Corticosteroids + Bevacizumab vs. Corticosteroids + Placebo (BEST) for Radionecrosis After Radiosurgery for Brain Metastases

NCT ID: NCT02490878

Last Updated: 2023-03-23

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2022-12-15

Brief Summary

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This randomized phase II study aims to investigate whether the addition of bevacizumab to standard corticosteroid therapy results in greater improvement in symptoms and less treatment-induced symptoms compared with standard corticosteroid therapy for patients with symptomatic brain radionecrosis following radiosurgery. It is hypothesized that the addition of bevacizumab to standard care corticosteroids will reduce treatment-induced toxicities and improve neurologic impairments in patients with brain radionecrosis following radiosurgery for brain metastases.

Detailed Description

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This is a randomized double-blinded phase II study of corticosteroids with bevacizumab vs. corticosteroids with placebo for brain radionecrosis following radiosurgery for brain metastases. This is a two-arm clinical trial with parallel group design for longitudinal quality of life endpoint. Patients will be stratified according to age (≤ 65 years vs. \> 65 years), pathological confirmation of necrosis (yes vs. no), MDASI-BT mean global score (symptom + interference scores) ( \< 4.0 vs. \> 4.0) and prior whole brain radiotherapy (yes vs. no). The primary and secondary objectives are detailed below.

Primary Objective:

To investigate whether the addition of bevacizumab to standard corticosteroid therapy results in greater improvement in symptoms (clinical and patient-reported symptom improvement associated with radionecrosis and less radionecrosis treatment-induced symptoms) compared with standard corticosteroid therapy.

Secondary Objectives:

1. To evaluate the toxicity profile associated with bevacizumab and corticosteroid therapy.
2. To compare self-reported health related quality of life (HRQOL) using LASA, Dexamethasone Symptoms Questionnaire-Chronic (DSQ-C), and MDASI-BT symptom and interference score between treatment arms.
3. To compare intracranial progression-free survival and time to maximum radiographic response between treatment arms.
4. To compare the dose and duration of corticosteroids required between treatment arms and correlate steroid requirement with DSQ-C and MDASI-BT scores.

Patient event monitoring will occur every 2 months after treatment up to 6 months. Then event monitoring will occur up to one year.

Conditions

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Radionecrosis Brain Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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bevacizumab + corticosteroids

The patient will receive bevacizumab 10 mg/kg IV given on days 1 and 15 of a 28 day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.

Patients who meet the criteria for clinical progression will be treated as per treating MD.

Group Type EXPERIMENTAL

bevacizumab

Intervention Type DRUG

IV

corticosteroids

Intervention Type DRUG

IV

placebo + corticosteroids

The patient will receive placebo 0.9% NaCl volume equal to bevacizumab volume added to 100 mL bag of 0.9% NaCl delivered IV given on days 1 and 15 of a 28-day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.

Patients who meet the criteria for clinical progression will be allowed to receive bevacizumab according to the protocol.

Group Type EXPERIMENTAL

corticosteroids

Intervention Type DRUG

IV

placebo

Intervention Type OTHER

IV

Interventions

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bevacizumab

IV

Intervention Type DRUG

corticosteroids

IV

Intervention Type DRUG

placebo

IV

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

10.4 No current New York Heart Association classification II, III, or IV congestive heart failure.
11. No history of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within past 12 months.
12. No central lung metastases with excessive active bleeding.
13. No uncontrolled intercurrent illness including, but not limited to any of the following:

ongoing or active infection requiring IV antibiotics, cardiac arrhythmia, or psychiatric illness and/or social situations that would limit compliance with study requirements.
14. No history of serious non-healing wound, ulcer, or bone fractures.
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

Genentech, Inc.

INDUSTRY

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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Caroline Chung, MD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Locations

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Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States

