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

February 23, 2023 updated by: Alliance for Clinical Trials in Oncology

Randomized Phase II Study: Corticosteroids + Bevacizumab vs. Corticosteroids + Placebo (BEST) for Radionecrosis After Radiosurgery for Brain Metastases

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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:

To evaluate the toxicity profile associated with bevacizumab and corticosteroid therapy.
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.
To compare intracranial progression-free survival and time to maximum radiographic response between treatment arms.
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.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 4E6
    - BCCA-Vancouver Cancer Centre
- Ontario
  - Hamilton, Ontario, Canada, L8V 5C2
    - Juravinski Cancer Centre at Hamilton Health Sciences
  - Ottawa, Ontario, Canada, K1H 8L6
    - Ottawa Hospital and Cancer Center-General Campus
  - Toronto, Ontario, Canada, M5G 2M9
    - University Health Network-Princess Margaret Hospital
  - Toronto, Ontario, Canada, M4N 3M5
    - Odette Cancer Centre- Sunnybrook Health Sciences Centre
- Quebec
  - Montreal, Quebec, Canada, H3T 1E2
    - Jewish General Hospital
  - Montreal, Quebec, Canada, H2L 4M1
    - CHUM - Hopital Notre-Dame
  - Montreal, Quebec, Canada, H2X 3E4
    - CHUM - Centre Hospitalier de l'Universite de Montreal
  - Sherbrooke, Quebec, Canada, J1H 5N4
    - Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
United States
- Alaska
  - Anchorage, Alaska, United States, 98508
    - Anchorage Associates in Radiation Medicine
  - Anchorage, Alaska, United States, 99508
    - Alaska Breast Care and Surgery LLC
  - Anchorage, Alaska, United States, 99508
    - Alaska Oncology and Hematology LLC
  - Anchorage, Alaska, United States, 99508
    - Alaska Women's Cancer Care
  - Anchorage, Alaska, United States, 99508
    - Anchorage Oncology Centre
  - Anchorage, Alaska, United States, 99508
    - Katmai Oncology Group
  - Anchorage, Alaska, United States, 99508
    - Providence Alaska Medical Center
  - Anchorage, Alaska, United States, 99504
    - Anchorage Radiation Therapy Center
- California
  - Arroyo Grande, California, United States, 93420
    - PCR Oncology
  - Burbank, California, United States, 91505
    - Providence Saint Joseph Medical Center/Disney Family Cancer Center
  - La Jolla, California, United States, 92093
    - UC San Diego Moores Cancer Center
- Delaware
  - Lewes, Delaware, United States, 19958
    - Beebe Medical Center
  - Newark, Delaware, United States, 19713
    - Helen F Graham Cancer Center
  - Newark, Delaware, United States, 19713
    - Delaware Clinical and Laboratory Physicians PA
  - Newark, Delaware, United States, 19713
    - Medical Oncology Hematology Consultants PA
  - Newark, Delaware, United States, 19718
    - Christiana Care Health System-Christiana Hospital
  - Newark, Delaware, United States, 19713
    - Regional Hematology and Oncology PA
  - Rehoboth Beach, Delaware, United States, 19971
    - Beebe Health Campus
  - Seaford, Delaware, United States, 19973
    - Nanticoke Memorial Hospital
  - Wilmington, Delaware, United States, 19801
    - Christiana Care Health System-Wilmington Hospital
- Florida
  - Boca Raton, Florida, United States, 33486
    - Boca Raton Regional Hospital
  - Daytona Beach, Florida, United States, 32114
    - Halifax Health Medical Center-Centers for Oncology
  - Jacksonville, Florida, United States, 32207
    - Baptist MD Anderson Cancer Center
  - Jacksonville, Florida, United States, 32224-9980
    - Mayo Clinic in Florida
  - Tampa, Florida, United States, 33612
    - Moffitt Cancer Center
- Georgia
  - Athens, Georgia, United States, 30607
    - University Cancer and Blood Center LLC
  - Atlanta, Georgia, United States, 30322
    - Emory University Hospital/Winship Cancer Institute
  - Savannah, Georgia, United States, 31404
    - Memorial Health University Medical Center
  - Savannah, Georgia, United States, 31404
    - Summit Cancer Care-Memorial
  - Savannah, Georgia, United States, 31405
    - Low Country Cancer Care Associates PC
  - Savannah, Georgia, United States, 31405
    - Summit Cancer Care-Candler
- Idaho
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Cancer Care Center-Boise
  - Boise, Idaho, United States, 83712
    - Saint Luke's Mountain States Tumor Institute
  - Caldwell, Idaho, United States, 83605
    - Saint Alphonsus Cancer Care Center-Caldwell
  - Coeur d'Alene, Idaho, United States, 83814
    - Kootenai Medical Center
  - Emmett, Idaho, United States, 83617
    - Walter Knox Memorial Hospital
  - Fruitland, Idaho, United States, 83619
    - Saint Luke's Mountain States Tumor Institute - Fruitland
  - Meridian, Idaho, United States, 83642
    - Idaho Urologic Institute-Meridian
  - Meridian, Idaho, United States, 83642
    - Saint Luke's Mountain States Tumor Institute - Meridian
  - Nampa, Idaho, United States, 83686
    - Saint Alphonsus Medical Center-Nampa
  - Nampa, Idaho, United States, 83686
