Carboplatin, Paclitaxel, and Bevacizumab With or Without Everolimus in Treating Patients With Metastatic Malignant Melanoma

NCT ID: NCT00976573

Last Updated: 2017-04-04

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

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2015-09-30

Brief Summary

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This randomized phase II trial is studying how well carboplatin, paclitaxel, and bevacizumab work when given with or without everolimus in treating patients with malignant melanoma that has spread from where it started to other places in the body. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may block the ability of tumor cells to grow and spread. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether combination chemotherapy given together with bevacizumab is more effective with or without everolimus in treating patients with metastatic melanoma.

Detailed Description

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OBJECTIVES:

Primary

* To assess whether there is sufficient promise of an impact of the addition of everolimus to the combination of carboplatin, paclitaxel, and bevacizumab on progression-free survival that it would be recommended for further testing in patients with metastatic malignant melanoma.

Secondary

* To estimate the confirmed tumor response rate of each of the treatment regimens.
* To estimate the distribution of overall survival (OS) time for each of the treatment regimens.
* To assess the impact on the safety profile of the addition of everolimus to the combination of carboplatin, paclitaxel, and bevacizumab.

OUTLINE: This is a multicenter study. Patients are stratified according to elevated LDH (above upper limit of normal) at baseline (yes vs no), location of metastatic disease (M1a \[skin, subcutaneous tissue, or lymph node only\] vs M1b \[lung\] vs M1c \[other visceral sites\]) and prior chemotherapy for metastatic disease (yes vs no). Patients are randomized to 1 of 2 treatment arms.

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

ARM I: Patients receive bevacizumab intravenously (IV) over 30-90 minutes on days 1 and 15, paclitaxel IV over 60 minutes on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive everolimus orally (PO) once daily (QD) 3 times weekly. 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 up to 5 years.

Conditions

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Melanoma (Skin)

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 (bevacizumab, paclitaxel, and carboplatin)

Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, paclitaxel IV over 60 minutes on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

bevacizumab

Intervention Type BIOLOGICAL

Given IV

carboplatin

Intervention Type DRUG

Given IV

paclitaxel

Intervention Type DRUG

Given IV

Arm II(bevacizumab, paclitaxel, carboplatin, and everolimus)

Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive everolimus PO QD on 3 days a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

bevacizumab

Intervention Type BIOLOGICAL

Given IV

carboplatin

Intervention Type DRUG

Given IV

everolimus

Intervention Type DRUG

Given orally

paclitaxel

Intervention Type DRUG

Given IV

Interventions

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bevacizumab

Given IV

Intervention Type BIOLOGICAL

carboplatin

Given IV

Intervention Type DRUG

everolimus

Given orally

Intervention Type DRUG

paclitaxel

Given IV

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologic proof of stage IV malignant melanoma not amenable to surgery; (biopsy can be of locoregional disease in setting of clinically evident stage IV disease, but primary tumor alone will not qualify)
* At most one prior chemotherapy based regimen for metastatic melanoma (no prior taxane-based regimens allowed); note: prior adjuvant non-taxane based chemotherapy and/or adjuvant immunotherapy are allowed; no limit on the number of prior biologic, immunologic or targeted therapies
* Measurable disease defined as at least one lesion whose longest diameter can be accurately measured as \>= 2.0 cm with chest x-ray, or as \>= 1.0 cm with computed tomography (CT) scan, CT component of a positron emission tomography (PET)/CT, or magnetic resonance imaging (MRI) scan; note: disease that is measurable by physical examination only is not eligible
* Life expectancy \>= 4 months
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Absolute neutrophil count (ANC) \>= 1500/mL
* Platelets (PLT) \>= 100,000 x 10\^9/L
* Hemoglobin (Hgb) \>= 9 g/dL (patients may be transfused to meet this requirement)
* Total cholesterol =\< 300 mg/dL and; (note: serum levels of cholesterol or triglycerides found to be elevated may be lowered with anti-lipid therapy, but must be documented to be below these levels prior to enrollment)
* Triglycerides =\< 2.5 X upper limit of normal (ULN); (note: serum levels of cholesterol or triglycerides found to be elevated may be lowered with anti-lipid therapy, but must be documented to be below these levels prior to enrollment)
* Creatinine =\< 1.5 x ULN
* Total bilirubin =\< 1.5 mg/dL (exception: patients with documented Gilbert's syndrome are allowed to participate despite elevated bilirubin)
* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 2.5 x ULN
* Alkaline phosphatase =\< 2.5 x ULN
* Urine protein:creatinine (UPC) ratio \< 1.0 at screening OR
* Urine dipstick for proteinuria \< 2+ (patients discovered to have \>= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate =\< 1 g of protein in 24 hours to be eligible)
* Negative pregnancy test done =\< 7 days prior to registration/randomization, for women of childbearing potential only
* Ability to understand and the willingness to sign a written informed consent document
* Willing to return to a North Central Cancer Treatment Group (NCCTG) institution for follow-up
* Willing to provide mandatory blood samples for research purposes
* Willing to follow a diet low in fat and cholesterol while taking everolimus
* Willing to abstain from eating grapefruit or drinking grapefruit juice for the duration of the study

