Everolimus and Octreotide Acetate With or Without Bevacizumab in Treating Patients With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors That Cannot Be Removed by Surgery

NCT ID: NCT01229943

Last Updated: 2022-08-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-15

Study Completion Date

2018-01-03

Brief Summary

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This randomized phase II trial studies how well everolimus and octreotide acetate with or without bevacizumab works in treating patients with pancreatic neuroendocrine tumors that cannot be removed by surgery and have spread nearby or to other places in the body. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Octreotide acetate may interfere with and slow the growth of tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab and everolimus also may stop the growth of pancreatic neuroendocrine tumors by blocking blood flow to the tumor. It is not yet known whether giving everolimus and octreotide acetate together is more effective with or without bevacizumab in treating pancreatic neuroendocrine tumors.

Detailed Description

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PRIMARY OBJECTIVES:

l. To assess the progression-free survival rate of patients with locally advanced or metastatic pancreatic neuroendocrine tumors treated with everolimus alone or everolimus plus bevacizumab.

SECONDARY OBJECTIVES:

I. To compare progression-free survival (PFS) among treatment arms shown to be efficacious.

II. To estimate the overall tumor response rate in patients with metastatic pancreatic neuroendocrine tumors treated with one of two novel regimens.

III. To estimate the overall biochemical response rate (as measured by plasma chromogranin A levels) in patients with metastatic pancreatic neuroendocrine tumors treated with these regimens.

IV. To assess the toxicity of each regimen in patients with metastatic pancreatic neuroendocrine tumors.

V. To assess the overall survival of patients with pancreatic neuroendocrine tumors treated with these regimens.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive everolimus orally (PO) once daily (QD) on days 1-28 and octreotide acetate intramuscularly (IM) on day 1.

ARM II: Patients receive everolimus and octreotide acetate as in Arm I. Patients also receive bevacizumab intravenously (IV) over 30-90 minutes on days 1 and 15.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3-6 months for 3 years.

Conditions

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Advanced Pancreatic Neuroendocrine Tumor Locally Advanced Pancreatic Neuroendocrine Tumor Pancreatic Gastrinoma Pancreatic Neuroendocrine Tumor G1 Pancreatic Neuroendocrine Tumor G2 Pancreatic Vipoma

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 (octreotide acetate and everolimus)

Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1.

Group Type EXPERIMENTAL

Everolimus

Intervention Type DRUG

Given PO

Octreotide Acetate

Intervention Type DRUG

Given IM

Arm II (octreotide acetate, everolimus, and bevacizumab)

Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15.

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type BIOLOGICAL

Given IV

Everolimus

Intervention Type DRUG

Given PO

Octreotide Acetate

Intervention Type DRUG

Given IM

Interventions

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Bevacizumab

Given IV

Intervention Type BIOLOGICAL

Everolimus

Given PO

Intervention Type DRUG

Octreotide Acetate

Given IM

Intervention Type DRUG

Other Intervention Names

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ABP 215 Anti-VEGF Anti-VEGF Humanized Monoclonal Antibody Anti-VEGF Monoclonal Antibody SIBP04 Anti-VEGF rhuMAb Avastin Bevacizumab awwb Bevacizumab Biosimilar ABP 215 Bevacizumab Biosimilar BEVZ92 Bevacizumab Biosimilar BI 695502 Bevacizumab Biosimilar CBT 124 Bevacizumab Biosimilar CT-P16 Bevacizumab Biosimilar FKB238 Bevacizumab Biosimilar GB-222 Bevacizumab Biosimilar HD204 Bevacizumab Biosimilar HLX04 Bevacizumab Biosimilar IBI305 Bevacizumab Biosimilar LY01008 Bevacizumab Biosimilar MIL60 Bevacizumab Biosimilar Mvasi Bevacizumab Biosimilar MYL-1402O Bevacizumab Biosimilar QL 1101 Bevacizumab Biosimilar RPH-001 Bevacizumab Biosimilar SCT501 Bevacizumab Biosimilar Zirabev Bevacizumab-awwb Bevacizumab-bvzr BP102 BP102 Biosimilar HD204 Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer Mvasi MYL-1402O Recombinant Humanized Anti-VEGF Monoclonal Antibody rhuMab-VEGF SCT501 SIBP 04 SIBP-04 SIBP04 Zirabev 42-O-(2-Hydroxy)ethyl Rapamycin Afinitor Certican RAD 001 RAD001 Votubia Zortress D-Phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[(1R,2R)-2-hydroxy-1-(hyroxymethyl)propyl]-L-cysteinamide, Cyclic (2->7)-disulfide, Acetate (Salt) Longastatin Longastatina Samilstin Sandostatin Sandostatin Lar Depot Sandostatina Sandostatine SMS 201-995 SMS 201-995 AC