    - Saint Luke's Mountain States Tumor Institute - Nampa
  - Post Falls, Idaho, United States, 83854
    - Kootenai Cancer Center
  - Sandpoint, Idaho, United States, 83864
    - Kootenai Cancer Clinic
  - Twin Falls, Idaho, United States, 83301
    - Saint Luke's Mountain States Tumor Institute-Twin Falls
- Illinois
  - Aurora, Illinois, United States, 60504
    - Rush - Copley Medical Center
  - Chicago, Illinois, United States, 60612
    - Rush University Medical Center
  - Chicago, Illinois, United States, 60612
    - University of Illinois
  - Danville, Illinois, United States, 61832
    - Carle on Vermilion
  - Effingham, Illinois, United States, 62401
    - Carle Physician Group-Effingham
  - Mattoon, Illinois, United States, 61938
    - Carle Physician Group-Mattoon/Charleston
  - Mount Vernon, Illinois, United States, 62864
    - Good Samaritan Regional Health Center
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center
  - Urbana, Illinois, United States, 61801
    - The Carle Foundation Hospital
  - Yorkville, Illinois, United States, 60560
    - Rush-Copley Healthcare Center
- Indiana
  - Evansville, Indiana, United States, 47713
    - Deaconess Clinic Downtown
  - Indianapolis, Indiana, United States, 46219
    - Community Cancer Center East
  - Indianapolis, Indiana, United States, 46227
    - Community Cancer Center South
  - Indianapolis, Indiana, United States, 46256
    - Community Cancer Center North
  - Kokomo, Indiana, United States, 46904
    - Community Howard Regional Health
  - Mishawaka, Indiana, United States, 46545
    - Memorial Regional Cancer Center Day Road
  - Newburgh, Indiana, United States, 47630
    - Chancellor Center for Oncology
  - Richmond, Indiana, United States, 47374
    - Reid Health
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
- Iowa
  - Des Moines, Iowa, United States, 50309
    - Iowa Methodist Medical Center
  - Des Moines, Iowa, United States, 50309
    - Medical Oncology and Hematology Associates-Des Moines
  - Des Moines, Iowa, United States, 50314
    - Broadlawns Medical Center
  - Des Moines, Iowa, United States, 50316
    - Iowa Lutheran Hospital
  - Fort Dodge, Iowa, United States, 50501
    - Trinity Regional Medical Center
  - West Des Moines, Iowa, United States, 50266-7700
    - Methodist West Hospital
- Kansas
  - Garden City, Kansas, United States, 67846
    - Central Care Cancer Center - Garden City
  - Great Bend, Kansas, United States, 67530
    - Central Care Cancer Center - Great Bend
  - Lenexa, Kansas, United States, 66219
    - Kansas Institute of Medicine Cancer and Blood Center
  - Lenexa, Kansas, United States, 66219
    - Minimally Invasive Surgery Hospital
  - Overland Park, Kansas, United States, 66209
    - Menorah Medical Center
  - Overland Park, Kansas, United States, 66213
    - Saint Luke's South Hospital
- Massachusetts
  - Springfield, Massachusetts, United States, 01104
    - Mercy Medical Center
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - University of Michigan Comprehensive Cancer Center
  - Ann Arbor, Michigan, United States, 48106
    - Saint Joseph Mercy Hospital
  - Brighton, Michigan, United States, 48114
    - Saint Joseph Mercy Brighton
  - Brighton, Michigan, United States, 48114
    - IHA Hematology Oncology Consultants-Brighton
  - Canton, Michigan, United States, 48188
    - Saint Joseph Mercy Canton
  - Canton, Michigan, United States, 48188
    - IHA Hematology Oncology Consultants-Canton
  - Caro, Michigan, United States, 48723
    - Caro Cancer Center
  - Chelsea, Michigan, United States, 48118
    - Saint Joseph Mercy Chelsea
  - Chelsea, Michigan, United States, 48118
    - IHA Hematology Oncology Consultants-Chelsea
  - Clarkston, Michigan, United States, 48346
    - Hematology Oncology Consultants-Clarkston
  - Clarkston, Michigan, United States, 48346
    - Newland Medical Associates-Clarkston
  - Dearborn, Michigan, United States, 48124
    - Beaumont Hospital-Dearborn
  - Detroit, Michigan, United States, 48236
    - Ascension Saint John Hospital
  - East China Township, Michigan, United States, 48054
    - Great Lakes Cancer Management Specialists-Doctors Park
  - Farmington Hills, Michigan, United States, 48336
    - Beaumont Hospital - Farmington Hills
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesee Cancer and Blood Disease Treatment Center
  - Flint, Michigan, United States, 48503
    - Genesee Hematology Oncology PC
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - Grosse Pointe, Michigan, United States, 48230
    - William Beaumont Hospital-Grosse Point
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Michigan Breast Specialists-Grosse Pointe Woods
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Lymphoma Clinic of Michigan
  - Jackson, Michigan, United States, 49201
    - Allegiance Health
  - Lansing, Michigan, United States, 48912
    - Sparrow Hospital
  - Livonia, Michigan, United States, 48154
    - Saint Mary Mercy Hospital
  - Livonia, Michigan, United States, 48154
    - Hope Cancer Clinic
  - Macomb, Michigan, United States, 48044
