Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery

NCT ID: NCT03180268

Last Updated: 2025-11-10

Study Results

Results pending

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

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-12

Study Completion Date

2027-06-15

Brief Summary

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This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.

Detailed Description

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PRIMARY OBJECTIVE:

I. To determine the extent of clinical benefit of the addition of adjuvant radiotherapy (RT) to gross total resection (GTR) for patients with newly diagnosed World Health Organization (WHO) grade II meningioma.

SECONDARY OBJECTIVES:

I. Overall survival (OS). II. Disease-specific survival (DSS). III. Toxicity (grade 3+, exclusive of expected alopecia). IV. Neurocognitive function (NCF). V. Patient reported outcomes (PRO) measurements. VI. Adherence to protocol-specific target and normal tissue parameters. VII. Concordance measurements of central versus parent-institution pathology. VIII. Assessment of pHH3 mitotic index and its correlation with progression-free survival (PFS) and OS.

IX. Validation of the prognostic value of a 34-gene expression biomarker. X. Validation of the predictive value of a 34-gene expression biomarker in predicting the benefit of radiotherapy.

XI. Tissue and specimen collection for future translational research.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo observation. Additionally, patients undergo magnetic resonance imaging (MRI) and blood collection throughout the study.

ARM II: Patients undergo intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy 5 days a week over 6.5-7 weeks for a total of 33 fractions in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and blood collection throughout the study.

After completion of study treatment, patients are followed up at 3, 6, and 12 months, every 6 months for year 2 and 3, then yearly for 10 years.

Conditions

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Grade 2 Meningioma Intracranial Meningioma

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 (observation)

Patients undergo observation. Additionally, patients undergo MRI and blood collection throughout the study.

Group Type ACTIVE_COMPARATOR

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood samples

Clinical Observation

Intervention Type OTHER

Undergo observation

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Arm II (radiation therapy)

Patients undergo IMRT or proton beam radiation therapy 5 days a week over 6.5-7 weeks for a total of 33 fractions in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and blood collection throughout the study.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood samples

Intensity-Modulated Radiation Therapy

Intervention Type RADIATION

Undergo IMRT

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Proton Beam Radiation Therapy

Intervention Type RADIATION

Undergo proton beam radiation therapy

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Interventions

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Biospecimen Collection

Undergo collection of blood samples

Intervention Type PROCEDURE

Clinical Observation

Undergo observation

Intervention Type OTHER

Intensity-Modulated Radiation Therapy

Undergo IMRT

Intervention Type RADIATION

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Magnetic Resonance Imaging

Undergo MRI

Intervention Type PROCEDURE

Proton Beam Radiation Therapy

Undergo proton beam radiation therapy

Intervention Type RADIATION

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection observation IMRT Intensity modulated radiation therapy (procedure) Intensity Modulated RT Intensity-Modulated Radiotherapy Radiation, Intensity-Modulated Radiotherapy Magnetic Resonance Magnetic Resonance Imaging (MRI) Magnetic resonance imaging (procedure) Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan MRIs NMR Imaging NMRI Nuclear Magnetic Resonance Imaging sMRI Structural MRI External beam radiation therapy protons (procedure) External Beam Radiotherapy (protons) PBRT Proton Proton EBRT Proton External Beam Radiotherapy Proton Radiation Therapy PROTON Therapy Radiation, Proton Beam Quality of Life Assessment