Site Status

Anchorage Radiation Therapy Center

Anchorage, Alaska, United States

Site Status

Alaska Breast Care and Surgery LLC

Anchorage, Alaska, United States

Site Status

Alaska Oncology and Hematology LLC

Anchorage, Alaska, United States

Site Status

Alaska Women's Cancer Care

Anchorage, Alaska, United States

Site Status

Anchorage Oncology Centre

Anchorage, Alaska, United States

Site Status

Katmai Oncology Group

Anchorage, Alaska, United States

Site Status

Providence Alaska Medical Center

Anchorage, Alaska, United States

Site Status

PCR Oncology

Arroyo Grande, California, United States

Site Status

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Site Status

UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status

Beebe Medical Center

Lewes, Delaware, United States

Site Status

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, United States

Site Status

Helen F Graham Cancer Center

Newark, Delaware, United States

Site Status

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Site Status

Regional Hematology and Oncology PA

Newark, Delaware, United States

Site Status

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Site Status

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Site Status

Nanticoke Memorial Hospital

Seaford, Delaware, United States

Site Status

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, United States

Site Status

Boca Raton Regional Hospital

Boca Raton, Florida, United States

Site Status

Halifax Health Medical Center-Centers for Oncology

Daytona Beach, Florida, United States

Site Status

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

Site Status

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Moffitt Cancer Center

Tampa, Florida, United States

Site Status

University Cancer and Blood Center LLC

Athens, Georgia, United States

Site Status

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status

Memorial Health University Medical Center

Savannah, Georgia, United States

Site Status

Summit Cancer Care-Memorial

Savannah, Georgia, United States

Site Status

Low Country Cancer Care Associates PC

Savannah, Georgia, United States

Site Status

Summit Cancer Care-Candler

Savannah, Georgia, United States

Site Status

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Site Status

Saint Luke's Mountain States Tumor Institute

Boise, Idaho, United States

Site Status

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Site Status

Kootenai Medical Center

Coeur d'Alene, Idaho, United States

Site Status

Walter Knox Memorial Hospital

Emmett, Idaho, United States

Site Status

Saint Luke's Mountain States Tumor Institute - Fruitland

Fruitland, Idaho, United States

Site Status

Idaho Urologic Institute-Meridian

Meridian, Idaho, United States

Site Status

Saint Luke's Mountain States Tumor Institute - Meridian

Meridian, Idaho, United States

Site Status

Saint Alphonsus Medical Center-Nampa

Nampa, Idaho, United States

Site Status

Saint Luke's Mountain States Tumor Institute - Nampa

Nampa, Idaho, United States

Site Status

Kootenai Cancer Center

Post Falls, Idaho, United States

Site Status

Kootenai Cancer Clinic

Sandpoint, Idaho, United States

Site Status

Saint Luke's Mountain States Tumor Institute-Twin Falls

Twin Falls, Idaho, United States

Site Status

Rush - Copley Medical Center

Aurora, Illinois, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

University of Illinois

Chicago, Illinois, United States

Site Status

Carle on Vermilion

Danville, Illinois, United States

Site Status

Carle Physician Group-Effingham

Effingham, Illinois, United States

Site Status

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Site Status

Good Samaritan Regional Health Center

Mount Vernon, Illinois, United States

Site Status

Carle Cancer Center

Urbana, Illinois, United States

Site Status

The Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

Rush-Copley Healthcare Center

Yorkville, Illinois, United States

Site Status

Deaconess Clinic Downtown

Evansville, Indiana, United States

Site Status

Community Cancer Center East

Indianapolis, Indiana, United States

Site Status

Community Cancer Center South

Indianapolis, Indiana, United States

Site Status

Community Cancer Center North

Indianapolis, Indiana, United States

Site Status

Community Howard Regional Health

Kokomo, Indiana, United States

Site Status

Memorial Regional Cancer Center Day Road

Mishawaka, Indiana, United States

Site Status

Chancellor Center for Oncology

Newburgh, Indiana, United States

Site Status

Reid Health

Richmond, Indiana, United States

Site Status

Memorial Hospital of South Bend

South Bend, Indiana, United States

Site Status

Iowa Methodist Medical Center

Des Moines, Iowa, United States

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Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, United States