    - Great Lakes Cancer Management Specialists-Macomb Medical Campus
  - Macomb, Michigan, United States, 48044
    - Michigan Breast Specialists-Macomb Township
  - Marlette, Michigan, United States, 48453
    - Saint Mary's Oncology/Hematology Associates of Marlette
  - Novi, Michigan, United States, 48374
    - Ascension Providence Hospitals - Novi
  - Pontiac, Michigan, United States, 48341
    - Saint Joseph Mercy Oakland
  - Pontiac, Michigan, United States, 48341
    - 21st Century Oncology-Pontiac
  - Pontiac, Michigan, United States, 48341
    - Hope Cancer Center
  - Pontiac, Michigan, United States, 48341
    - Newland Medical Associates-Pontiac
  - Port Huron, Michigan, United States, 48060
    - Lake Huron Medical Center
  - Port Huron, Michigan, United States, 48060
    - Huron Medical Center PC
  - Rochester Hills, Michigan, United States, 48309
    - Great Lakes Cancer Management Specialists-Rochester Hills
  - Roseville, Michigan, United States, 48066
    - Michigan Cancer Specialists
  - Royal Oak, Michigan, United States, 48073
    - William Beaumont Hospital-Royal Oak
  - Royal Oak, Michigan, United States, 48067
    - Oakland Colon and Rectal Association
  - Royal Oak, Michigan, United States, 48073
    - Cancer Care Associates PC
  - Royal Oak, Michigan, United States, 48073
    - Comprehensive Medical Center PLLC
  - Royal Oak, Michigan, United States, 48073
    - Hematology Oncology Consultants PC
  - Royal Oak, Michigan, United States, 48073
    - Oakland Medical Group
  - Saginaw, Michigan, United States, 48601
    - Saint Mary's of Michigan
  - Saginaw, Michigan, United States, 48604
    - Oncology Hematology Associates of Saginaw Valley PC
  - Southfield, Michigan, United States, 48075
    - Ascension Providence Hospitals - Southfield
  - Sterling Heights, Michigan, United States, 48312
    - Bhadresh Nayak MD PC-Sterling Heights
  - Sterling Heights, Michigan, United States, 48312
    - Premier Hematology Oncology Care
  - Sterling Heights, Michigan, United States, 48314
    - Mitchell Folbe MD PC
  - Tawas City, Michigan, United States, 48764
    - Saint Joseph Health System-Tawas City
  - Troy, Michigan, United States, 48085
    - William Beaumont Hospital - Troy
  - Troy, Michigan, United States, 48084
    - Michigan Institute of Urology-Town Center
  - Troy, Michigan, United States, 48085
    - Claudia BR Herke MD PC
  - Troy, Michigan, United States, 48098
    - Hematology Oncology Consultants PC-Troy
  - Warren, Michigan, United States, 48093
    - Saint John Macomb-Oakland Hospital
  - Warren, Michigan, United States, 48088
    - Advanced Breast Care Center PLLC
  - Warren, Michigan, United States, 48093
    - Great Lakes Cancer Management Specialists-Macomb Professional Building
  - Warren, Michigan, United States, 48093
    - Macomb Hematology Oncology PC
  - Warren, Michigan, United States, 48093
    - Michigan Breast Specialists-Warren
  - Warren, Michigan, United States, 48093
    - Bhadresh Nayak MD PC-Warren
  - West Branch, Michigan, United States, 48661
    - Saint Mary's Oncology/Hematology Associates of West Branch
  - Ypsilanti, Michigan, United States, 48106
    - Huron Gastroenterology PC
  - Ypsilanti, Michigan, United States, 48197
    - IHA Hematology Oncology Consultants-Ann Arbor
- Minnesota
  - Brainerd, Minnesota, United States, 56401
    - Essentia Health Saint Joseph's Medical Center
  - Deer River, Minnesota, United States, 56636
    - Essentia Health - Deer River Clinic
  - Detroit Lakes, Minnesota, United States, 56501
    - Essentia Health Saint Mary's - Detroit Lakes Clinic
  - Duluth, Minnesota, United States, 55805
    - Essentia Health Cancer Center
  - Duluth, Minnesota, United States, 55805
    - Essentia Health Saint Mary's Medical Center
  - Duluth, Minnesota, United States, 55805
    - Miller-Dwan Hospital
  - Fergus Falls, Minnesota, United States, 56537
    - Lake Region Healthcare Corporation-Cancer Care
  - Fosston, Minnesota, United States, 56542
    - Essentia Health - Fosston
  - Hibbing, Minnesota, United States, 55746
    - Essentia Health Hibbing Clinic
  - Park Rapids, Minnesota, United States, 56470
    - Essentia Health - Park Rapids
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic
  - Sandstone, Minnesota, United States, 55072
    - Essentia Health Sandstone
  - Virginia, Minnesota, United States, 55792
    - Essentia Health Virginia Clinic
- Missouri
  - Ballwin, Missouri, United States, 63011
    - Saint Louis Cancer and Breast Institute-Ballwin
  - Bolivar, Missouri, United States, 65613
    - Central Care Cancer Center - Bolivar
  - Branson, Missouri, United States, 65616
    - Cox Cancer Center Branson
  - Creve Coeur, Missouri, United States, 63141
    - Siteman Cancer Center at West County Hospital
  - Independence, Missouri, United States, 64057
    - Centerpoint Medical Center LLC
  - Joplin, Missouri, United States, 64804
    - Freeman Health System
  - Joplin, Missouri, United States, 64804
    - Mercy Hospital Joplin
  - Kansas City, Missouri, United States, 64111
    - Saint Luke's Hospital of Kansas City
  - Kansas City, Missouri, United States, 64132