Eligibility Criteria

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Inclusion Criteria

* Patients must have histologic documentation of well-differentiated or moderately differentiated neuroendocrine tumor from either a primary or metastatic site

* If different histologic classification schemes are used, equivalent histologic classifications (for example "grade 1", "low-grade", or "intermediate-grade") are allowed
* Patients with poorly differentiated neuroendocrine carcinoma or small cell carcinoma are excluded
* Documentation from a metastatic disease site is sufficient if there is clinical evidence of a pancreatic primary site
* Locally unresectable or metastatic disease
* Patients must have either histologic documentation of a pancreatic primary site, or clinical evidence of a pancreatic neuroendocrine primary tumor as determined by the treating physician

* Patients with neuroendocrine tumors (e.g., gastrinoma, VIPoma) in whom a pancreatic or peripancreatic primary site is strongly suspected are also eligible
* Patients must have evidence of disease (measurable or non-measurable) with evidence of progression within the past 12 months
* Measurable disease:

Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 2 cm with conventional techniques or as \>= 1 cm with spiral computed tomography (CT) scan

* Non-measurable disease:

All other lesions, including small lesions (longest diameter \< 20 mm with conventional techniques or \< 10 mm with spiral CT scan) and truly non-measurable lesions; lesions that are considered non-measurable include the following:

* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Inflammatory breast disease
* Lymphangitis cutis/pulmonis
* Abdominal masses that are not confirmed and followed by imaging techniques
* Cystic lesions

* No prior treatment with bevacizumab, everolimus, or other mammalian target of rapamycin (mTOR) inhibitors
* Other prior treatments, including but not limited to prior cytotoxic chemotherapy, alpha interferon, tyrosine kinase inhibitors, external beam radiation therapy, and radiopeptide therapy are allowed
* There is no limit on the number of prior treatment regimens
* Any prior treatment (with the exception of octreotide) must be completed at least 4 weeks prior to initiation of treatment

* Prior treatment with embolization or ablative therapies is allowed if measurable disease remains outside of the treated area
* There is no limit on the prior number of procedures

* Treatment with somatostatin analogs is a requirement of the study
* Patients receiving octreotide at the time of study entry may continue at the same dose level for the duration of the study
* Patients not receiving octreotide will initiate treatment according to study guidelines
* Prior progression on somatostatin analogs or a negative octreotide scan does not exclude patient participation in this study

* Patients should have completed any major surgery \>= 4 weeks from start of treatment
* Patients must have completed any minor surgery \>= 2 weeks prior to start of treatment
* Patients must have fully recovered from the procedure
* Insertion of a vascular access device is not considered major or minor surgery

* Patients should not receive immunization with attenuated live vaccines within one week prior to registration or during protocol therapy
* No concurrent condition resulting in immune compromise, including chronic treatment with corticosteroids or other immuno suppressive agents
* No active or severe liver disease (e.g., acute or chronic hepatitis, cirrhosis); no positive anti-hepatitis B virus (HBV); HBV seropositive patients (hepatitis B surface antigen \[HBsAg\] positive) are eligible if they are closely monitored for evidence of active HBV infection by HBV deoxyribonucleic acid (DNA) testing, and they agree to receive suppressive therapy with lamivudine or other HBV-suppressive therapy until at least 4 weeks after the last dose of everolimus; patients who are hepatitis C antibody positive are eligible provided that hepatitis C viral load (hepatitis C ribonucleic acid \[RNA\]) is undetectable
* No clinical evidence of brain metastases or carcinomatous meningitis
* No history of gastrointestinal (GI) perforation within 12 months prior to registration
* No history of clinically significant bleeding episodes
* Patients on therapeutic anticoagulation are eligible for the study provided that they are on a stable dose of anticoagulants
* No uncontrolled diabetes mellitus
* Patients with a history of severely impaired lung function as defined as spirometry and diffusing capacity of the lung for carbon monoxide (DLCO) that is 50% of the normal predicted value and/or oxygen (O2) saturation that is 88% or less at rest on room air are excluded
* Patients with fasting serum cholesterol \>= 300 mg/dL OR \>= 7.75 mmol/L AND fasting triglycerides \>= 2.5 X upper limit of normal (ULN) should initiate lipid-lowering medications with the goal of achieving levels below these thresholds
* No history of intolerance or allergies to octreotide
* Patients with a history of hypertension must be adequately controlled (baseline blood pressure \[BP\] \< 150/90 mm Hg) on antihypertensives
* No current congestive heart failure (New York Heart Association class II, III, or IV)
* No symptomatic arterial peripheral vascular disease
* No history of aortic aneurysm, aortic dissection, angina, myocardial infarction, stroke, or other arterial thrombotic events within 6 months of registration
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Women must not be pregnant or lactating; both men and women of childbearing potential must be advised of the importance of using effective birth control measures during the course of the study
* Granulocytes \>= 1,500/uL
* Platelets \>= 100,000/uL
* Creatinine =\< 1.5 x upper limit of normal
* Bilirubin =\< 1.5 x upper limit of normal
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2.5 x upper limit of normal (=\< 5 x upper limit of normal if liver metastases present)
* Urine protein =\< 1+ OR urine creatinine ratio =\< 1 (by urinalysis)
* If urine protein creatinine (UPC) ratio is \> 1 on urinalysis, then 24-hour urine collection for protein must be obtained and level must be \< 1,000 mg for patient enrollment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew H Kulke