Site Status

Broadlawns Medical Center

Des Moines, Iowa, United States

Site Status

Iowa Lutheran Hospital

Des Moines, Iowa, United States

Site Status

Trinity Regional Medical Center

Fort Dodge, Iowa, United States

Site Status

Methodist West Hospital

West Des Moines, Iowa, United States

Site Status

Central Care Cancer Center - Garden City

Garden City, Kansas, United States

Site Status

Central Care Cancer Center - Great Bend

Great Bend, Kansas, United States

Site Status

Kansas Institute of Medicine Cancer and Blood Center

Lenexa, Kansas, United States

Site Status

Minimally Invasive Surgery Hospital

Lenexa, 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

Mercy Medical Center

Springfield, Massachusetts, United States

Site Status

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Site Status

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

IHA Hematology Oncology Consultants-Brighton

Brighton, Michigan, United States

Site Status

Saint Joseph Mercy Brighton

Brighton, Michigan, United States

Site Status

IHA Hematology Oncology Consultants-Canton

Canton, Michigan, United States

Site Status

Saint Joseph Mercy Canton

Canton, Michigan, United States

Site Status

Caro Cancer Center

Caro, Michigan, United States

Site Status

IHA Hematology Oncology Consultants-Chelsea

Chelsea, Michigan, United States

Site Status

Saint Joseph Mercy Chelsea

Chelsea, Michigan, United States

Site Status

Hematology Oncology Consultants-Clarkston

Clarkston, Michigan, United States

Site Status

Newland Medical Associates-Clarkston

Clarkston, Michigan, United States

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Beaumont Hospital-Dearborn

Dearborn, Michigan, United States

Site Status

Ascension Saint John Hospital

Detroit, Michigan, United States

Site Status

Great Lakes Cancer Management Specialists-Doctors Park

East China Township, Michigan, United States

Site Status

Beaumont Hospital - Farmington Hills

Farmington Hills, Michigan, United States

Site Status

Genesee Cancer and Blood Disease Treatment Center

Flint, Michigan, United States

Site Status

Genesee Hematology Oncology PC

Flint, Michigan, United States

Site Status

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Site Status

Hurley Medical Center

Flint, Michigan, United States

Site Status

William Beaumont Hospital-Grosse Point

Grosse Pointe, Michigan, United States

Site Status

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

Grosse Pointe Woods, Michigan, United States

Site Status

Lymphoma Clinic of Michigan

Grosse Pointe Woods, Michigan, United States

Site Status

Michigan Breast Specialists-Grosse Pointe Woods

Grosse Pointe Woods, Michigan, United States

Site Status

Allegiance Health

Jackson, Michigan, United States

Site Status

Sparrow Hospital

Lansing, Michigan, United States

Site Status

Hope Cancer Clinic

Livonia, Michigan, United States

Site Status

Saint Mary Mercy Hospital

Livonia, Michigan, United States

Site Status

Great Lakes Cancer Management Specialists-Macomb Medical Campus

Macomb, Michigan, United States

Site Status

Michigan Breast Specialists-Macomb Township

Macomb, Michigan, United States

Site Status

Saint Mary's Oncology/Hematology Associates of Marlette

Marlette, Michigan, United States

Site Status

Ascension Providence Hospitals - Novi

Novi, Michigan, United States

Site Status

21st Century Oncology-Pontiac

Pontiac, Michigan, United States

Site Status

Hope Cancer Center

Pontiac, Michigan, United States

Site Status

Newland Medical Associates-Pontiac

Pontiac, Michigan, United States

Site Status

Saint Joseph Mercy Oakland

Pontiac, Michigan, United States

Site Status

Huron Medical Center PC

Port Huron, Michigan, United States

Site Status

Lake Huron Medical Center

Port Huron, Michigan, United States

Site Status

Great Lakes Cancer Management Specialists-Rochester Hills

Rochester Hills, Michigan, United States

Site Status

Michigan Cancer Specialists

Roseville, Michigan, United States

Site Status

Oakland Colon and Rectal Association

Royal Oak, Michigan, United States

Site Status

Cancer Care Associates PC

Royal Oak, Michigan, United States

Site Status

Comprehensive Medical Center PLLC

Royal Oak, Michigan, United States

Site Status

Hematology Oncology Consultants PC

Royal Oak, Michigan, United States

Site Status

Oakland Medical Group

Royal Oak, Michigan, United States

Site Status

William Beaumont Hospital-Royal Oak

Royal Oak, Michigan, United States

Site Status

Saint Mary's of Michigan

Saginaw, Michigan, United States

Site Status

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, United States

Site Status

Ascension Providence Hospitals - Southfield

Southfield, Michigan, United States

Site Status

Bhadresh Nayak MD PC-Sterling Heights

Sterling Heights, Michigan, United States

Site Status

Premier Hematology Oncology Care

Sterling Heights, Michigan, United States

Site Status

Mitchell Folbe MD PC

Sterling Heights, Michigan, United States

Site Status

Saint Joseph Health System-Tawas City

Tawas City, Michigan, United States

Site Status

Michigan Institute of Urology-Town Center

Troy, Michigan, United States

Site Status

Claudia BR Herke MD PC

Troy, Michigan, United States

Site Status

William Beaumont Hospital - Troy

Troy, Michigan, United States

Site Status

Hematology Oncology Consultants PC-Troy

Troy, Michigan, United States

Site Status

Advanced Breast Care Center PLLC

Warren, Michigan, United States

Site Status

Bhadresh Nayak MD PC-Warren

Warren, Michigan, United States

Site Status

Great Lakes Cancer Management Specialists-Macomb Professional Building

Warren, Michigan, United States

Site Status

Macomb Hematology Oncology PC

Warren, Michigan, United States

Site Status

Michigan Breast Specialists-Warren

Warren, Michigan, United States

Site Status

Saint John Macomb-Oakland Hospital

Warren, Michigan, United States

Site Status

Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, United States

Site Status

Huron Gastroenterology PC

Ypsilanti, Michigan, United States

Site Status

IHA Hematology Oncology Consultants-Ann Arbor

Ypsilanti, Michigan, United States

Site Status

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, United States

Site Status

Essentia Health - Deer River Clinic

Deer River, Minnesota, United States

Site Status

Essentia Health Saint Mary's - Detroit Lakes Clinic

Detroit Lakes, 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

Lake Region Healthcare Corporation-Cancer Care

Fergus Falls, Minnesota, United States

Site Status

Essentia Health - Fosston

Fosston, Minnesota, United States

Site Status

Essentia Health Hibbing Clinic

Hibbing, Minnesota, United States

Site Status

Essentia Health - Park Rapids

Park Rapids, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Essentia Health Sandstone

Sandstone, Minnesota, United States

Site Status

Essentia Health Virginia Clinic

Virginia, Minnesota, United States

Site Status

Saint Louis Cancer and Breast Institute-Ballwin

Ballwin, Missouri, United States

Site Status

Central Care Cancer Center - Bolivar

Bolivar, Missouri, United States

Site Status

Cox Cancer Center Branson

Branson, Missouri, United States

Site Status

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Site Status

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Site Status

Centerpoint Medical Center LLC

Independence, Missouri, United States

Site Status

Freeman Health System

Joplin, Missouri, United States

Site Status

Mercy Hospital Joplin

Joplin, Missouri, United States

Site Status

Saint Luke's Hospital of Kansas City

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

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, United States

Site Status

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, United States

Site Status

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

Site Status

Mercy Hospital Springfield

Springfield, Missouri, United States

Site Status

CoxHealth South Hospital

Springfield, Missouri, United States

Site Status

Saint Louis Cancer and Breast Institute-South City

St Louis, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Mercy Hospital Washington

Washington, Missouri, United States

Site Status

Community Hospital of Anaconda

Anaconda, Montana, United States

Site Status

Billings Clinic Cancer Center

Billings, Montana, United States

Site Status

Bozeman Deaconess Hospital

Bozeman, 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

Saint Peter's Community Hospital

Helena, Montana, United States

Site Status

Kalispell Regional Medical Center

Kalispell, Montana, United States

Site Status

Community Medical Hospital

Missoula, Montana, United States

Site Status

Carson Tahoe Regional Medical Center

Carson City, Nevada, United States

Site Status

Cancer and Blood Specialists-Henderson

Henderson, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada-Horizon Ridge

Henderson, Nevada, United States

Site Status

Las Vegas Cancer Center-Henderson

Henderson, Nevada, United States

Site Status

Nevada Cancer Specialists-Saint Rose

Henderson, Nevada, United States

Site Status

21st Century Oncology-Henderson

Henderson, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada-Southeast Henderson

Henderson, Nevada, United States

Site Status

Desert West Surgery

Las Vegas, Nevada, United States

Site Status

Nevada Cancer Specialists?Oakey

Las Vegas, Nevada, United States

Site Status

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

Site Status

Cancer and Blood Specialists-Shadow

Las Vegas, Nevada, United States

Site Status

Radiation Oncology Centers of Nevada Central

Las Vegas, Nevada, United States

Site Status

21st Century Oncology

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-San Martin

Las Vegas, Nevada, United States

Site Status

Radiation Oncology Centers of Nevada Southeast

Las Vegas, Nevada, United States

Site Status

Cancer Therapy and Integrative Medicine

Las Vegas, Nevada, United States

Site Status

21st Century Oncology-Vegas Tenaya

Las Vegas, Nevada, United States

Site Status

Ann M Wierman MD LTD

Las Vegas, Nevada, United States

Site Status

Cancer and Blood Specialists-Tenaya

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada - Northwest

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-Tenaya

Las Vegas, Nevada, United States

Site Status

Nevada Cancer Specialists-Tenaya

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada-Summerlin

Las Vegas, Nevada, United States

Site Status

Summerlin Hospital Medical Center

Las Vegas, Nevada, United States

Site Status

Las Vegas Cancer Center-Medical Center

Las Vegas, Nevada, United States

Site Status

21st Century Oncology-Fort Apache

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Site Status

Nevada Cancer Specialists-Fort Apache

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada - Central Valley

Las Vegas, Nevada, United States

Site Status

University Cancer Center

Las Vegas, Nevada, United States

Site Status

Hope Cancer Care of Nevada-Pahrump

Pahrump, Nevada, United States

Site Status

Renown Regional Medical Center

Reno, Nevada, United States

Site Status

Saint Mary's Regional Medical Center

Reno, Nevada, United States

Site Status

Radiation Oncology Associates

Reno, Nevada, United States

Site Status

New Hampshire Oncology Hematology PA-Concord

Concord, New Hampshire, United States

Site Status

New Hampshire Oncology Hematology PA-Hooksett

Hooksett, New Hampshire, United States

Site Status

Englewood Hospital and Medical Center

Englewood, New Jersey, United States

Site Status

Overlook Hospital

Summit, New Jersey, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

Randolph Hospital

Asheboro, North Carolina, United States

Site Status

Cone Health Cancer Center at Alamance Regional

Burlington, North Carolina, United States

Site Status

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Site Status

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

Site Status

Southeastern Medical Oncology Center-Clinton

Clinton, North Carolina, United States

Site Status

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, United States

Site Status

Wayne Memorial Hospital

Goldsboro, North Carolina, United States

Site Status

Cone Health Cancer Center

Greensboro, North Carolina, United States

Site Status

East Carolina University

Greenville, North Carolina, United States

Site Status

Onslow Memorial Hospital

Jacksonville, North Carolina, United States

Site Status

Southeastern Medical Oncology Center-Jacksonville

Jacksonville, North Carolina, United States

Site Status

Cone Heath Cancer Center at Mebane

Mebane, North Carolina, United States

Site Status

Annie Penn Memorial Hospital

Reidsville, North Carolina, United States

Site Status

Southeastern Medical Oncology Center-Wilson

Wilson, North Carolina, United States

Site Status

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Essentia Health Cancer Center-South University Clinic