    - Research Medical Center
  - Lee's Summit, Missouri, United States, 64086
    - Saint Luke's East - Lee's Summit
  - Rolla, Missouri, United States, 65401
    - Delbert Day Cancer Institute at PCRMC
  - Rolla, Missouri, United States, 65401
    - Mercy Clinic-Rolla-Cancer and Hematology
  - Saint Joseph, Missouri, United States, 64507
    - Heartland Regional Medical Center
  - Saint Louis, Missouri, United States, 63110
    - Washington University School of Medicine
  - Saint Louis, Missouri, United States, 63109
    - Saint Louis Cancer and Breast Institute-South City
  - Saint Peters, Missouri, United States, 63376
    - Siteman Cancer Center at Saint Peters Hospital
  - Springfield, Missouri, United States, 65807
    - CoxHealth South Hospital
  - Springfield, Missouri, United States, 65804
    - Mercy Hospital Springfield
  - Washington, Missouri, United States, 63090
    - Mercy Hospital Washington
- Montana
  - Anaconda, Montana, United States, 59711
    - Community Hospital of Anaconda
  - Billings, Montana, United States, 59101
    - Billings Clinic Cancer Center
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Hospital
  - Great Falls, Montana, United States, 59405
    - Great Falls Clinic
  - Great Falls, Montana, United States, 59405
    - Benefis Healthcare- Sletten Cancer Institute
  - Helena, Montana, United States, 59601
    - Saint Peter's Community Hospital
  - Kalispell, Montana, United States, 59901
    - Kalispell Regional Medical Center
  - Missoula, Montana, United States, 59804
    - Community Medical Hospital
- Nevada
  - Carson City, Nevada, United States, 89703
    - Carson Tahoe Regional Medical Center
  - Henderson, Nevada, United States, 89052
    - Comprehensive Cancer Centers of Nevada - Henderson
  - Henderson, Nevada, United States, 89052
    - Cancer and Blood Specialists-Henderson
  - Henderson, Nevada, United States, 89052
    - Las Vegas Cancer Center-Henderson
  - Henderson, Nevada, United States, 89074
    - Comprehensive Cancer Centers of Nevada-Southeast Henderson
  - Henderson, Nevada, United States, 89074
    - 21st Century Oncology-Henderson
  - Henderson, Nevada, United States, 89052
    - Comprehensive Cancer Centers of Nevada-Horizon Ridge
  - Henderson, Nevada, United States, 89052
    - Nevada Cancer Specialists-Saint Rose
  - Las Vegas, Nevada, United States, 89144
    - Summerlin Hospital Medical Center
  - Las Vegas, Nevada, United States, 89106
    - Radiation Oncology Centers of Nevada Central
  - Las Vegas, Nevada, United States, 89119
    - Radiation Oncology Centers of Nevada Southeast
  - Las Vegas, Nevada, United States, 89128
    - Comprehensive Cancer Centers of Nevada - Northwest
  - Las Vegas, Nevada, United States, 89144
    - Comprehensive Cancer Centers of Nevada-Summerlin
  - Las Vegas, Nevada, United States, 89148
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, United States, 89169
    - Comprehensive Cancer Centers of Nevada - Central Valley
  - Las Vegas, Nevada, United States, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, United States, 89106
    - Cancer and Blood Specialists-Shadow
  - Las Vegas, Nevada, United States, 89109
    - HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
  - Las Vegas, Nevada, United States, 89113
    - HealthCare Partners Medical Group Oncology/Hematology-San Martin
  - Las Vegas, Nevada, United States, 89121
    - Cancer Therapy and Integrative Medicine
  - Las Vegas, Nevada, United States, 89128
    - Cancer and Blood Specialists-Tenaya
  - Las Vegas, Nevada, United States, 89128
    - HealthCare Partners Medical Group Oncology/Hematology-Tenaya
  - Las Vegas, Nevada, United States, 89148-2405
    - Las Vegas Cancer Center-Medical Center
  - Las Vegas, Nevada, United States, 89149
    - HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
  - Las Vegas, Nevada, United States, 89109
    - 21st Century Oncology
  - Las Vegas, Nevada, United States, 89128
    - 21st Century Oncology-Vegas Tenaya
  - Las Vegas, Nevada, United States, 89148
    - 21st Century Oncology-Fort Apache
  - Las Vegas, Nevada, United States, 89148
    - Nevada Cancer Specialists-Fort Apache
  - Las Vegas, Nevada, United States, 89128
    - Ann M Wierman MD LTD
  - Las Vegas, Nevada, United States, 89102
    - Desert West Surgery
  - Las Vegas, Nevada, United States, 89169
    - University Cancer Center
  - Las Vegas, Nevada, United States, 89128
    - Nevada Cancer Specialists-Tenaya
  - Las Vegas, Nevada, United States, 89102
    - Nevada Cancer Specialists?Oakey
  - Pahrump, Nevada, United States, 89048
    - Hope Cancer Care of Nevada-Pahrump
  - Reno, Nevada, United States, 89502
    - Renown Regional Medical Center
  - Reno, Nevada, United States, 89503
    - Saint Mary's Regional Medical Center
  - Reno, Nevada, United States, 89509
    - Radiation Oncology Associates
- New Hampshire
  - Concord, New Hampshire, United States, 03301
    - New Hampshire Oncology Hematology PA-Concord
  - Hooksett, New Hampshire, United States, 03106
    - New Hampshire Oncology Hematology PA-Hooksett
- New Jersey
