CancerCare-Canton

Canton, Illinois, United States

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Illinois CancerCare-Carthage

Carthage, Illinois, United States

Site Status

Northwestern University

Chicago, Illinois, United States

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Rush MD Anderson Cancer Center

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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Elmhurst Memorial Hospital

Elmhurst, Illinois, United States

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Illinois CancerCare-Eureka

Eureka, Illinois, United States

Site Status

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

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Ingalls Memorial Hospital

Harvey, Illinois, United States

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Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Site Status

Illinois CancerCare-Macomb

Macomb, Illinois, United States

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Loyola University Medical Center

Maywood, Illinois, United States

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Edward Hospital/Cancer Center

Naperville, Illinois, United States

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Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status

Illinois CancerCare-Pekin

Pekin, 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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Methodist Medical Center of Illinois

Peoria, Illinois, United States

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OSF Saint Francis Medical Center

Peoria, Illinois, United States

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Illinois CancerCare-Peru

Peru, Illinois, United States

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Edward Hospital/Cancer Center?Plainfield

Plainfield, Illinois, United States

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Illinois CancerCare-Princeton

Princeton, 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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Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

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Reid Health

Richmond, Indiana, United States

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McFarland Clinic - Ames

Ames, Iowa, United States

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Mercy Hospital

Cedar Rapids, 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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Cotton O'Neil Cancer Center / Stormont Vail Health

Topeka, Kansas, United States

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Ascension Via Christi Hospitals Wichita

Wichita, Kansas, 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

Site Status

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

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University of Maryland/Greenebaum Cancer Center

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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TidalHealth Richard A Henson Cancer Institute

Ocean Pines, Maryland, United States

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TidalHealth Peninsula Regional

Salisbury, Maryland, United States

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Boston Medical Center

Boston, Massachusetts, United States

Site Status

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Site Status

Lahey Medical Center-Peabody

Peabody, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center/Winchester Center for Cancer Care

Winchester, Massachusetts, United States

Site Status

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

Site Status

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, United States

Site Status

McLaren Cancer Institute-Clarkston

Clarkston, Michigan, United States

Site Status

Michigan Healthcare Professionals Clarkston

Clarkston, Michigan, United States

Site Status

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, United States

Site Status

Corewell Health Dearborn Hospital

Dearborn, Michigan, United States

Site Status

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Henry Ford Health Saint John Hospital

Detroit, Michigan, United States

Site Status

Michigan Healthcare Professionals Farmington

Farmington Hills, Michigan, United States

Site Status

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

Site Status

McLaren Cancer Institute-Flint

Flint, Michigan, United States

Site Status

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

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Allegiance Health

Jackson, Michigan, United States

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West Michigan Cancer Center

Kalamazoo, Michigan, United States

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Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, United States

Site Status

Mid-Michigan Physicians-Lansing

Lansing, Michigan, United States

Site Status

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

Site Status

McLaren Cancer Institute-Lapeer Region

Lapeer, Michigan, United States

Site Status

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Site Status

Michigan Healthcare Professionals Macomb

Macomb, Michigan, United States

Site Status

Michigan Healthcare Professionals Madison Heights

Madison Heights, Michigan, United States

Site Status

McLaren Cancer Institute-Macomb

Mount Clemens, Michigan, United States

Site Status

McLaren Cancer Institute-Central Michigan

Mount Pleasant, Michigan, United States

Site Status

McLaren Cancer Institute-Northern Michigan

Petoskey, Michigan, United States

Site Status

Michigan Healthcare Professionals Pontiac

Pontiac, Michigan, United States

Site Status

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

Site Status

McLaren-Port Huron

Port Huron, Michigan, United States

Site Status

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

Site Status

MyMichigan Medical Center Saginaw

Saginaw, Michigan, United States

Site Status

Corewell Health Beaumont Troy Hospital

Troy, Michigan, United States

Site Status

Michigan Healthcare Professionals Troy

Troy, Michigan, United States

Site Status

Henry Ford Health Warren Hospital

Warren, Michigan, United States

Site Status

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States

Site Status

University of Michigan Health - West

Wyoming, Michigan, United States

Site Status

Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, United States

Site Status

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States

Site Status

Saint Luke's Hospital of Duluth

Duluth, Minnesota, United States

Site Status

Fairview Southdale Hospital

Edina, Minnesota, United States

Site Status

Mayo Clinic Health Systems-Mankato

Mankato, Minnesota, United States

Site Status

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

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

Site Status

Regions Hospital

Saint Paul, Minnesota, United States

Site Status

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Site Status

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Site Status

The University of Kansas Cancer Center-South

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

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

Site Status

Mercy Hospital Springfield

Springfield, 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

Siteman Cancer Center at Christian Hospital

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

Logan Health Medical Center

Kalispell, Montana, United States

Site Status

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Site Status

Radiation Oncology Centers of Nevada Central

Las Vegas, Nevada, United States

Site Status

Radiation Oncology Centers of Nevada Southeast

Las Vegas, Nevada, United States

Site Status

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States

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AtlantiCare Health Park-Cape May Court House