Role: PRINCIPAL_INVESTIGATOR

Alliance for Clinical Trials in Oncology

Locations

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Providence Hospital

Mobile, Alabama, United States

Site Status

Kaiser Permanente-Anaheim

Anaheim, California, United States

Site Status

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, United States

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Kaiser Permanente-Baldwin Park

Baldwin Park, California, United States

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Kaiser Permanente-Bellflower

Bellflower, California, United States

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Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

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Mills-Peninsula Medical Center

Burlingame, California, United States

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Kaiser Permanente-Fontana

Fontana, California, United States

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Kaiser Permanente-Fremont

Fremont, California, United States

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Kaiser Permanente-Fresno

Fresno, California, United States

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Kaiser Permanente - Harbor City

Harbor City, California, United States

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Kaiser Permanente-Irvine

Irvine, California, United States

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Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

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Kaiser Permanente West Los Angeles

Los Angeles, California, United States

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Cedars Sinai Medical Center

Los Angeles, California, United States

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Sutter Cancer Research Consortium

Novato, California, United States

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Kaiser Permanente-Oakland

Oakland, California, United States

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Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

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Kaiser Permanente - Panorama City

Panorama City, 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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Kaiser Permanente-Riverside

Riverside, California, United States

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Kaiser Permanente-Roseville

Roseville, California, United States

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Kaiser Permanente-South Sacramento

Sacramento, California, United States

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Kaiser Permanente - Sacramento

Sacramento, California, United States

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Kaiser Permanente-San Diego Mission

San Diego, California, United States

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Kaiser Permanente-San Diego Zion

San Diego, California, United States

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California Pacific Medical Center-Pacific Campus

San Francisco, California, United States

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Kaiser Permanente-San Francisco

San Francisco, California, United States

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UCSF Medical Center-Mount Zion

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 Marcos

San Marcos, California, United States

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Kaiser Permanente-San Rafael

San Rafael, California, United States

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Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

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Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Site Status

Sutter Pacific Medical Foundation

Santa Rosa, California, United States

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Kaiser Permanente-South San Francisco

South San Francisco, California, United States

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Kaiser Permanente-Stockton

Stockton, California, United States

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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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Kaiser Permanente-Woodland Hills

Woodland Hills, California, United States

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The Medical Center of Aurora

Aurora, Colorado, United States

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Boulder Community Hospital

Boulder, Colorado, United States

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Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

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Porter Adventist Hospital

Denver, Colorado, United States

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Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

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SCL Health Saint Joseph Hospital

Denver, Colorado, United States

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Rose Medical Center

Denver, Colorado, United States

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Western States Cancer Research NCORP

Denver, Colorado, United States

Site Status

Swedish Medical Center

Englewood, Colorado, United States

Site Status

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

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North Colorado Medical Center

Greeley, Colorado, United States

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Saint Anthony Hospital

Lakewood, Colorado, United States

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Littleton Adventist Hospital

Littleton, Colorado, United States

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Sky Ridge Medical Center

Lone Tree, Colorado, United States

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Longmont United Hospital

Longmont, Colorado, United States

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McKee Medical Center

Loveland, Colorado, United States

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Parker Adventist Hospital

Parker, Colorado, United States

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Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

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North Suburban Medical Center

Thornton, Colorado, United States

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SCL Health Lutheran Medical Center

Wheat Ridge, Colorado, United States

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Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, United States

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The Hospital of Central Connecticut

New Britain, Connecticut, United States

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Beebe Medical Center

Lewes, Delaware, United States

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Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

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MedStar Georgetown University Hospital

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

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MedStar Washington Hospital Center

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

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Lakeland Regional Health Hollis Cancer Center

Lakeland, Florida, United States

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AdventHealth Orlando

Orlando, Florida, United States

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Augusta University Medical Center

Augusta, Georgia, United States

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Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, United States

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Queen's Medical Center

Honolulu, Hawaii, United States

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Straub Clinic and Hospital

Honolulu, Hawaii, United States

Site Status

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

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Hawaii Cancer Care Inc-Liliha

Honolulu, Hawaii, United States

Site Status

Queen's Cancer Center - Kuakini

Honolulu, Hawaii, United States

Site Status

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, United States

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Kaiser Permanente Moanalua Medical Center

Honolulu, Hawaii, United States

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Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

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Castle Medical Center

Kailua, Hawaii, United States

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Wilcox Memorial Hospital and Kauai Medical Clinic

Lihue, Hawaii, United States

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Maui Memorial Medical Center

Wailuku, Hawaii, United States

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Pacific Cancer Institute of Maui

Wailuku, Hawaii, United States

Site Status

Pali Momi Medical Center

‘Aiea, Hawaii, United States

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Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

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Hematology and Oncology Associates

Chicago, Illinois, United States

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Northwestern University

Chicago, Illinois, United States

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University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

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Advocate Sherman Hospital

Elgin, Illinois, United States

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Hematology Oncology Associates of Illinois-Highland Park

Highland Park, Illinois, United States

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Presence Saint Mary's Hospital

Kankakee, Illinois, United States

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AMITA Health Adventist Medical Center

La Grange, Illinois, United States

Site Status

AMG Libertyville - Oncology

Libertyville, Illinois, United States

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Loyola University Medical Center

Maywood, Illinois, United States

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Garneau, Stewart C MD (UIA Investigator)

Moline, Illinois, United States

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Porubcin, Michael MD (UIA Investigator)

Moline, Illinois, United States

Site Status

Spector, David MD (UIA Investigator)

Moline, Illinois, United States

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Trinity Medical Center

Moline, Illinois, United States

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Illinois Cancer Specialists-Niles

Niles, Illinois, United States

Site Status

Swedish American Hospital

Rockford, Illinois, United States

Site Status

Hematology Oncology Associates of Illinois - Skokie

Skokie, Illinois, United States

Site Status

Franciscan Saint Francis Health-Beech Grove

Beech Grove, Indiana, United States

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Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

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Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, United States

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Reid Health

Richmond, Indiana, United States

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McFarland Clinic PC - Ames

Ames, Iowa, United States

Site Status

Constantinou, Costas L MD (UIA Investigator)

Bettendorf, Iowa, United States

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Medical Oncology and Hematology Associates-West Des Moines

Clive, Iowa, United States

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Mercy Cancer Center-West Lakes

Clive, Iowa, United States

Site Status

Iowa Methodist Medical Center

Des Moines, Iowa, United States

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Iowa-Wide Oncology Research Coalition NCORP

Des Moines, Iowa, United States

Site Status

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, United States

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Medical Oncology and Hematology Associates-Laurel

Des Moines, Iowa, United States

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Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

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Iowa Lutheran Hospital

Des Moines, Iowa, United States

Site Status

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Site Status

Ottumwa Regional Health Center

Ottumwa, Iowa, United States

Site Status

Siouxland Regional Cancer Center

Sioux City, Iowa, United States

Site Status

Mercy Medical Center-Sioux City

Sioux City, Iowa, United States

Site Status

Saint Luke's Regional Medical Center

Sioux City, Iowa, United States

Site Status

Methodist West Hospital

West Des Moines, Iowa, United States

Site Status

Mercy Medical Center-West Lakes

West Des Moines, Iowa, United States

Site Status

Cancer Center of Kansas - Chanute

Chanute, Kansas, United States

Site Status

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, United States

Site Status

Cancer Center of Kansas - El Dorado

El Dorado, Kansas, United States

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Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, United States

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Cancer Center of Kansas-Independence