  - Englewood, New Jersey, United States, 07631
    - Englewood Hospital and Medical Center
  - Summit, New Jersey, United States, 07902
    - Overlook Hospital
- New York
  - Buffalo, New York, United States, 14263
    - Roswell Park Cancer Institute
  - New York, New York, United States, 10016
    - Laura and Isaac Perlmutter Cancer Center at NYU Langone
  - Rochester, New York, United States, 14642
    - University of Rochester
- North Carolina
  - Asheboro, North Carolina, United States, 27203
    - Randolph Hospital
  - Burlington, North Carolina, United States, 27215
    - Cone Health Cancer Center at Alamance Regional
  - Chapel Hill, North Carolina, United States, 27599
    - UNC Lineberger Comprehensive Cancer Center
  - Charlotte, North Carolina, United States, 28203
    - Carolinas Medical Center/Levine Cancer Institute
  - Clinton, North Carolina, United States, 28328
    - Southeastern Medical Oncology Center-Clinton
  - Goldsboro, North Carolina, United States, 27534
    - Southeastern Medical Oncology Center-Goldsboro
  - Goldsboro, North Carolina, United States, 27534
    - Wayne Memorial Hospital
  - Greensboro, North Carolina, United States, 27403
    - Cone Health Cancer Center
  - Greenville, North Carolina, United States, 27834
    - East Carolina University
  - Jacksonville, North Carolina, United States, 28546
    - Southeastern Medical Oncology Center-Jacksonville
  - Jacksonville, North Carolina, United States, 28546
    - Onslow Memorial Hospital
  - Mebane, North Carolina, United States, 27302
    - Cone Heath Cancer Center at Mebane
  - Reidsville, North Carolina, United States, 27320
    - Annie Penn Memorial Hospital
  - Wilson, North Carolina, United States, 27893
    - Southeastern Medical Oncology Center-Wilson
  - Winston-Salem, North Carolina, United States, 27157
    - Wake Forest University Health Sciences
- North Dakota
  - Fargo, North Dakota, United States, 58103
    - Essentia Health Cancer Center-South University Clinic
  - Jamestown, North Dakota, United States, 58401
    - Essentia Health - Jamestown Clinic
- Ohio
  - Akron, Ohio, United States, 44307
    - Cleveland Clinic Akron General
  - Beavercreek, Ohio, United States, 45431
    - Indu and Raj Soin Medical Center
  - Centerville, Ohio, United States, 45459
    - Miami Valley Hospital South
  - Centerville, Ohio, United States, 45459
    - Dayton Physicians LLC-Miami Valley South
  - Cincinnati, Ohio, United States, 45236
    - Oncology Hematology Care Inc-Kenwood
  - Dayton, Ohio, United States, 45406
    - Good Samaritan Hospital - Dayton
  - Dayton, Ohio, United States, 45409
    - Miami Valley Hospital
  - Dayton, Ohio, United States, 45415
    - Miami Valley Hospital North
  - Dayton, Ohio, United States, 45415
    - Dayton Physicians LLC-Samaritan North
  - Findlay, Ohio, United States, 45840
    - Blanchard Valley Hospital
  - Findlay, Ohio, United States, 45840
    - Armes Family Cancer Center
  - Findlay, Ohio, United States, 45840
    - Orion Cancer Care
  - Franklin, Ohio, United States, 45005-1066
    - Atrium Medical Center-Middletown Regional Hospital
  - Franklin, Ohio, United States, 45005
    - Dayton Physicians LLC-Atrium
  - Greenville, Ohio, United States, 45331
    - Wayne Hospital
  - Greenville, Ohio, United States, 45331
    - Dayton Physicians LLC-Wayne
  - Kettering, Ohio, United States, 45429
    - Kettering Medical Center
  - Kettering, Ohio, United States, 45409
    - Greater Dayton Cancer Center
  - Kettering, Ohio, United States, 45420
    - First Dayton Cancer Care
  - Middletown, Ohio, United States, 45042
    - Dayton Physicians LLC-Signal Point
  - Sidney, Ohio, United States, 45365
    - Dayton Physicians LLC-Wilson
  - Springfield, Ohio, United States, 45505
    - Springfield Regional Medical Center
  - Springfield, Ohio, United States, 45504
    - Springfield Regional Cancer Center
  - Troy, Ohio, United States, 45373
    - Upper Valley Medical Center
  - Troy, Ohio, United States, 45373
    - Dayton Physicians LLC-Upper Valley
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73120
    - Mercy Hospital Oklahoma City
- Oregon
  - Baker City, Oregon, United States, 97814
    - Saint Alphonsus Medical Center-Baker City
  - Bend, Oregon, United States, 97701
    - Saint Charles Health System
  - Clackamas, Oregon, United States, 97015
    - Clackamas Radiation Oncology Center
  - Clackamas, Oregon, United States, 97015
    - Providence Oncology and Hematology Care Southeast
  - Coos Bay, Oregon, United States, 97420
    - Bay Area Hospital
  - Newberg, Oregon, United States, 97132
    - Providence Newberg Medical Center
  - Ontario, Oregon, United States, 97914
    - Saint Alphonsus Medical Center-Ontario
  - Oregon City, Oregon, United States, 97045
    - Providence Willamette Falls Medical Center
  - Portland, Oregon, United States, 97213
    - Providence Portland Medical Center
  - Portland, Oregon, United States, 97225
    - Providence Saint Vincent Medical Center
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18103
    - Lehigh Valley Hospital-Cedar Crest
  - Bethlehem, Pennsylvania, United States, 18017