Exclusion Criteria

* Prior treatment with agents disrupting vascular endothelial growth factor (VEGF) activity (i.e., bevacizumab, VEGF-trap, anti-VEGF receptor \[R\] monoclonal antibody \[Mab\]) or targeting VEGFR (e.g. sunitinib, sorafenib)
* Prior treatment with an mTOR inhibitor for melanoma (sirolimus, temsirolimus, everolimus)
* Brain metastases per MRI or CT at any time prior to registration; note: patients that have had primary therapy for brain metastasis (i.e. surgical resection, whole brain radiation, or stereotactic radiation therapy \[SRT\] even if stable) are not eligible
* Other investigational agents =\< 4 weeks prior to registration/randomization
* Chemotherapy treatment =\< 3 weeks prior to registration/randomization
* Any biologic, immunologic or targeted therapy =\< 2 weeks prior to registration/randomization
* Major surgical procedure, open biopsy, or significant traumatic injury =\< 4 weeks prior to registration/randomization
* Fine needle aspirations or core biopsies =\< 7 days prior to registration/randomization
* Planned/or anticipated major surgical procedure during the course of the study
* Other medical conditions including but not limited to:

* History of liver disease such as cirrhosis, chronic active hepatitis, chronic persistent hepatitis or hepatitis B or C
* Active infection requiring parenteral antibiotics
* Poorly controlled high blood pressure (\>=150 mm Hg systolic and/or 100 mmHg diastolic) despite treatment
* New York Heart Association class II-IV congestive heart failure
* Serious cardiac arrhythmia requiring medication
* Myocardial infarction or unstable angina =\< 6 months prior to registration/randomization
* Clinically significant peripheral vascular disease
* Deep venous thrombosis or pulmonary embolus =\< 1 year of registration/randomization and/or ongoing need for full-dose oral or parenteral anticoagulation
* Ongoing anti-platelet treatment other than low-dose aspirin (i.e., aspirin 81 mg orally \[p.o.\] daily)
* Active bleeding or pathological conditions that carry high risk of bleeding (e.g., known esophageal varices, etc.)
* Serious, non-healing wound (including wounds healing by secondary intention), ulcer or bone fracture
* History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess =\< 6 months prior to registration/randomization
* History of central nervous system (CNS) disease (e.g., primary brain tumor, vascular abnormalities, etc.), clinically significant stroke or transient ischemic attack (TIA) =\< 6 months prior to registration/randomization, seizures not controlled with standard medical therapy
* Radiographically documented tumor invading major blood vessels
* History of hypertensive crisis or hypertensive encephalopathy
* Uncontrolled diabetes as defined by fasting serum glucose \> 1.5 x ULN
* 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 02 saturation that is 88% or less at rest on room air
* A known history of human immunodeficiency virus (HIV) seropositivity
* Any of the following as this regimen may be harmful to a developing fetus or nursing child:

* Pregnant women
* Nursing women
* Men and women of reproductive potential who are not using effective birth control methods must use highly effective contraception throughout the trail and for 6 months after last study treatment
* Existence of peripheral sensory neuropathy \>= grade 2
* History of other malignancy =\< 5 years with the exception of basal cell or squamous cell carcinoma of the skin, treated with local resection only, or carcinoma in situ (e.g. of the cervix, breast, prostate, etc.)
* =\< 4 weeks since last day of adjuvant radiation therapy prior to registration or =\< 2 weeks since last day of palliative radiation therapy; NOTE: patients who have had \> 25% of their functional bone marrow irradiated are not eligible for this trial
* Active or recent history of hemoptysis (\>= 1/2 teaspoon of bright red blood per episode) =\< 30 days prior to registration
* Known hypersensitivity to any of the components of the everolimus, bevacizumab, carboplatin, or paclitaxel
* Current use of drugs that are known to be strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4); note: if these agents are discontinued, everolimus therapy can begin \>= 7 days after discontinuation of such agent
* Positive hepatitis B antigen (HBsAg) or hepatitis C serology (HCV) tests
* Planned immunization with attenuated live vaccines =\< 7 days prior to registration or during study period; note: close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus; examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, Bacillus Calmette-Guérin (BCG), yellow fever, varicella and TY21a typhoid vaccines
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert McWilliams, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

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Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

Contra Costa Regional Medical Center

Martinez, California, United States

Site Status

El Camino Hospital Cancer Center

Mountain View, California, United States

Site Status

Bay Area Breast Surgeons, Incorporated

Oakland, California, United States

Site Status

CCOP - Bay Area Tumor Institute

Oakland, California, United States

Site Status

Larry G Strieff MD Medical Corporation

Oakland, California, United States

Site Status

Tom K Lee, Incorporated

Oakland, California, United States

Site Status

Doctors Medical Center - San Pablo Campus

San Pablo, California, United States

Site Status

Aurora Presbyterian Hospital

Aurora, Colorado, United States

Site Status

Boulder Community Hospital

Boulder, Colorado, United States

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Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, United States

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St. Anthony Central Hospital

Denver, Colorado, United States

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Porter Adventist Hospital

Denver, Colorado, United States

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Presbyterian - St. Luke's Medical Center

Denver, Colorado, United States

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St. Joseph Hospital

Denver, Colorado, United States

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Rose Medical Center

Denver, Colorado, United States

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Swedish Medical Center

Englewood, Colorado, United States

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Poudre Valley Hospital

Fort Collins, Colorado, United States

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Front Range Cancer Specialists

Fort Collins, Colorado, United States

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North Colorado Medical Center

Greeley, Colorado, United States

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Sky Ridge Medical Center

Lone Tree, Colorado, United States

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Hope Cancer Care Center at Longmont United Hospital

Longmont, Colorado, United States

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McKee Medical Center

Loveland, Colorado, United States

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St. Mary - Corwin Regional Medical Center

Pueblo, Colorado, United States

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North Suburban Medical Center

Thornton, Colorado, United States

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Exempla Lutheran Medical Center

Wheat Ridge, Colorado, United States

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Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

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Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

Fort Lauderdale, Florida, United States

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Baptist Cancer Institute - Jacksonville

Jacksonville, Florida, United States

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Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status

Ella Milbank Foshay Cancer Center at Jupiter Medical Center

Jupiter, Florida, United States

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Lakeland Regional Cancer Center at Lakeland Regional Medical Center

Lakeland, Florida, United States

Site Status

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, United States

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John B. Amos Cancer Center

Columbus, Georgia, United States

Site Status

Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

Boise, Idaho, United States

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Rush-Copley Cancer Care Center

Aurora, Illinois, United States

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Illinois CancerCare - Bloomington

Bloomington, Illinois, United States

Site Status

St. Joseph Medical Center

Bloomington, Illinois, United States

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Illinois CancerCare - Canton

Canton, Illinois, United States

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Illinois CancerCare - Carthage

Carthage, Illinois, United States

Site Status

Eureka Community Hospital

Eureka, Illinois, United States

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Illinois CancerCare - Eureka