Eligibility Criteria

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Inclusion Criteria

* PRIOR TO STEP 1 REGISTRATION:
* The patient must have a newly diagnosed unifocal intracranial meningioma, gross totally resected, and histologically confirmed as WHO grade II based upon pathology findings at the enrolling institution. WHO grade will be assigned according to WHO 2016 criteria
* Gross total resection (GTR) will be interpreted as modified Simpson grade 1-3 without gross residual dural-based or extradural tumor. GTR must be confirmed both by modified Simpson grade and by post-operative magnetic resonance imaging (MRI) findings. The modified Simpson grade can be inferred from the operative report (surgeon does not need to explicitly describe the Simpson grade for the purposes of eligibility)
* Step 1 registration must occur within 180 days of the initial surgery; this will provide sufficient time for post-operative imaging confirmation of resection extent after resolution of operative changes. Moreover, it will permit additional surgery if needed to achieve a GTR. Within this 180 day interval, a second surgery is permitted in order to achieve GTR, but even with a second surgery, Step 1 registration must occur within 180 days of the initial resection
* GTR must be confirmed on post-operative imaging following the most recent surgery. For protocol enrollment, the assessment of GTR will be made at each site. However, submission of both pre-operative and post-operative MRIs is required for patients. If a second surgery is performed, submission of post-operative MRI is required and pre-operative MRI is required only if obtained. All sequences obtained in the pre- and post-operative MR imaging are to be submitted to National Radiology Group (NRG) Oncology for study registration. The post-operative MRI must be completed within sufficient time to permit step 1 registration within 180 days of the initial resection. These same conditions apply in the setting of a second surgical procedure, although if a second surgery is completed, step 1 registration must still occur with 180 days of initial surgery. Computed tomography (CT) imaging is not required, but may be obtained if desired clinically, for instance to assess calcifications or hyperostosis
* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
* NOTE: Central pathology review must occur between steps 1 and 2 of registration. Once appropriate pathology specimens are received, central pathology review will occur within 10 business days, and must confirm WHO grade II meningioma before the patient can proceed to step 2 registration and randomization
* PRIOR TO STEP 2 REGISTRATION:
* Histologically confirmed diagnosis of WHO grade II meningioma confirmed by central pathology review prior to step 2 registration
* Age \>= 18
* History/physical examination, including neurologic examination within 60 days prior to step 2 registration
* Post-operative Zubrod performance status 0-1 within 60 days prior to step 2 registration
* If the patient is a woman is of childbearing potential, a serum pregnancy test, obtained within 14 days prior to step 2 registration, must be negative, and, if randomized to receive radiation therapy, the woman must agree to use contraception

Exclusion Criteria

* Optic nerve sheath meningioma, spinal or other extracranial meningioma, multiple meningiomas, hemangiopericytoma
* Definitive evidence of metastatic meningioma (metastasis, although rare, can occur and is exclusionary)
* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (carcinoma in situ of the breast, oral cavity, cervix, melanoma in situ, or other non-invasive malignancies are permissible)
* Previous radiotherapy to the scalp, cranium, brain, or skull base and radiation-induced meningiomas
* Major medical illnesses or psychiatric impairments, which in the investigators opinion, will prevent administration or completion of the protocol therapy and/or preclude informed consent; these include, but are not restricted to:

* Unstable angina and/or congestive heart failure requiring hospitalization at the time of step 2 registration
* Transmural myocardial infarction within the last 6 months prior to step 2 registration
* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 2 registration
* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 2 registration
* Type II neurofibromatosis (NF2)
* Ailments entailing substantial increases in sensitivity and side effect risk from radiation therapy (ataxia telangiectasia, Nijmegen breakage syndrome, and human immunodeficiency virus (HIV) with CD4 count \< 200 cells/microliter); HIV testing is not required for eligibility for this protocol, and known HIV positive patients are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count \>= 200 cells/microliter within 30 days prior to step 2 registration
* Inability to undergo MRI with and without contrast (e.g. claustrophobia, non-MRI compatible implant or foreign body, gadolinium allergy or renal dysfunction preventing the patient from receiving gadolinium- institutional guidelines should be used to determine if patients are at risk for renal dysfunction). Note that patients with severe claustrophobia are permitted on this study if they are willing and able to undergo MRI with adequate sedation or anesthesia
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

NRG Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael A Vogelbaum

Role: PRINCIPAL_INVESTIGATOR

NRG Oncology

Locations

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University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Site Status ACTIVE_NOT_RECRUITING

Saint Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Site Status RECRUITING

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States

Site Status ACTIVE_NOT_RECRUITING

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status ACTIVE_NOT_RECRUITING

University of Arizona Cancer Center-Orange Grove Campus

Tucson, Arizona, United States

Site Status SUSPENDED

Banner University Medical Center - Tucson

Tucson, Arizona, United States

Site Status SUSPENDED

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

Site Status SUSPENDED

Kaiser Permanente-Anaheim

Anaheim, California, United States

Site Status RECRUITING

Sutter Cancer Centers Radiation Oncology Services-Auburn

Auburn, California, United States

Site Status RECRUITING

Kaiser Permanente-Bellflower

Bellflower, California, United States

Site Status RECRUITING

Kaiser Permanente Dublin

Dublin, California, United States

Site Status RECRUITING

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Los Angeles General Medical Center

Los Angeles, California, United States

Site Status RECRUITING

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status RECRUITING

Memorial Medical Center

Modesto, California, United States

Site Status RECRUITING

Kaiser Permanente Oakland-Broadway

Oakland, California, United States

Site Status RECRUITING

Kaiser Permanente-Ontario

Ontario, California, United States

Site Status RECRUITING

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Site Status ACTIVE_NOT_RECRUITING

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Site Status ACTIVE_NOT_RECRUITING

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, United States

Site Status RECRUITING

Rohnert Park Cancer Center

Rohnert Park, California, United States

Site Status RECRUITING

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, United States

Site Status RECRUITING

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, United States

Site Status RECRUITING

Sutter Medical Center Sacramento

Sacramento, California, United States

Site Status RECRUITING

South Sacramento Cancer Center

Sacramento, California, United States

Site Status RECRUITING

California Pacific Medical Center-Pacific Campus

San Francisco, California, United States

Site Status RECRUITING

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Site Status RECRUITING

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, United States

Site Status RECRUITING

Sutter Solano Medical Center/Cancer Center

Vallejo, California, United States

Site Status RECRUITING

Hartford Hospital

Hartford, Connecticut, United States

Site Status RECRUITING

Yale University

New Haven, Connecticut, United States

Site Status ACTIVE_NOT_RECRUITING

Helen F Graham Cancer Center

Newark, Delaware, United States

Site Status ACTIVE_NOT_RECRUITING

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Site Status ACTIVE_NOT_RECRUITING

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Site Status ACTIVE_NOT_RECRUITING

TidalHealth Nanticoke / Allen Cancer Center

Seaford, Delaware, United States

Site Status ACTIVE_NOT_RECRUITING

Boca Raton Regional Hospital

Boca Raton, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

Site Status RECRUITING

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

Site Status RECRUITING

UM Sylvester Comprehensive Cancer Center at Doral

Doral, Florida, United States

Site Status RECRUITING

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, United States

Site Status RECRUITING

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Site Status RECRUITING

Miami Cancer Institute

Miami, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

AdventHealth Orlando

Orlando, Florida, United States

Site Status RECRUITING

AdventHealth East Orlando

Orlando, Florida, United States

Site Status RECRUITING

Memorial Hospital West

Pembroke Pines, Florida, United States

Site Status RECRUITING

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center

Tampa, Florida, United States

Site Status SUSPENDED

Grady Health System

Atlanta, Georgia, United States

Site Status RECRUITING

Emory Proton Therapy Center

Atlanta, Georgia, United States

Site Status RECRUITING

Piedmont Hospital

Atlanta, Georgia, United States

Site Status RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Site Status RECRUITING

Northside Hospital

Atlanta, Georgia, United States

Site Status ACTIVE_NOT_RECRUITING

Northside Hospital-Forsyth

Cumming, Georgia, United States

Site Status ACTIVE_NOT_RECRUITING

Piedmont Fayette Hospital

Fayetteville, Georgia, United States

Site Status RECRUITING

Piedmont Newnan Hospital

Newnan, Georgia, United States

Site Status RECRUITING

Piedmont Henry Hospital

Stockbridge, Georgia, United States

Site Status RECRUITING

Queen's Medical Center

Honolulu, Hawaii, United States

Site Status RECRUITING

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, United States

Site Status RECRUITING

Northwestern University

Chicago, Illinois, United States

Site Status RECRUITING

Rush MD Anderson Cancer Center

Chicago, Illinois, United States

Site Status RECRUITING

University of Illinois

Chicago, Illinois, United States

Site Status RECRUITING

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status ACTIVE_NOT_RECRUITING

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

Site Status RECRUITING

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

Site Status RECRUITING

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, United States

Site Status RECRUITING

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, United States

Site Status RECRUITING

Loyola University Medical Center

Maywood, Illinois, United States

Site Status RECRUITING

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

Site Status RECRUITING

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Site Status ACTIVE_NOT_RECRUITING

IU Health Methodist Hospital

Indianapolis, Indiana, United States

Site Status ACTIVE_NOT_RECRUITING

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Site Status RECRUITING

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Site Status ACTIVE_NOT_RECRUITING