    - Lehigh Valley Hospital - Muhlenberg
  - Chadds Ford, Pennsylvania, United States, 19317
    - Christiana Care Health System-Concord Health Center
- South Carolina
  - Charleston, South Carolina, United States, 29401
    - Roper Hospital
  - Charleston, South Carolina, United States, 29403
    - Charleston Hematology Oncology Associates-Roper
  - Charleston, South Carolina, United States, 29406
    - Lowcountry Hematology Oncology PA-North Charleston
  - Charleston, South Carolina, United States, 29414
    - Bon Secours Saint Francis Hospital
  - Charleston, South Carolina, United States, 29414
    - Lowcountry Hematology Oncology PA-West Ashley
  - Charleston, South Carolina, United States, 29414
    - Charleston Hematology Oncology Associates PA-Saint Francis
  - Clinton, South Carolina, United States, 29325
    - Greenville Health System Cancer Institute-Laurens
  - Easley, South Carolina, United States, 29640
    - Greenville Health System Cancer Institute-Easley
  - Greenville, South Carolina, United States, 29605
    - Greenville Health System Cancer Institute-Faris
  - Greenville, South Carolina, United States, 29605
    - Greenville Memorial Hospital
  - Greenville, South Carolina, United States, 29615
    - Greenville Health System Cancer Institute-Eastside
  - Greenville, South Carolina, United States, 29605
    - Greenville Health System Cancer Institute-Butternut
  - Greer, South Carolina, United States, 29650
    - Greenville Health System Cancer Institute-Greer
  - Mount Pleasant, South Carolina, United States, 29464
    - Lowcountry Hematology Oncology PA-Mount Pleasant
  - Seneca, South Carolina, United States, 29672
    - Greenville Health System Cancer Institute-Seneca
  - Spartanburg, South Carolina, United States, 29307
    - Greenville Health System Cancer Institute-Spartanburg
- Tennessee
  - Franklin, Tennessee, United States, 37067
    - Vanderbilt-Ingram Cancer Center Cool Springs
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt University/Ingram Cancer Center
  - Nashville, Tennessee, United States, 37204
    - Vanderbilt Breast Center at One Hundred Oaks
- Texas
  - Houston, Texas, United States, 77030
    - M D Anderson Cancer Center
- Washington
  - Aberdeen, Washington, United States, 98520
    - Providence Regional Cancer System-Aberdeen
  - Anacortes, Washington, United States, 98221
    - Cancer Care Center at Island Hospital
  - Bellingham, Washington, United States, 98225
    - PeaceHealth Saint Joseph Medical Center
  - Centralia, Washington, United States, 98531
    - Providence Regional Cancer System-Centralia
  - Edmonds, Washington, United States, 98026
    - Swedish Medical Center-Edmonds
  - Everett, Washington, United States, 98201
    - Providence Regional Cancer Partnership
  - Issaquah, Washington, United States, 98029
    - Swedish Cancer Institute-Issaquah
  - Kennewick, Washington, United States, 99336
    - Kadlec Clinic Hematology and Oncology
  - Lacey, Washington, United States, 98503
    - Providence Regional Cancer System-Lacey
  - Longview, Washington, United States, 98632
    - PeaceHealth Saint John Medical Center
  - Seattle, Washington, United States, 98107
    - Swedish Medical Center-Ballard Campus
  - Seattle, Washington, United States, 98112
    - Kaiser Permanente Washington
  - Seattle, Washington, United States, 98104
    - Pacific Gynecology Specialists
  - Seattle, Washington, United States, 98122-4307
    - Swedish Medical Center-First Hill
  - Seattle, Washington, United States, 98122-5711
    - Swedish Medical Center-Cherry Hill
  - Shelton, Washington, United States, 98584
    - Providence Regional Cancer System-Shelton
  - Spokane, Washington, United States, 99204
    - Rockwood Cancer Treatment Center-DHEC-Downtown
  - Spokane, Washington, United States, 99218
    - Rockwood North Cancer Treatment Center
  - Spokane Valley, Washington, United States, 99216
    - Rockwood Clinic Cancer Treatment Center-Valley
  - Vancouver, Washington, United States, 98664
    - PeaceHealth Southwest Medical Center
  - Walla Walla, Washington, United States, 99362
    - Providence Saint Mary Regional Cancer Center
  - Yelm, Washington, United States, 98597
    - Providence Regional Cancer System-Yelm
- West Virginia
  - Bridgeport, West Virginia, United States, 26330
    - United Hospital Center
  - Martinsburg, West Virginia, United States, 25401
    - WVUH-Berkely Medical Center
  - Morgantown, West Virginia, United States, 26506
    - West Virginia University Healthcare
  - Parkersburg, West Virginia, United States, 26101
    - Camden Clark Medical Center
- Wisconsin
  - Ashland, Wisconsin, United States, 54806
    - Duluth Clinic Ashland
  - Ashland, Wisconsin, United States, 54806
    - Ashland Memorial Medical Center
  - Madison, Wisconsin, United States, 53792
    - University of Wisconsin Hospital and Clinics
- Wyoming
  - Cody, Wyoming, United States, 82414
    - Billings Clinic-Cody
  - Sheridan, Wyoming, United States, 82801
    - Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Pre-Registration Eligibility Criteria:

Patients who present with symptomatic brain radionecrosis after they have received radiosurgery for brain metastases from primary solid tumor including but not limited to lung, breast, colorectal cancer but excluding melanoma, choriocarcinoma, renal cell carcinoma or gliomas
Patients at institutions that elect to utilize central imaging review to confirm eligibility must be pre-registered prior to submission of these images; images should be submitted as soon as possible after the pre-registration magnetic resonance imaging (MRI) is obtained; turnaround time for this review will be =< 72 business hours after receipt of images by the Imaging and Radiation Oncology Core (IROC)
Patients at institutions that elect to confirm eligibility locally may be pre-registered at the same time as they are randomized

Registration/Randomization Eligibility Criteria:

A diagnosis of radionecrosis will be based on a clinical onset of symptoms and radiological findings of radionecrosis at 3-24 months following radiosurgery, with or without pathological confirmation.
1.1 'Symptomatic' brain radionecrosis to at least one lesion following radiosurgery treatment for brain metastases where 'symptomatic' is defined as:
1.1.1 New or increasing headache associated with mass effect, sensory or motor abnormality, cognitive changes, speech difficulty, balance or coordination difficulty, cranial nerve deficits
1.1.2 Symptoms are persistent or worsening despite administration of at least dexamethasone 4 mg (or equivalent corticosteroid) daily for 1 week
1.2 Clinical eligibility supported by central imaging real-time review. The presence of at least the following conventional MR image characteristic:
1.2.1 Conventional MR - Lesion quotient of < 0.3, where lesion quotient is defined as the proportional value of the maximum axial cross-sectional area of the T2-weighted defined lesion over the maximum axial cross-sectional area of the contrast-enhancing lesion on the T1-weighted post-gadolinium sequence on a comparable axial slice. If the conventional MR findings are not seen, the following dynamic susceptibility-contrast (DSC) MR characteristics may be used to meet eligibility for this study.
1.2.2 DSC MR - The cut-offs below will be based on GRE EPI DSC perfusion images, acquired without using a gadolinium pre-load:
1.2.2.1 Relative cerebral blood volume (rCBV) <1.5 in the enhancing- lesion relative to normal-appearing white matter (NAWM)
1.2.2.2. Percentage of signal recovery (PSR) > 76%, where PSR is determined by comparing the lower signal intensity during passage of the contrast bolus with the post-contrast signal intensity on the signal intensity-time curve
1.2.3 Centers that standardly use PET or MRS to determine a diagnosis of radionecrosis are permitted to use these modalities to assist in their patient selection; however the criteria described for conventional MR and/or DSC should also be met for study eligibility. Both PET and MRS are not mandatory for study eligibility.
Prior to start of treatment
2.1 Must have been taking a stable dose of corticosteroids for symptom management for at least 1 week before baseline MRI.
2.2 No systemic therapy within 2 weeks prior to registration or plan for systemic therapy within the first 8 weeks after study registration. The protocol provides a list of 'approved systemic' therapies that are allowed for concurrent use with bevacizumab.
2.3 No bevacizumab ≤ 3 months of study registration.
2.4 Central imaging real-time review (72 hour turn around) to confirm eligibility.
Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done ≤ 14 days prior to registration and confirmation they are not nursing is required.
Age ≥ 18 years
Karnofsky Performance Status ≥ 60%
Required Initial Laboratory Values ≤14 days of registration:
6.1 Absolute Neutrophil Count (ANC) ≥ 1,500/mm^3
6.2 Platelet Count ≥ 100,000/mm3
6.3 Hemoglobin ≥ 10 g/dL*
6.3.1 allowing transfusion or other intervention to achieve this minimum hemoglobin
6.4 BUN < 30 mg/dL
6.5 Creatinine < 1.7 mg/dL
6.6 Bilirubin ≤ 2.0 mg/dL
6.7 ALT ≤ 3.0 x upper limits of normal (ULN)
6.8 AST ≤ 3.0 x ULN
6.9 INR <1.5 x ULN**
6.9.1 unless patients are receiving anti-coagulation therapy. Patients receiving anti-coagulation therapy with an agent such warfarin or heparin are allowed to participate if INR ≤ 3.0.**
6.10 UPC Ratio <0.5 or if ≥ 0.5
6.10.1 24-hour urine protein must be <1000 mg
Able to participate in patient-report outcomes (MDASI-BT, DSQ-C, LASA) questionnaires.
Assistance by research personnel is acceptable if participant has disabilities that make reading or writing difficult.
No evidence of recent hemorrhage at pre-registration MRI of the brain, however the following are permitted: presence of hemosiderin, resolving hemorrhagic changes related to surgery, and presence of punctate hemorrhage in the tumor.
No excess risk of bleeding (any of the following):
9.1 Bleeding diathesis or coagulopathy
9.2 Thrombocytopenia
9.3 Major surgical procedure, open biopsy, or significant traumatic injury within the past 28 days or anticipation of need for major surgical procedure during the course of the study.
9.4 Minor surgical procedures, stereotactic biopsy, fine needle aspiration, or core biopsy within the past 7 days.
No clinically significant cardiovascular disease.
10.1 No uncontrolled hypertension (systolic blood pressure ≤ 160 mm Hg or diastolic ≤ 100 mm Hg). Patients with hypertension must be adequately controlled with appropriate anti-hypertensive therapy or diet.
10.2 No history of arterial thrombotic events within the past 6 months, including:
10.2.1 transient ischemic attack (TIA)
10.2.2 cerebrovascular accident (CVA)
10.2.3 peripheral arterial thrombus
10.2.4 unstable angina or angina requiring surgical or medial intervention
10.2.5 myocardial infarction (MI)
10.2.6 significant peripheral artery disease (i.e., claudication on less than one block)
10.2.7 significant vascular disease (i.e., aortic aneurysm, history of aortic dissection)
10.3 Patients who have had a deep vein thrombosis or pulmonary embolus within the past 6 months are eligible if they are on stable therapeutic anticoagulation.
10.4 No current New York Heart Association classification II, III, or IV congestive heart failure.
No history of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within past 12 months.
No central lung metastases with excessive active bleeding.
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.
No history of serious non-healing wound, ulcer, or bone fractures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: bevacizumab IV Drug: corticosteroids IV
Experimental: 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.	Drug: corticosteroids IV Other: placebo IV