Fargo, North Dakota, United States

Site Status

Essentia Health - Jamestown Clinic

Jamestown, North Dakota, United States

Site Status

Cleveland Clinic Akron General

Akron, Ohio, United States

Site Status

Indu and Raj Soin Medical Center

Beavercreek, Ohio, United States

Site Status

Dayton Physicians LLC-Miami Valley South

Centerville, Ohio, United States

Site Status

Miami Valley Hospital South

Centerville, Ohio, United States

Site Status

Oncology Hematology Care Inc-Kenwood

Cincinnati, Ohio, United States

Site Status

Good Samaritan Hospital - Dayton

Dayton, Ohio, United States

Site Status

Miami Valley Hospital

Dayton, Ohio, United States

Site Status

Dayton Physicians LLC-Samaritan North

Dayton, Ohio, United States

Site Status

Miami Valley Hospital North

Dayton, Ohio, United States

Site Status

Armes Family Cancer Center

Findlay, Ohio, United States

Site Status

Blanchard Valley Hospital

Findlay, Ohio, United States

Site Status

Orion Cancer Care

Findlay, Ohio, United States

Site Status

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, United States

Site Status

Dayton Physicians LLC-Atrium

Franklin, Ohio, United States

Site Status

Dayton Physicians LLC-Wayne

Greenville, Ohio, United States

Site Status

Wayne Hospital

Greenville, Ohio, United States

Site Status

Greater Dayton Cancer Center

Kettering, Ohio, United States

Site Status

First Dayton Cancer Care

Kettering, Ohio, United States

Site Status

Kettering Medical Center

Kettering, Ohio, United States

Site Status

Dayton Physicians LLC-Signal Point

Middletown, Ohio, United States

Site Status

Dayton Physicians LLC-Wilson

Sidney, Ohio, United States

Site Status

Springfield Regional Cancer Center

Springfield, Ohio, United States

Site Status

Springfield Regional Medical Center

Springfield, Ohio, United States

Site Status

Dayton Physicians LLC-Upper Valley

Troy, Ohio, United States

Site Status

Upper Valley Medical Center

Troy, Ohio, United States

Site Status

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, United States

Site Status

Saint Alphonsus Medical Center-Baker City

Baker City, Oregon, United States

Site Status

Saint Charles Health System

Bend, Oregon, United States

Site Status

Clackamas Radiation Oncology Center

Clackamas, Oregon, United States

Site Status

Providence Oncology and Hematology Care Southeast

Clackamas, Oregon, United States

Site Status

Bay Area Hospital

Coos Bay, Oregon, United States

Site Status

Providence Newberg Medical Center

Newberg, Oregon, United States

Site Status

Saint Alphonsus Medical Center-Ontario

Ontario, 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

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Site Status

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, United States

Site Status

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, United States

Site Status

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, United States

Site Status

Roper Hospital

Charleston, South Carolina, United States

Site Status

Charleston Hematology Oncology Associates-Roper

Charleston, South Carolina, United States

Site Status

Lowcountry Hematology Oncology PA-North Charleston

Charleston, South Carolina, United States

Site Status

Bon Secours Saint Francis Hospital

Charleston, South Carolina, United States

Site Status

Charleston Hematology Oncology Associates PA-Saint Francis

Charleston, South Carolina, United States

Site Status

Lowcountry Hematology Oncology PA-West Ashley

Charleston, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Laurens

Clinton, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Easley

Easley, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Butternut

Greenville, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Faris

Greenville, South Carolina, United States

Site Status

Greenville Memorial Hospital

Greenville, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Eastside

Greenville, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Greer

Greer, South Carolina, United States

Site Status

Lowcountry Hematology Oncology PA-Mount Pleasant

Mt. Pleasant, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Seneca

Seneca, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Spartanburg

Spartanburg, South Carolina, United States

Site Status

Vanderbilt-Ingram Cancer Center Cool Springs

Franklin, Tennessee, United States

Site Status

Vanderbilt Breast Center at One Hundred Oaks

Nashville, Tennessee, United States

Site Status

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Providence Regional Cancer System-Aberdeen

Aberdeen, Washington, 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

Providence Regional Cancer System-Centralia

Centralia, Washington, United States

Site Status

Swedish Medical Center-Edmonds

Edmonds, Washington, United States

Site Status

Providence Regional Cancer Partnership

Everett, 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

Providence Regional Cancer System-Lacey

Lacey, Washington, United States

Site Status

PeaceHealth Saint John Medical Center

Longview, Washington, United States

Site Status

Pacific Gynecology Specialists

Seattle, Washington, United States

Site Status

Swedish Medical Center-Ballard Campus

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

Swedish Medical Center-Cherry Hill

Seattle, Washington, United States

Site Status

Providence Regional Cancer System-Shelton

Shelton, Washington, United States

Site Status

Rockwood Cancer Treatment Center-DHEC-Downtown

Spokane, Washington, United States

Site Status

Rockwood North Cancer Treatment Center

Spokane, Washington, United States

Site Status

Rockwood Clinic Cancer Treatment Center-Valley

Spokane Valley, Washington, United States

Site Status

PeaceHealth Southwest Medical Center

Vancouver, Washington, United States

Site Status

Providence Saint Mary Regional Cancer Center

Walla Walla, Washington, United States

Site Status

Providence Regional Cancer System-Yelm

Yelm, Washington, United States

Site Status

United Hospital Center

Bridgeport, West Virginia, United States

Site Status

WVUH-Berkely Medical Center

Martinsburg, West Virginia, United States

Site Status

West Virginia University Healthcare

Morgantown, West Virginia, United States

Site Status

Camden Clark Medical Center

Parkersburg, West Virginia, United States

Site Status

Ashland Memorial Medical Center

Ashland, Wisconsin, United States

Site Status

Duluth Clinic Ashland

Ashland, Wisconsin, United States

Site Status

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Site Status

Billings Clinic-Cody

Cody, Wyoming, United States

Site Status

Welch Cancer Center

Sheridan, Wyoming, United States

Site Status

BCCA-Vancouver Cancer Centre

Vancouver, British Columbia, Canada

Site Status

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status

Ottawa Hospital and Cancer Center-General Campus

Ottawa, Ontario, Canada

Site Status

Odette Cancer Centre- Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

CHUM - Hopital Notre-Dame

Montreal, Quebec, Canada

Site Status

CHUM - Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Site Status

Jewish General Hospital

Montreal, Quebec, Canada

Site Status

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

Sherbrooke, Quebec, Canada

Site Status

Countries

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United States Canada

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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NCI-2015-01348

Identifier Type: REGISTRY

Identifier Source: secondary_id

A221208

Identifier Type: -

Identifier Source: org_study_id

NCT02531659

Identifier Type: -

Identifier Source: nct_alias

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