Independence, Kansas, United States

Site Status

Cancer Center of Kansas-Kingman

Kingman, Kansas, United States

Site Status

Lawrence Memorial Hospital

Lawrence, Kansas, United States

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Cancer Center of Kansas-Liberal

Liberal, Kansas, United States

Site Status

Cancer Center of Kansas - McPherson

McPherson, Kansas, United States

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Cancer Center of Kansas - Newton

Newton, Kansas, United States

Site Status

Menorah Medical Center

Overland Park, Kansas, United States

Site Status

Saint Luke's South Hospital

Overland Park, Kansas, United States

Site Status

Cancer Center of Kansas - Parsons

Parsons, Kansas, United States

Site Status

Kansas City NCI Community Oncology Research Program

Prairie Village, Kansas, United States

Site Status

Cancer Center of Kansas - Pratt

Pratt, Kansas, United States

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Cancer Center of Kansas - Salina

Salina, Kansas, United States

Site Status

Cotton O'Neil Cancer Center / Stormont Vail Health

Topeka, Kansas, United States

Site Status

Cancer Center of Kansas - Wellington

Wellington, Kansas, United States

Site Status

Associates In Womens Health

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, United States

Site Status

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas - Wichita

Wichita, Kansas, United States

Site Status

Wichita NCI Community Oncology Research Program

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas - Winfield

Winfield, Kansas, United States

Site Status

Ochsner Health Center-Summa

Baton Rouge, Louisiana, United States

Site Status

Ochsner Health Center-Covington

Covington, Louisiana, United States

Site Status

Ochsner Baptist Medical Center

New Orleans, Louisiana, United States

Site Status

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

Site Status

Mercy Medical Center

Baltimore, Maryland, United States

Site Status

Christiana Care - Union Hospital

Elkton, Maryland, United States

Site Status

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Bixby Medical Center

Adrian, Michigan, United States

Site Status

Hickman Cancer Center

Adrian, Michigan, United States

Site Status

Michigan Cancer Research Consortium NCORP

Ann Arbor, Michigan, United States

Site Status

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Site Status

Bronson Battle Creek

Battle Creek, Michigan, United States

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Spectrum Health Big Rapids Hospital

Big Rapids, Michigan, United States

Site Status

Beaumont Hospital - Dearborn

Dearborn, Michigan, United States

Site Status

Ascension Saint John Hospital

Detroit, Michigan, United States

Site Status

Green Bay Oncology - Escanaba

Escanaba, Michigan, United States

Site Status

Hurley Medical Center

Flint, Michigan, United States

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Genesys Regional Medical Center-West Flint Campus

Flint, Michigan, United States

Site Status

Genesys Regional Medical Center

Grand Blanc, Michigan, United States

Site Status

Cancer Research Consortium of West Michigan NCORP

Grand Rapids, Michigan, United States

Site Status

Mercy Health Saint Mary's

Grand Rapids, Michigan, United States

Site Status

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, United States

Site Status

Green Bay Oncology - Iron Mountain

Iron Mountain, Michigan, United States

Site Status

Allegiance Health

Jackson, Michigan, United States

Site Status

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Site Status

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status

Borgess Medical Center

Kalamazoo, Michigan, United States

Site Status

Sparrow Hospital

Lansing, Michigan, United States

Site Status

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Site Status

Mercy Memorial Hospital

Monroe, Michigan, United States

Site Status

Toledo Clinic Cancer Centers-Monroe

Monroe, Michigan, United States

Site Status

Mercy Health Mercy Campus

Muskegon, Michigan, United States

Site Status

Saint Joseph Mercy Oakland

Pontiac, Michigan, United States

Site Status

Lake Huron Medical Center

Port Huron, Michigan, United States

Site Status

Spectrum Health Reed City Hospital

Reed City, Michigan, United States

Site Status

William Beaumont Hospital-Royal Oak

Royal Oak, Michigan, United States

Site Status

Ascension Saint Mary's Hospital

Saginaw, Michigan, United States

Site Status

Munson Medical Center

Traverse City, Michigan, United States

Site Status

Saint John Macomb-Oakland Hospital

Warren, Michigan, United States

Site Status

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States

Site Status

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, United States

Site Status

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Site Status

Mercy Hospital

Coon Rapids, Minnesota, United States

Site Status

Essentia Health Cancer Center

Duluth, Minnesota, United States

Site Status

Essentia Health Saint Mary's Medical Center

Duluth, Minnesota, United States

Site Status

Miller-Dwan Hospital

Duluth, Minnesota, United States

Site Status

Fairview Southdale Hospital

Edina, Minnesota, United States

Site Status

Lake Region Healthcare Corporation-Cancer Care

Fergus Falls, Minnesota, United States

Site Status

Unity Hospital

Fridley, Minnesota, United States

Site Status

Hutchinson Area Health Care

Hutchinson, 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

Site Status

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

New Ulm Medical Center

New Ulm, Minnesota, United States

Site Status

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Site Status

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Metro Minnesota Community Oncology Research Consortium

Saint Louis Park, 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

United Hospital

Saint Paul, Minnesota, United States

Site Status

Saint Francis Regional Medical Center

Shakopee, Minnesota, United States

Site Status

Lakeview Hospital

Stillwater, Minnesota, United States

Site Status

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

Southeast Cancer Center

Cape Girardeau, Missouri, United States

Site Status

University of Missouri - Ellis Fischel

Columbia, Missouri, United States

Site Status

Capital Region Southwest Campus

Jefferson City, Missouri, United States

Site Status

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Site Status

North Kansas City Hospital

Kansas City, Missouri, United States

Site Status

Heartland Hematology and Oncology Associates Incorporated

Kansas City, Missouri, United States

Site Status

Research Medical Center

Kansas City, Missouri, United States

Site Status

Saint Luke's East - Lee's Summit

Lee's Summit, Missouri, United States

Site Status

Liberty Radiation Oncology Center

Liberty, Missouri, United States

Site Status

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

Site Status

Saint Joseph Oncology Inc

Saint Joseph, Missouri, United States

Site Status

SSM Health Saint Louis University Hospital

St Louis, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Missouri Baptist Medical Center

St Louis, Missouri, United States

Site Status

Comprehensive Cancer Care PC

St Louis, Missouri, United States

Site Status

Billings Clinic Cancer Center

Billings, Montana, United States

Site Status

Saint Vincent Healthcare

Billings, Montana, United States

Site Status

Montana Cancer Consortium NCORP

Billings, Montana, United States

Site Status

Saint Vincent Frontier Cancer Center

Billings, Montana, United States

Site Status

Bozeman Deaconess Hospital

Bozeman, Montana, United States

Site Status

Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, United States

Site Status

Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, United States

Site Status

Great Falls Clinic

Great Falls, Montana, United States

Site Status

Northern Montana Hospital

Havre, Montana, United States

Site Status

Saint Peter's Community Hospital

Helena, Montana, United States

Site Status

Glacier Oncology PLLC

Kalispell, Montana, United States

Site Status

Kalispell Medical Oncology

Kalispell, Montana, United States

Site Status

Kalispell Regional Medical Center

Kalispell, Montana, United States

Site Status

Montana Cancer Specialists

Missoula, Montana, United States

Site Status

Saint Patrick Hospital - Community Hospital

Missoula, Montana, United States

Site Status

CHI Health Saint Francis

Grand Island, Nebraska, United States

Site Status

Great Plains Health Callahan Cancer Center

North Platte, Nebraska, United States

Site Status

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Norris Cotton Cancer Center-Manchester

Manchester, New Hampshire, United States

Site Status

Cooper Hospital University Medical Center

Camden, New Jersey, United States

Site Status

Rutgers New Jersey Medical School

Newark, New Jersey, United States

Site Status

New York Oncology Hematology PC - Albany

Albany, New York, United States

Site Status

New York Oncology Hematology PC - Albany Medical Center

Albany, New York, United States

Site Status

New York Oncology Hematology PC - Amsterdam

Amsterdam, New York, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

New York Oncology Hematology PC - Clifton Park

Clifton Park, New York, United States

Site Status

Hematology Oncology Associates of Central New York-East Syracuse

East Syracuse, New York, United States

Site Status

Glens Falls Hospital

Glens Falls, New York, United States

Site Status

New York Oncology Hematology PC-Hudson

Hudson, New York, United States

Site Status

Garnet Health Medical Center

Middletown, New York, United States

Site Status

New York Oncology Hematology PC - Troy

Troy, New York, United States

Site Status

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, United States

Site Status

Wayne Memorial Hospital

Goldsboro, North Carolina, United States

Site Status

Iredell Memorial Hospital

Statesville, North Carolina, United States

Site Status

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Mid Dakota Clinic

Bismarck, North Dakota, United States

Site Status

Saint Alexius Medical Center

Bismarck, North Dakota, United States

Site Status

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States

Site Status

Sanford Broadway Medical Center

Fargo, North Dakota, United States

Site Status

Mary Rutan Hospital

Bellefontaine, Ohio, United States

Site Status

Toledo Clinic Cancer Centers-Bowling Green

Bowling Green, Ohio, United States

Site Status

Adena Regional Medical Center

Chillicothe, Ohio, United States

Site Status

North Coast Cancer Care-Clyde

Clyde, Ohio, United States

Site Status

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Riverside Methodist Hospital

Columbus, Ohio, United States

Site Status

Columbus NCI Community Oncology Research Program

Columbus, Ohio, United States

Site Status

Grant Medical Center

Columbus, Ohio, United States

Site Status

Mount Carmel Health Center West

Columbus, Ohio, United States

Site Status

Doctors Hospital

Columbus, Ohio, United States

Site Status

Grandview Hospital

Dayton, Ohio, United States

Site Status

Good Samaritan Hospital - Dayton

Dayton, Ohio, United States

Site Status

Miami Valley Hospital

Dayton, Ohio, United States

Site Status

Miami Valley Hospital North

Dayton, Ohio, United States

Site Status

Dayton NCI Community Oncology Research Program

Dayton, Ohio, United States

Site Status

Grady Memorial Hospital

Delaware, Ohio, United States

Site Status

Hematology Oncology Center Incorporated

Elyria, Ohio, United States

Site Status

Mercy Cancer Center-Elyria

Elyria, Ohio, United States

Site Status

Blanchard Valley Hospital

Findlay, Ohio, United States

Site Status

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, United States

Site Status

Wayne Hospital

Greenville, Ohio, United States

Site Status

Kettering Medical Center

Kettering, Ohio, United States

Site Status

Fairfield Medical Center

Lancaster, Ohio, United States

Site Status

Lima Memorial Hospital

Lima, Ohio, United States

Site Status

Marietta Memorial Hospital

Marietta, Ohio, United States

Site Status

Saint Luke's Hospital

Maumee, Ohio, United States

Site Status

Toledo Clinic Cancer Centers-Maumee

Maumee, Ohio, United States

Site Status

Toledo Radiation Oncology at Northwest Ohio Onocolgy Center

Maumee, Ohio, United States

Site Status

Knox Community Hospital

Mount Vernon, Ohio, United States

Site Status

Licking Memorial Hospital

Newark, Ohio, United States

Site Status

Fisher-Titus Medical Center

Norwalk, Ohio, United States

Site Status

Saint Charles Hospital

Oregon, Ohio, United States

Site Status

Toledo Clinic Cancer Centers-Oregon

Oregon, Ohio, United States

Site Status

Southern Ohio Medical Center

Portsmouth, Ohio, United States

Site Status

North Coast Cancer Care

Sandusky, Ohio, United States

Site Status

Springfield Regional Medical Center

Springfield, Ohio, United States

Site Status

ProMedica Flower Hospital

Sylvania, Ohio, United States

Site Status

Mercy Hospital of Tiffin

Tiffin, Ohio, United States

Site Status

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo, Ohio, United States

Site Status

Saint Vincent Mercy Medical Center

Toledo, Ohio, United States

Site Status

University of Toledo

Toledo, Ohio, United States

Site Status

Toledo Community Hospital Oncology Program CCOP

Toledo, Ohio, United States

Site Status

Mercy Health - Saint Anne Hospital

Toledo, Ohio, United States

Site Status

Toledo Clinic Cancer Centers-Toledo

Toledo, Ohio, United States

Site Status

Upper Valley Medical Center

Troy, Ohio, United States

Site Status

Fulton County Health Center

Wauseon, Ohio, United States

Site Status

Saint Ann's Hospital

Westerville, Ohio, United States

Site Status

Clinton Memorial Hospital

Wilmington, Ohio, United States

Site Status

Greene Memorial Hospital

Xenia, Ohio, United States

Site Status

Genesis Healthcare System Cancer Care Center

Zanesville, Ohio, United States

Site Status

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Clackamas Radiation Oncology Center

Clackamas, Oregon, United States

Site Status

Providence Milwaukie Hospital

Milwaukie, Oregon, United States

Site Status

Providence Newberg Medical Center

Newberg, Oregon, United States

Site Status

Providence Willamette Falls Medical Center

Oregon City, Oregon, United States

Site Status

Providence Portland Medical Center

Portland, Oregon, United States

Site Status

Adventist Medical Center

Portland, Oregon, United States

Site Status

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Site Status

Butler Memorial Hospital

Butler, Pennsylvania, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Geisinger Medical Center-Cancer Center Hazleton

Hazleton, Pennsylvania, United States

Site Status

Pottstown Hospital

Pottstown, Pennsylvania, United States

Site Status

Geisinger Medical Group

State College, Pennsylvania, United States

Site Status

Reading Hospital

West Reading, Pennsylvania, United States

Site Status

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

Site Status

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, United States

Site Status

Roper Hospital

Charleston, South Carolina, United States

Site Status

Saint Francis Hospital

Greenville, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States

Site Status

Prisma Health Greenville Memorial Hospital

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

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, United States

Site Status

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Site Status

Avera McKennan Hospital and University Health Center

Sioux Falls, South Dakota, United States

Site Status

Thompson Cancer Survival Center

Knoxville, Tennessee, United States

Site Status

University of Tennessee - Knoxville

Knoxville, Tennessee, United States

Site Status

The Don and Sybil Harrington Cancer Center

Amarillo, Texas, United States

Site Status

Parkland Memorial Hospital

Dallas, Texas, United States

Site Status

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Site Status

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Site Status

Fredericksburg Oncology Inc

Fredericksburg, Virginia, United States

Site Status

Cancer Care Center at Island Hospital

Anacortes, Washington, United States

Site Status

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, United States

Site Status

Harrison HealthPartners Hematology and Oncology-Bremerton

Bremerton, Washington, United States

Site Status

Highline Medical Center-Main Campus

Burien, Washington, United States

Site Status

Swedish Cancer Institute-Issaquah

Issaquah, Washington, United States

Site Status

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, United States

Site Status

Skagit Valley Hospital

Mount Vernon, Washington, United States

Site Status

Harrison HealthPartners Hematology and Oncology-Poulsbo

Poulsbo, Washington, United States

Site Status

Harborview Medical Center

Seattle, Washington, United States

Site Status

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Kaiser Permanente Washington

Seattle, Washington, United States

Site Status

Swedish Medical Center-First Hill

Seattle, Washington, United States

Site Status

University of Washington Medical Center - Montlake

Seattle, Washington, United States

Site Status

PeaceHealth United General Medical Center

Sedro-Woolley, Washington, United States

Site Status

Cancer Care Northwest - Spokane South

Spokane, Washington, United States

Site Status

Evergreen Hematology and Oncology PS

Spokane, Washington, United States

Site Status

PeaceHealth Southwest Medical Center

Vancouver, Washington, United States

Site Status

Compass Oncology Vancouver

Vancouver, Washington, United States

Site Status

Wenatchee Valley Hospital and Clinics

Wenatchee, Washington, United States

Site Status

Green Bay Oncology at Saint Vincent Hospital

Green Bay, Wisconsin, United States

Site Status

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, United States

Site Status

Green Bay Oncology Limited at Saint Mary's Hospital

Green Bay, Wisconsin, United States

Site Status

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, United States

Site Status

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Site Status

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, United States

Site Status

Holy Family Memorial Hospital

Manitowoc, Wisconsin, United States

Site Status

Bay Area Medical Center

Marinette, Wisconsin, United States

Site Status

Saint Vincent Hospital Cancer Center at Oconto Falls

Oconto Falls, Wisconsin, United States

Site Status

HSHS Saint Nicholas Hospital

Sheboygan, Wisconsin, United States

Site Status

Green Bay Oncology - Sturgeon Bay

Sturgeon Bay, Wisconsin, United States

Site Status

Rocky Mountain Oncology

Casper, Wyoming, United States

Site Status

Welch Cancer Center

Sheridan, Wyoming, United States

Site Status

BCCA-Vancouver Cancer Centre

Vancouver, British Columbia, Canada

Site Status

The Vitalite Health Network - Dr Leon Richard Oncology Centre

Moncton, New Brunswick, Canada

Site Status

QEII Health Sciences Centre/Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

Site Status

Ottawa Hospital and Cancer Center-General Campus

Ottawa, Ontario, Canada

Site Status

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Allan Blair Cancer Centre

Regina, 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-2011-02609

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000687459

Identifier Type: -

Identifier Source: secondary_id

CALGB-80701

Identifier Type: -

Identifier Source: secondary_id

CALGB-80701

Identifier Type: OTHER

Identifier Source: secondary_id

CALGB-80701

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180821

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10CA031946

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2011-02609

Identifier Type: -

Identifier Source: org_study_id

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