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Drug: bevacizumab

Drug: corticosteroids

Experimental: 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.

Drug: corticosteroids

Other: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in M. D. Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score Time Frame: Baseline, 2, 4, 6 and 8 weeks	The MD Anderson Symptom Inventory for brain tumor (MDASI-BT) is a 28-item multi-symptom patient-reported outcome measure assessing the severity of symptoms experienced by cancer patients and the interference with daily living caused by these symptoms, with 9 items specific to brain tumors. Each item ranges from 0 (best condition) to 10 (worst condition). A subscale score (Symptom Severity) is the average of the subscale items with 0 being "not present" and 10 being "as bad as you can imagine.", given that a specified minimum numbers of items were completed. A negative change in score from baseline to given time point indicates a worsening score.	Baseline, 2, 4, 6 and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity (CTCAE Version 4.0) Time Frame: Up to 1.5 years post-treatment	Toxicity associated with bevacizumab and corticosteroids in patients with radionecrosis using CTCAE Version 4.0. The number of patients reporting a grade 3 or higher, 4 or higher, or 5 at least possibly related to treatment are included in this table.	Up to 1.5 years post-treatment
Quality of Life Measure Using the Single Item Linear Analogue Scale (LASA) Time Frame: Up to 1.5 years post-treatment	The Linear Analogue Scale used is a 5-question survey. Patients are asked to score the following questions on a 1(as bad as it can be) -10 (as good as it can be) scale: 1) your overall quality of life, 2) your overall (intellectual) well being, 3) your overall physical well being, 4) your overall emotional well being, and 5) your overall spiritual well being. The change in score was computed from baseline to 1.5 years post-treatment. A negative difference is thought of as a worsening score from baseline.	Up to 1.5 years post-treatment
Quality of Life Measure Using the Dexamethasone Symptoms Questionnaire - Chronic (DSQ-C) Time Frame: Baseline and weeks 2, 4, 6, 8 of treatment	The DSQ-C was developed for use in the brain tumor patient population. It consists of 18 questions rated on a 4-point scale (1 to 4, with 4 indicating a worse symptom) to indicate the presence and severity of symptoms. For each patient, the sum across all 18 questions were computed(18-72, with 18 being a score of 1 for each of the 18 questions and 72 being a score of 4 for each of the questions, refering to the previous sentence, a score of 18(a score of 1, 18 times) indicates the best possible score. A score of 72(a score of 4, 18 times) indicates the worst possible. The mean for total score across each week (weeks 2, 4, 6, 8) is reported.	Baseline and weeks 2, 4, 6, 8 of treatment
Quality of Life Measure Using the The M. D. Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Score. Time Frame: Up to 1.5 years post-treatment	The MDASI-BT was developed and validated for use in the brain tumor patient population, including those with brain metastases and typically requires less than 4 minutes to complete. It consists of 23 symptoms rated on a 0 to 10 numerical rating scale (NRS) to indicate the presence and severity of the symptom, with 0 being "not present" and 10 being "as bad as you can imagine." MDASI-BT Symptom Scoring: A global symptom score for the MDASI symptom severity scale is obtained by taking the average of the 23 items together. This puts the score on a 0-10 scalenumerical rating scale (NRS) to indicate the presence and severity of the symptom, with 0 being "not present" and 10 being "as bad as you can imagine." The mean global symptom at baseline and at weeks 2, 4, 6, 8 were used in this analysis.	Up to 1.5 years post-treatment
Progression Free Survival Time Frame: Up to 16 weeks	Progression free survival is defined as the time from start of treatment to the earliest of the date patient stops placebo or bevacizumab for either alternative therapy or crossover to bevacizumab (if initially on placebo). Result will be summarized by Kaplan-Meier method.	Up to 16 weeks
Time to Maximum Radiographic Response Time Frame: Up to 16 weeks	Time from start of treatment to maximum radiographic response	Up to 16 weeks
Time to Stopping Corticosteroids Time Frame: Up to 16 weeks	Time to stopping corticosteroids is defined as the time from start of protocol treatment to the last day corticosteroids were given. Time to stopping corticosteroid will be summarized by Kaplan-Meier curve with log-rank tests conducted to investigate differences between treatment arms.	Up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Genentech, Inc.

Investigators

Study Chair: Caroline Chung, MD, M.D. Anderson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

December 15, 2022

Study Registration Dates

First Submitted

July 2, 2015

First Submitted That Met QC Criteria

July 6, 2015

First Posted (Estimate)

July 7, 2015

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

February 23, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

A221208
NCI-2015-01348 (Registry Identifier: NCI Clinical Trials Reporting Program)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Brain Metastases

Clinical Trials on bevacizumab

Search Similar Trials

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Medical Conditions

Drug Interventions

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations