Whole-Brain Radiation Therapy or Stereotactic Radiosurgery With or Without Lapatinib Ditosylate in Treating Patients With Brain Metastasis From HER2-Positive Breast Cancer
Phase II Randomized Study of Whole Brain Radiotherapy/Stereotactic Radiosurgery in Combination With Concurrent Lapatinib in Patients With Brain Metastasis From HER2-Positive Breast Cancer - A Collaborative Study of NRG Oncology and KROG
5 other identifiers
interventional
143
3 countries
302
Brief Summary
This randomized phase II trial studies how well whole-brain radiation therapy or stereotactic radiosurgery with or without lapatinib ditosylate works in treating patients with breast cancer that has too many of a protein called human epidermal growth factor receptor 2 (HER2) on its cells and has spread to the brain. Radiation therapy uses high energy x rays to kill tumor cells and shrink tumors. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether whole-brain radiation therapy or stereotactic radiosurgery together with lapatinib ditosylate is an effective treatment for brain metastasis from breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2012
Longer than P75 for phase_2
302 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2012
CompletedFirst Posted
Study publicly available on registry
June 19, 2012
CompletedStudy Start
First participant enrolled
December 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedResults Posted
Study results publicly available
April 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2022
CompletedOctober 17, 2023
September 1, 2023
7.1 years
June 15, 2012
February 10, 2021
September 22, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Complete Response (CR) Rate in the Brain at 12 Weeks Post-radiation Therapy (RT) Using the RECIST 1.1 Criteria Based on Brain Magnetic Resonance Imaging (MRI)
The Response Evaluation Criteria in Solid Tumors (RECIST) criteria evaluates changes in the largest diameter (unidimensional measurement) of the tumor lesions. Complete response is defined as the complete disappearance of all enhancing disease and off all steroids. Rate is calculated by dividing the number of patients with complete response by the number of analyzable patients.
Baseline and 12 weeks post RT (approximately 12 weeks from start of treatment if SRS and 15 if WBRT)
Secondary Outcomes (10)
Complete Response Rate in the Brain at 4 Weeks Post-RT Using the RECIST 1.1 Criteria Based on Brain MRI
Baseline and 4 weeks post RT (approximately 4 weeks from start of treatment if SRS and 7 if WBRT)
Complete Response Rate in the Brain Using the World Health Organization (WHO)/Modified McDonald Criteria Based on Brain MRI
Baseline, 4 and 12 weeks post RT (approximately 4 and 12 weeks from start of treatment if SRS, 7 and 15 if WBRT)
Objective Response Rate in the Brain Using the RECIST 1.1 Criteria Based on Brain MRI
Baseline, 4 and 12 weeks post RT (approximately 4 and 12 weeks from start of treatment if SRS, 7 and 15 if WBRT)
Percentage of Participants With Progression in the Brain Outside the Targeted Measurable Disease Using the RECIST 1.1 Criteria Based on Brain MRI
From randomization to last follow-up. MRIs occurred at baseline, 4 and 12 weeks post RT, then every 12 weeks thereafter until progression. Maximum follow-up at time of analysis was 71.6 months.
Targeted Lesion-specific Objective Response Rate Using the RECIST 1.1 Measurement Criteria Based on Brain MRI
Baseline, 4 and 12 weeks post RT (approximately 4 and 12 weeks from start of treatment if SRS, 7 and 15 if WBRT)
- +5 more secondary outcomes
Study Arms (2)
Arm A (WBRT or SRS)
EXPERIMENTALPatients undergo WBRT 5 days a week for 3 weeks for a total of 15 treatments, or SRS for 1 treatment.
Arm B (lapatinib ditosylate, WBRT or SRS)
EXPERIMENTALPatients undergo WBRT or SRS as in Arm A. Patients also receive lapatinib ditosylate PO QD for 6 weeks.