Eureka, Illinois, United States

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Galesburg Clinic, PC

Galesburg, Illinois, United States

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Illinois CancerCare - Havana

Havana, Illinois, United States

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Illinois CancerCare - Kewanee Clinic

Kewanee, Illinois, United States

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La Grange Memorial Hospital

La Grange, Illinois, United States

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Illinois CancerCare - Macomb

Macomb, Illinois, United States

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Trinity Cancer Center at Trinity Medical Center - 7th Street Campus

Moline, Illinois, United States

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Moline, Illinois, United States

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Illinois CancerCare - Monmouth

Monmouth, Illinois, United States

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OSF Holy Family Medical Center

Monmouth, Illinois, United States

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BroMenn Regional Medical Center

Normal, Illinois, United States

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Community Cancer Center

Normal, Illinois, United States

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Illinois CancerCare - Community Cancer Center

Normal, Illinois, United States

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Community Hospital of Ottawa

Ottawa, Illinois, United States

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Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, United States

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Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, United States

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Illinois CancerCare - Pekin

Pekin, Illinois, United States

Site Status

Proctor Hospital

Peoria, Illinois, United States

Site Status

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

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Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, United States

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Methodist Medical Center of Illinois

Peoria, Illinois, United States

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OSF St. Francis Medical Center

Peoria, Illinois, United States

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Illinois CancerCare - Peru

Peru, Illinois, United States

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Illinois Valley Community Hospital

Peru, Illinois, United States

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Illinois CancerCare - Princeton

Princeton, Illinois, United States

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Illinois CancerCare - Spring Valley

Spring Valley, Illinois, United States

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CCOP - Carle Cancer Center

Urbana, Illinois, United States

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Elkhart Clinic, LLC

Elkhart, Indiana, United States

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Michiana Hematology-Oncology, PC - Elkhart

Elkhart, Indiana, United States

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Elkhart General Hospital

Elkhart, Indiana, United States

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St. Francis Hospital Cancer Care Services

Indianapolis, Indiana, United States

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Howard Community Hospital

Kokomo, Indiana, United States

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Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, United States

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Saint Anthony Memorial Health Centers

Michigan City, Indiana, United States

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Michiana Hematology-Oncology, PC - South Bend

Mishawaka, Indiana, United States

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Saint Joseph Regional Medical Center

Mishawaka, Indiana, United States

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Michiana Hematology Oncology PC - Plymouth

Plymouth, Indiana, United States

Site Status

Reid Hospital & Health Care Services

Richmond, Indiana, United States

Site Status

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, United States

Site Status

Memorial Hospital of South Bend

South Bend, Indiana, United States

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Michiana Hematology Oncology PC - La Porte

Westville, Indiana, United States

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McFarland Clinic, PC

Ames, Iowa, United States

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Bettendorf, Iowa, United States

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Cedar Rapids Oncology Associates

Cedar Rapids, Iowa, United States

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Mercy Regional Cancer Center at Mercy Medical Center

Cedar Rapids, 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

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CCOP - Iowa Oncology Research Association

Des Moines, Iowa, United States

Site Status

John Stoddard Cancer Center at Iowa Methodist Medical Center

Des Moines, Iowa, United States

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Medical Oncology and Hematology Associates at John Stoddard Cancer Center

Des Moines, Iowa, United States

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Medical Oncology and Hematology Associates at Mercy Cancer Center

Des Moines, Iowa, United States

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Mercy Cancer Center at Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

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John Stoddard Cancer Center at Iowa Lutheran Hospital

Des Moines, Iowa, United States

Site Status

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, United States

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Mercy Cancer Center at Mercy Medical Center - North Iowa

Mason City, Iowa, United States

Site Status

McCreery Cancer Center at Ottumwa Regional

Ottumwa, Iowa, United States

Site Status

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, United States

Site Status

Mercy Medical Center - Sioux City

Sioux City, Iowa, United States

Site Status

St. Luke's Regional Medical Center

Sioux City, Iowa, United States

Site Status

Methodist West Hospital

West Des Moines, Iowa, United States

Site Status

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, United States

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Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, United States