Cape May Court House, New Jersey, United States

Site Status

AtlantiCare Surgery Center

Egg Harbor, New Jersey, United States

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Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, United States

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New York-Presbyterian/Brooklyn Methodist Hospital

Brooklyn, New York, United States

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Roswell Park Cancer Institute

Buffalo, New York, United States

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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

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Dickstein Cancer Treatment Center

White Plains, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

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Cone Health Cancer Center

Greensboro, North Carolina, United States

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Margaret R Pardee Memorial Hospital

Hendersonville, North Carolina, United States

Site Status

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States

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Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

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UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, United States

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Geauga Hospital

Chardon, Ohio, United States

Site Status

Case Western Reserve University

Cleveland, Ohio, United States

Site Status

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Miami Valley Hospital North

Dayton, Ohio, United States

Site Status

Mercy Cancer Center-Elyria

Elyria, Ohio, United States

Site Status

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, United States

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UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, United States

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UH Seidman Cancer Center at Southwest General Hospital

Middleburg Heights, Ohio, United States

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University Hospitals Parma Medical Center

Parma, Ohio, United States

Site Status

University Hospitals Portage Medical Center

Ravenna, 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

ProMedica Flower Hospital

Sylvania, Ohio, United States

Site Status

University of Toledo

Toledo, Ohio, United States

Site Status

UHHS-Westlake Medical Center

Westlake, Ohio, United States

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Cancer Centers of Southwest Oklahoma Research

Lawton, Oklahoma, United States

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University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

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Clackamas Radiation Oncology Center

Clackamas, Oregon, United States

Site Status

Providence Portland Medical Center

Portland, Oregon, United States

Site Status

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Site Status

Jefferson Abington Hospital

Abington, Pennsylvania, United States

Site Status

Crozer-Keystone Regional Cancer Center at Broomall

Broomall, Pennsylvania, United States

Site Status

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Northeast Radiation Oncology Center

Dunmore, Pennsylvania, United States

Site Status

Saint Vincent Hospital

Erie, Pennsylvania, United States

Site Status

Crozer Regional Cancer Center at Brinton Lake

Glen Mills, Pennsylvania, United States

Site Status

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, United States

Site Status

Jefferson Hospital

Jefferson Hills, Pennsylvania, United States

Site Status

Saint Mary Medical and Regional Cancer Center

Langhorne, Pennsylvania, United States

Site Status

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, United States

Site Status

Lewistown Hospital

Lewistown, Pennsylvania, United States

Site Status

Forbes Hospital

Monroeville, 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

Temple University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Penn State Health Saint Joseph Medical Center

Reading, Pennsylvania, United States

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Reading Hospital

West Reading, Pennsylvania, United States

Site Status

Wexford Health and Wellness Pavilion

Wexford, Pennsylvania, United States

Site Status

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, 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

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States

Site Status

Saint Francis Cancer Center

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

Gibbs Cancer Center-Pelham

Greer, South Carolina, United States

Site Status

The Radiation Oncology Center-Hilton Head/Bluffton

Hilton Head Island, South Carolina, United States

Site Status

Carolina Regional Cancer Center

Myrtle Beach, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, United States

Site Status

Spartanburg Medical Center

Spartanburg, South Carolina, United States

Site Status

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Site Status

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

Site Status

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Site Status

University of Texas Medical Branch

Galveston, Texas, United States

Site Status

UTMB Cancer Center at Victory Lakes

League City, Texas, United States

Site Status

Sandra L Maxwell Cancer Center

Cedar City, 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 Cancer Specialists-Salt Lake City

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

Dartmouth Cancer Center - North

Saint Johnsbury, Vermont, United States

Site Status

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Site Status

MultiCare Auburn Medical Center

Auburn, Washington, United States

Site Status

West Virginia University Charleston Division

Charleston, West Virginia, 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

Langlade Hospital and Cancer Center

Antigo, Wisconsin, United States

Site Status

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 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

University of Wisconsin Carbone Cancer Center - Johnson Creek

Johnson Creek, Wisconsin, United States

Site Status

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, United States

Site Status

Aurora Bay Area Medical Group-Marinette

Marinette, 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

Ascension Columbia Saint Mary's Hospital Ozaukee

Mequon, Wisconsin, United States

Site Status

Ascension Columbia Saint Mary's Hospital - Milwaukee

Milwaukee, 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

Aurora Sinai Medical Center

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

Drexel Town Square Health Center

Oak Creek, 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

Aspirus Regional Cancer Center

Wausau, Wisconsin, United States

Site Status

Aurora Cancer Care-Milwaukee West

Wauwatosa, 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

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, United States

Site Status

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Site Status

Centro Comprensivo de Cancer de UPR

San Juan, , Puerto Rico

Site Status

Countries

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

United States Canada Puerto Rico

Other Identifiers

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NCI-2016-00963

Identifier Type: REGISTRY

Identifier Source: secondary_id

NRG-GU002

Identifier Type: -

Identifier Source: secondary_id

NRG-GU002

Identifier Type: OTHER

Identifier Source: secondary_id

NRG-GU002

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180868

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NRG-GU002

Identifier Type: -

Identifier Source: org_study_id