University of Kansas Cancer Center

Kansas City, Kansas, United States

Site Status ACTIVE_NOT_RECRUITING

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, United States

Site Status ACTIVE_NOT_RECRUITING

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Site Status ACTIVE_NOT_RECRUITING

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, United States

Site Status RECRUITING

UofL Health Medical Center Northeast

Louisville, Kentucky, United States

Site Status RECRUITING

LSU Health Sciences Center at Shreveport

Shreveport, Louisiana, United States

Site Status ACTIVE_NOT_RECRUITING

MaineHealth Coastal Cancer Treatment Center

Bath, Maine, United States

Site Status RECRUITING

MaineHealth Maine Medical Center - Portland

Portland, Maine, United States

Site Status RECRUITING

MaineHealth Cancer Care Center of York County

Sanford, Maine, United States

Site Status RECRUITING

MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, United States

Site Status RECRUITING

Maryland Proton Treatment Center

Baltimore, Maryland, United States

Site Status ACTIVE_NOT_RECRUITING

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

Site Status ACTIVE_NOT_RECRUITING

Tufts Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

Site Status SUSPENDED

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status ACTIVE_NOT_RECRUITING

Chelsea Hospital

Chelsea, Michigan, United States

Site Status SUSPENDED

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, United States

Site Status RECRUITING

Henry Ford Hospital

Detroit, Michigan, United States

Site Status RECRUITING

Henry Ford Health Saint John Hospital

Detroit, Michigan, United States

Site Status SUSPENDED

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Site Status SUSPENDED

MyMichigan Medical Center Saginaw

Saginaw, Michigan, United States

Site Status RECRUITING

Henry Ford Health Warren Hospital

Warren, Michigan, United States

Site Status SUSPENDED

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States

Site Status RECRUITING

University of Michigan Health - West

Wyoming, Michigan, United States

Site Status RECRUITING

Essentia Health Cancer Center

Duluth, Minnesota, United States

Site Status RECRUITING

Miller-Dwan Hospital

Duluth, Minnesota, United States

Site Status RECRUITING

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Site Status RECRUITING

Regions Hospital

Saint Paul, Minnesota, United States

Site Status RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status ACTIVE_NOT_RECRUITING

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Site Status RECRUITING

MU Health - University Hospital/Ellis Fischel Cancer Center

Columbia, Missouri, United States

Site Status ACTIVE_NOT_RECRUITING

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Site Status RECRUITING

Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Siteman Cancer Center-South County

St Louis, Missouri, United States

Site Status RECRUITING

Billings Clinic Cancer Center

Billings, Montana, United States

Site Status SUSPENDED

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Site Status RECRUITING

Logan Health Medical Center

Kalispell, Montana, United States

Site Status SUSPENDED

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status ACTIVE_NOT_RECRUITING

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States

Site Status RECRUITING

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Site Status ACTIVE_NOT_RECRUITING

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Site Status ACTIVE_NOT_RECRUITING

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Site Status ACTIVE_NOT_RECRUITING

Jersey Shore Medical Center

Neptune City, New Jersey, United States

Site Status RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status RECRUITING

Rutgers New Jersey Medical School

Newark, New Jersey, United States

Site Status SUSPENDED

Capital Health Medical Center-Hopewell

Pennington, New Jersey, United States

Site Status RECRUITING

ProCure Proton Therapy Center-Somerset

Somerset, New Jersey, United States

Site Status ACTIVE_NOT_RECRUITING

Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, United States

Site Status ACTIVE_NOT_RECRUITING

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Site Status RECRUITING

New York-Presbyterian/Brooklyn Methodist Hospital

Brooklyn, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Commack

Commack, New York, United States

Site Status ACTIVE_NOT_RECRUITING

The New York Hospital Medical Center of Queens

Flushing, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Site Status ACTIVE_NOT_RECRUITING

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status ACTIVE_NOT_RECRUITING

NYP/Weill Cornell Medical Center

New York, New York, United States

Site Status RECRUITING

University of Rochester

Rochester, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Westchester Medical Center

Valhalla, New York, United States

Site Status RECRUITING

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

Case Western Reserve University

Cleveland, Ohio, United States

Site Status RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status RECRUITING

Mercy Cancer Center-Elyria

Elyria, Ohio, United States

Site Status SUSPENDED

Kettering Medical Center

Kettering, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, United States

Site Status RECRUITING

ProMedica Flower Hospital

Sylvania, Ohio, United States

Site Status RECRUITING

UHHS-Westlake Medical Center

Westlake, Ohio, United States

Site Status RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Legacy Mount Hood Medical Center

Gresham, Oregon, United States

Site Status ACTIVE_NOT_RECRUITING

Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, United States

Site Status ACTIVE_NOT_RECRUITING

Saint Luke's University Hospital-Bethlehem Campus

Bethlehem, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status RECRUITING

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, United States

Site Status RECRUITING

Lewistown Hospital

Lewistown, Pennsylvania, United States

Site Status RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

Temple University Hospital

Philadelphia, Pennsylvania, United States

Site Status SUSPENDED

Geisinger Cancer Services-Pottsville

Pottsville, Pennsylvania, United States

Site Status RECRUITING

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

Site Status RECRUITING

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Site Status SUSPENDED

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

Prisma Health Cancer Institute - Greer

Greer, South Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Site Status ACTIVE_NOT_RECRUITING

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Site Status RECRUITING

M D Anderson Cancer Center

Houston, Texas, United States

Site Status WITHDRAWN

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

American Fork Hospital / Huntsman Intermountain Cancer Center

American Fork, Utah, United States

Site Status RECRUITING

Logan Regional Hospital

Logan, Utah, United States

Site Status RECRUITING

Intermountain Medical Center

Murray, Utah, United States

Site Status RECRUITING

McKay-Dee Hospital Center

Ogden, Utah, United States

Site Status RECRUITING

Utah Valley Regional Medical Center

Provo, Utah, United States

Site Status RECRUITING

Riverton Hospital

Riverton, Utah, United States

Site Status RECRUITING

LDS Hospital

Salt Lake City, Utah, United States

Site Status RECRUITING

Dartmouth Cancer Center - North

Saint Johnsbury, Vermont, United States

Site Status RECRUITING

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

Site Status ACTIVE_NOT_RECRUITING

University of Washington Medical Center - Montlake

Seattle, Washington, United States

Site Status ACTIVE_NOT_RECRUITING

Legacy Salmon Creek Hospital

Vancouver, Washington, United States

Site Status ACTIVE_NOT_RECRUITING

Langlade Hospital and Cancer Center

Antigo, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, United States

Site Status RECRUITING

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, United States

Site Status RECRUITING

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Site Status RECRUITING

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, United States

Site Status RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, United States

Site Status RECRUITING

Drexel Town Square Health Center

Oak Creek, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, United States

Site Status RECRUITING

Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, United States

Site Status RECRUITING

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, United States

Site Status RECRUITING

Aspirus Regional Cancer Center

Wausau, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center - Weston

Weston, Wisconsin, United States

Site Status RECRUITING

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, United States

Site Status RECRUITING

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Site Status SUSPENDED

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status ACTIVE_NOT_RECRUITING

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status SUSPENDED

London Regional Cancer Program

London, Ontario, Canada

Site Status SUSPENDED

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

CHUM - Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Site Status SUSPENDED

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

Montreal, Quebec, Canada

Site Status RECRUITING

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Site Status ACTIVE_NOT_RECRUITING

Tata Memorial Hospital

Mumbai, , India

Site Status SUSPENDED

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Site Status RECRUITING

Iwate Medical University Hospital

Shiwa-gun, Iwate, Japan

Site Status RECRUITING

Kyorin University Hospital

Mitaka-shi, Tokyo, Japan

Site Status RECRUITING

Keio University

Shinjuku-ku, Tokyo, Japan

Site Status RECRUITING

Hiroshima University Hospital

Hiroshima, , Japan

Site Status RECRUITING

Saitama Medical University International Medical Center

Saitama, , Japan

Site Status SUSPENDED

National Cancer Center Hospital

Tokyo, , Japan

Site Status RECRUITING

King Faisal Specialist Hospital and Research Centre

Riyadh, , Saudi Arabia

Site Status SUSPENDED

Countries

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

United States Canada India Japan Saudi Arabia

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

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Other Identifiers

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

NCI-2016-01619

Identifier Type: REGISTRY

Identifier Source: secondary_id

NRG-BN003

Identifier Type: -

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NRG-BN003

Identifier Type: OTHER

Identifier Source: secondary_id

NRG-BN003

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180868

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NRG-BN003

Identifier Type: -

Identifier Source: org_study_id