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Cancer Center of Kansas, PA - 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

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Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, United States

Site Status

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Liberal

Liberal, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Newton

Newton, Kansas, United States

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Menorah Medical Center

Overland Park, Kansas, United States

Site Status

Saint Luke's Hospital - South

Overland Park, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, United States

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CCOP - Kansas City

Prairie Village, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, United States

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Cancer Center of Kansas, PA - Salina

Salina, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, United States

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Associates in Womens Health, PA - North Review

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, United States

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Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, United States

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CCOP - Wichita

Wichita, Kansas, United States

Site Status

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, United States

Site Status

Boston University Cancer Research Center

Boston, Massachusetts, United States

Site Status

Hickman Cancer Center at Bixby Medical Center

Adrian, Michigan, United States

Site Status

Saint Joseph Mercy Cancer Center

Ann Arbor, Michigan, United States

Site Status

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, United States

Site Status

Battle Creek Health System Cancer Care Center

Battle Creek, Michigan, United States

Site Status

Mecosta County Medical Center

Big Rapids, Michigan, United States

Site Status

Oakwood Cancer Center at Oakwood Hospital and Medical Center

Dearborn, Michigan, United States

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Green Bay Oncology, Limited - Escanaba

Escanaba, Michigan, United States

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Genesys Hurley Cancer Institute

Flint, Michigan, United States

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Hurley Medical Center

Flint, Michigan, United States

Site Status

Butterworth Hospital at Spectrum Health

Grand Rapids, Michigan, United States

Site Status

CCOP - Grand Rapids

Grand Rapids, Michigan, United States

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Lacks Cancer Center at Saint Mary's Health Care

Grand Rapids, Michigan, United States

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Van Elslander Cancer Center at St. John Hospital and Medical Center

Grosse Pointe Woods, Michigan, United States

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Dickinson County Healthcare System

Iron Mountain, Michigan, United States

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Foote Memorial Hospital

Jackson, Michigan, United States

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Sparrow Regional Cancer Center

Lansing, Michigan, United States

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St. Mary Mercy Hospital

Livonia, Michigan, United States

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Community Cancer Center of Monroe

Monroe, Michigan, United States

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Mercy Memorial Hospital - Monroe

Monroe, Michigan, United States

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Mercy General Health Partners

Muskegon, Michigan, United States

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St. Joseph Mercy Oakland

Pontiac, Michigan, United States

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Mercy Regional Cancer Center at Mercy Hospital

Port Huron, Michigan, United States

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Spectrum Health Reed City Hospital

Reed City, Michigan, United States

Site Status

Seton Cancer Institute at Saint Mary's - Saginaw

Saginaw, Michigan, United States

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Lakeland Regional Cancer Care Center - St. Joseph

Saint Joseph, Michigan, United States

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Lakeside Cancer Specialists, PLLC

Saint Joseph, Michigan, United States

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Munson Medical Center

Traverse City, Michigan, United States

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St. John Macomb Hospital

Warren, Michigan, United States

Site Status

MeritCare Bemidji

Bemidji, Minnesota, United States

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St. Joseph's Medical Center

Brainerd, Minnesota, United States

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Fairview Ridges Hospital

Burnsville, Minnesota, United States

Site Status

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, United States

Site Status

Essentia Health - Duluth Clinic

Duluth, Minnesota, United States

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CCOP - Duluth

Duluth, Minnesota, United States

Site Status

Miller - Dwan Medical Center

Duluth, Minnesota, United States

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Fairview Southdale Hospital

Edina, Minnesota, United States

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Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, United States

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Hutchinson Area Health Care

Hutchinson, Minnesota, United States

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HealthEast Cancer Care at St. John's Hospital

Maplewood, Minnesota, United States

Site Status

Minnesota Oncology - Maplewood

Maplewood, Minnesota, United States

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Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

Minneapolis, Minnesota, United States

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Hennepin County Medical Center - Minneapolis

Minneapolis, Minnesota, United States

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Humphrey Cancer Center at North Memorial Outpatient Center

Robbinsdale, Minnesota, United States

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Mayo Clinic Cancer Center

Rochester, Minnesota, United States

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CentraCare Clinic - River Campus

Saint Cloud, Minnesota, United States

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Coborn Cancer Center

Saint Cloud, Minnesota, United States

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CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, United States

Site Status

Park Nicollet Cancer Center

Saint Louis Park, Minnesota, United States

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Regions Hospital Cancer Care Center

Saint Paul, Minnesota, United States

Site Status

United Hospital

Saint Paul, Minnesota, United States

Site Status

St. Francis Cancer Center at St. Francis Medical Center

Shakopee, Minnesota, United States

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Lakeview Hospital

Stillwater, Minnesota, United States

Site Status

Ridgeview Medical Center

Waconia, Minnesota, United States

Site Status

Willmar Cancer Center at Rice Memorial Hospital

Willmar, Minnesota, United States

Site Status

Minnesota Oncology - Woodbury

Woodbury, Minnesota, United States

Site Status

Southeast Cancer Center

Cape Girardeau, Missouri, United States

Site Status

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, United States

Site Status

Goldschmidt Cancer Center

Jefferson City, Missouri, United States

Site Status

Saint Luke's Cancer Institute at Saint Luke's Hospital

Kansas City, Missouri, United States

Site Status

North Kansas City Hospital

Kansas City, Missouri, United States

Site Status

Heartland Hematology 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

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Mercy Clinic Cancer and Hematology - Rolla

Rolla, Missouri, United States

Site Status

Saint Joseph Oncology, Incorporated

Saint Joseph, Missouri, United States

Site Status

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, United States

Site Status

St. John's Regional Health Center

Springfield, Missouri, United States

Site Status

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, United States

Site Status

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, United States

Site Status

Missouri Baptist Cancer Center

St Louis, Missouri, United States

Site Status

CCOP - Montana Cancer Consortium

Billings, Montana, United States

Site Status

St. Vincent Healthcare Cancer Care Services

Billings, Montana, United States

Site Status

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, United States

Site Status

Billings Clinic - Downtown

Billings, Montana, United States

Site Status

Bozeman Deaconess Cancer Center

Bozeman, Montana, United States

Site Status

St. James Healthcare Cancer Care

Butte, Montana, United States

Site Status

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Site Status

St. Peter's Hospital

Helena, Montana, United States

Site Status

Kalispell Regional Medical Center

Kalispell, Montana, United States

Site Status

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, United States

Site Status

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, United States

Site Status

Cancer Resource Center - Lincoln

Lincoln, Nebraska, United States

Site Status

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, United States

Site Status

Immanuel Medical Center

Omaha, Nebraska, United States

Site Status

Alegant Health Cancer Center at Bergan Mercy Medical Center

Omaha, Nebraska, United States

Site Status

Lakeside Hospital

Omaha, Nebraska, United States

Site Status

Creighton University Medical Center

Omaha, Nebraska, United States

Site Status

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

Site Status

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, United States

Site Status

Charles R. Wood Cancer Center at Glens Falls Hospital

Glens Falls, New York, United States

Site Status

Randolph Hospital

Asheboro, North Carolina, United States

Site Status

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, United States

Site Status

Moses Cone Regional Cancer Center at Wesley Long Community Hospital

Greensboro, North Carolina, United States

Site Status

Pardee Memorial Hospital

Hendersonville, North Carolina, United States

Site Status

Kinston Medical Specialists

Kinston, North Carolina, United States

Site Status

FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center

Pinehurst, North Carolina, United States

Site Status

Annie Penn Cancer Center

Reidsville, North Carolina, United States

Site Status

Iredell Memorial Hospital

Statesville, North Carolina, United States

Site Status

Medcenter One Hospital Cancer Care Center

Bismarck, North Dakota, United States

Site Status

Mid Dakota Clinic, PC

Bismarck, North Dakota, United States

Site Status

St. Alexius Medical Center Cancer Center

Bismarck, North Dakota, United States

Site Status

MeritCare Broadway

Fargo, North Dakota, United States

Site Status

Altru Cancer Center at Altru Hospital

Grand Forks, North Dakota, United States

Site Status

Wood County Oncology Center

Bowling Green, Ohio, United States

Site Status

Adena Regional Medical Center

Chillicothe, Ohio, United States

Site Status

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, United States

Site Status

CCOP - Columbus

Columbus, Ohio, United States

Site Status

Grant Medical Center Cancer Care

Columbus, Ohio, United States

Site Status

Mount Carmel Health - West Hospital

Columbus, Ohio, United States

Site Status

Doctors Hospital at Ohio Health

Columbus, Ohio, United States

Site Status

Grandview Hospital

Dayton, Ohio, United States

Site Status

Good Samaritan Hospital

Dayton, Ohio, United States

Site Status

David L. Rike Cancer Center at Miami Valley Hospital

Dayton, Ohio, United States

Site Status

Samaritan North Cancer Care Center

Dayton, Ohio, United States

Site Status

CCOP - Dayton

Dayton, Ohio, United States

Site Status

Grady Memorial Hospital

Delaware, Ohio, United States

Site Status

Community Cancer Center

Elyria, Ohio, United States

Site Status

Hematology Oncology Center

Elyria, Ohio, United States

Site Status

Blanchard Valley Medical Associates

Findlay, Ohio, United States

Site Status

Middletown Regional Hospital

Franklin, Ohio, United States

Site Status

Wayne Hospital

Greenville, Ohio, United States

Site Status

Charles F. Kettering Memorial Hospital

Kettering, Ohio, United States

Site Status

Fairfield Medical Center

Lancaster, Ohio, United States

Site Status

Lima Memorial Hospital

Lima, Ohio, United States

Site Status

Strecker Cancer Center at Marietta Memorial Hospital

Marietta, Ohio, United States

Site Status

Northwest Ohio Oncology Center

Maumee, Ohio, United States

Site Status

Knox Community Hospital

Mount Vernon, Ohio, United States

Site Status

Licking Memorial Cancer Care Program at Licking Memorial Hospital

Newark, Ohio, United States

Site Status

St. Charles Mercy Hospital

Oregon, Ohio, United States

Site Status

Toledo Clinic - Oregon

Oregon, Ohio, United States

Site Status

Southern Ohio Medical Center Cancer Center

Portsmouth, Ohio, United States

Site Status

Community Hospital of Springfield and Clark County

Springfield, Ohio, United States

Site Status

Flower Hospital Cancer Center

Sylvania, Ohio, United States

Site Status

Mercy Hospital of Tiffin

Tiffin, Ohio, United States

Site Status

Toledo Hospital

Toledo, Ohio, United States

Site Status

St. Vincent Mercy Medical Center

Toledo, Ohio, United States

Site Status

Medical University of Ohio Cancer Center

Toledo, Ohio, United States

Site Status

St. Anne Mercy Hospital

Toledo, Ohio, United States

Site Status

Toledo Clinic, Incorporated - Main Clinic

Toledo, Ohio, United States

Site Status

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, United States

Site Status

Fulton County Health Center

Wauseon, Ohio, United States

Site Status

Mount Carmel St. Ann's Cancer Center

Westerville, Ohio, United States

Site Status

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

Xenia, Ohio, United States

Site Status

Genesis - Good Samaritan Hospital

Zanesville, Ohio, United States

Site Status

Cancer Care Associates - Norman

Norman, Oklahoma, United States

Site Status

Cancer Care Associates - Mercy Campus

Oklahoma City, Oklahoma, United States

Site Status

Natalie Warren Bryant Cancer Center at St. Francis Hospital

Tulsa, Oklahoma, United States

Site Status

Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

Allentown, Pennsylvania, United States

Site Status

Geisinger Cancer Institute at Geisinger Health

Danville, Pennsylvania, United States

Site Status

Geisinger Hazleton Cancer Center

Hazleton, Pennsylvania, United States

Site Status

Guthrie Cancer Center at Guthrie Clinic Sayre

Sayre, Pennsylvania, United States

Site Status

Geisinger Medical Group - Scenery Park

State College, Pennsylvania, United States

Site Status

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, United States

Site Status

Cancer Centers of the Carolinas - Faris Road

Greenville, South Carolina, United States

Site Status

Cancer Centers of the Carolinas - Grove Commons

Greenville, South Carolina, United States

Site Status

Greenville Hospital Cancer Center

Greenville, South Carolina, United States

Site Status

CCOP - Greenville

Greenville, South Carolina, United States

Site Status

Cancer Centers of the Carolinas - Greer Medical Oncology

Greer, South Carolina, United States

Site Status

Cancer Centers of the Carolinas - Seneca

Seneca, South Carolina, United States

Site Status

Cancer Centers of the Carolinas - Spartanburg

Spartanburg, South Carolina, United States

Site Status

Rapid City Regional Hospital

Rapid City, South Dakota, United States

Site Status

Sanford Cancer Center at Sanford USD Medical Center

Sioux Falls, South Dakota, United States

Site Status

Danville Regional Medical Center

Danville, Virginia, United States

Site Status

Fredericksburg Oncology, Incorporated

Fredericksburg, Virginia, United States

Site Status

Mary Babb Randolph Cancer Center at West Virginia University Hospitals

Morgantown, West Virginia, United States

Site Status

Center for Cancer Treatment & Prevention at Sacred Heart Hospital

Eau Claire, Wisconsin, United States

Site Status

Marshfield Clinic Cancer Care at Regional Cancer Center

Eau Claire, Wisconsin, United States

Site Status

Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, United States

Site Status

Green Bay Oncology, Limited at St. Mary's Hospital

Green Bay, Wisconsin, United States

Site Status

St. Mary's Hospital Medical Center - Green Bay

Green Bay, Wisconsin, United States

Site Status

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, United States

Site Status

Gundersen Lutheran Center for Cancer and Blood

La Crosse, Wisconsin, United States

Site Status

Holy Family Memorial Medical Center Cancer Care Center

Manitowoc, Wisconsin, United States

Site Status

Bay Area Cancer Care Center at Bay Area Medical Center

Marinette, Wisconsin, United States

Site Status

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, United States

Site Status

Saint Joseph's Hospital

Marshfield, Wisconsin, United States

Site Status

Marshfield Clinic - Lakeland Center

Minocqua, Wisconsin, United States

Site Status

Green Bay Oncology, Limited - Oconto Falls

Oconto Falls, Wisconsin, United States

Site Status

Ministry Medical Group at Saint Mary's Hospital

Rhinelander, Wisconsin, United States

Site Status

Marshfield Clinic - Indianhead Center

Rice Lake, Wisconsin, United States

Site Status

St. Nicholas Hospital

Sheboygan, Wisconsin, United States

Site Status

Marshfield Clinic at Saint Michael's Hospital

Stevens Point, Wisconsin, United States

Site Status

Saint Michael's Hospital Cancer Center

Stevens Point, Wisconsin, United States

Site Status

Green Bay Oncology, Limited - Sturgeon Bay

Sturgeon Bay, Wisconsin, United States

Site Status

Marshfield Clinic - Weston Center

Weston, Wisconsin, United States

Site Status

Marshfield Clinic - Wisconsin Rapids Center

Wisconsin Rapids, Wisconsin, United States

Site Status

Countries

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United States

References

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Slostad JA, Liu MC, Allred JB, Erickson LA, Rumilla KM, Block MS, Keppen M, King D, Markovic SN, McWilliams RR. BRAF V600 Mutation Detection in Plasma Cell-Free DNA: NCCTG N0879 (Alliance). Mayo Clin Proc Innov Qual Outcomes. 2021 Oct 13;5(6):1012-1020. doi: 10.1016/j.mayocpiqo.2021.05.003. eCollection 2021 Dec.

Reference Type DERIVED
PMID: 34703985 (View on PubMed)

Other Identifiers

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NCI-2011-01968

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000654465

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCCTG-N0879

Identifier Type: -

Identifier Source: org_study_id

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