Interventions
Correlative studies
Undergo SRS
Undergo WBRT
Eligibility Criteria
You may qualify if:
- Pathologically (histologically or cytologically) proven diagnosis of invasive breast cancer
- HER2-overexpressing breast cancer (3+ staining by immunohistochemistry or HER2 gene amplification by fluorescent in situ hybridization \[FISH\] or silver in situ hybridization \[SISH\] \>= 2.0)
- At least 1 measurable unirradiated parenchymal brain metastasis within 21 days prior to study entry; patients who are to undergo SRS must have no more than 10 brain metastases; there is no limit on number of brain metastases for WBRT; the minimum size as measured on T1-weighted gadolinium-enhanced MRI must be as follows according to the number of brain metastases:
- For a single solitary lesion the size must be \>= 10 mm
- For 2 or more lesions, the size of at least 2 of the lesions must be \>= 5 mm
- Patients may also have the following provided the size requirements above are met:
- Progressive parenchymal brain metastasis following stereotactic radiosurgery for 1-3 brain metastases, with at least 1 new measurable brain lesion
- Progressive parenchymal brain metastasis following surgical resection of 1-3 brain metastases, with at least 1 measurable brain lesion
- History/physical examination within 21 days prior to study entry
- Karnofsky performance status \>= 60 within 21 days prior to study entry
- Able to swallow and retain oral medication (note: for patients unable to swallow tablets, an oral suspension preparation is acceptable)
- Absolute neutrophil count (ANC) \>= 1,200 cells/mm\^3 (within 21 days prior to study entry)
- Platelets \>= 70,000 cells/mm\^3 (within 21 days prior to study entry)
- Hemoglobin \>= 8.0 g/dL (note: the use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 8.0 g/dL is acceptable) (within 21 days prior to study entry)
- Creatinine \< 1.5 times institutional upper limit of normal (within 21 days prior to study entry)
- +6 more criteria
You may not qualify if:
- Prior WBRT
- Prior radiation therapy (RT) (any site) with concurrent lapatinib defined as 1 or more days on which the patient received both radiation therapy and lapatinib on the same day
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Prior invasive malignancy (except non-melanomatous skin cancer, curatively resected thyroid papillary carcinoma, and invasive and non-invasive cancers related to the breast cancer) unless disease free for a minimum of 3 years
- Leptomeningeal disease
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields except patients who have progressed following stereotactic radiosurgery for 1-3 brain metastases, with at least one new lesion
- Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study entry
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; hepatic or biliary disease that is acute or currently active or that requires antiviral therapy (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment)
- History of left ventricular ejection fraction (LVEF) below institutional normal unless repeated and within institutional normal range within 90 days of study entry
- Grade 2 or greater rash of any cause at time of study entry
- Grade 2 or greater diarrhea of any cause at time of study entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)lead
- NRG Oncologycollaborator
Study Sites (302)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
The Kirklin Clinic at Acton Road
Birmingham, Alabama, 35243, United States
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, 36688, United States
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
Sutter Auburn Faith Hospital
Auburn, California, 95602, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704, United States
Mills-Peninsula Medical Center
Burlingame, California, 94010, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, 95682, United States
Mercy San Juan Medical Center
Carmichael, California, 95608, United States
Sutter Davis Hospital
Davis, California, 95616, United States
Epic Care-Dublin
Dublin, California, 94568, United States
Bay Area Breast Surgeons Inc
Emeryville, California, 94608, United States
Epic Care Partners in Cancer Care
Emeryville, California, 94608, United States
Contra Costa Regional Medical Center
Martinez, California, 94553-3156, United States
Memorial Medical Center
Modesto, California, 95355, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, 94040, United States
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, 94040, United States
Sutter Cancer Research Consortium
Novato, California, 94945, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, 94609, United States
Bay Area Tumor Institute
Oakland, California, 94609, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, 94301, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661, United States
Sutter Roseville Medical Center
Roseville, California, 95661, United States
Sutter Medical Center Sacramento
Sacramento, California, 95816, United States
Mercy General Hospital Radiation Oncology Center
Sacramento, California, 95819, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, 94115, United States
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, 95065, United States
Sutter Pacific Medical Foundation
Santa Rosa, California, 95403, United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, 94086, United States
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California, 95687, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, 94589, United States
Epic Care Cyberknife Center
Walnut Creek, California, 94597, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
Christiana Gynecologic Oncology LLC
Newark, Delaware, 19713, United States
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, 19713, United States
Helen F Graham Cancer Center
Newark, Delaware, 19713, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
Beebe Health Campus
Rehoboth Beach, Delaware, 19971, United States
TidalHealth Nanticoke / Allen Cancer Center
Seaford, Delaware, 19973, United States
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, 19801, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Miami Cancer Institute
Miami, Florida, 33176, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Northside Hospital-Forsyth
Cumming, Georgia, 30041, United States
Piedmont Fayette Hospital
Fayetteville, Georgia, 30214, United States
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, 30501, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605, United States
Idaho Urologic Institute-Meridian
Meridian, Idaho, 83642, United States
Rush - Copley Medical Center
Aurora, Illinois, 60504, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612, United States
UChicago Medicine Comprehensive Cancer Center - Saint Joseph Hospital
Chicago, Illinois, 60657, United States
Carle on Vermilion
Danville, Illinois, 61832, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Elkhart Clinic
Elkhart, Indiana, 46514-2098, United States
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, 46514, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Radiation Oncology Associates PC
Fort Wayne, Indiana, 46804, United States
Parkview Hospital Randallia
Fort Wayne, Indiana, 46805, United States
Parkview Regional Medical Center
Fort Wayne, Indiana, 46845, United States
Community Howard Regional Health
Kokomo, Indiana, 46904, United States
IU Health La Porte Hospital
La Porte, Indiana, 46350, United States
Memorial Regional Cancer Center Day Road
Mishawaka, Indiana, 46545, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, 46545, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, 46545, United States
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, 46563, United States
Reid Health
Richmond, Indiana, 47374, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, 46601, United States
South Bend Clinic
South Bend, Indiana, 46617, United States
Michiana Hematology Oncology PC-Westville
Westville, Indiana, 46391, United States
Saint Luke's Hospital
Cedar Rapids, Iowa, 52402, United States
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846, United States
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530, United States
Kansas Institute of Medicine Cancer and Blood Center
Lenexa, Kansas, 66219, United States
Minimally Invasive Surgery Hospital
Lenexa, Kansas, 66219, United States
Menorah Medical Center
Overland Park, Kansas, 66209, United States
Saint Luke's South Hospital
Overland Park, Kansas, 66213, United States
Norton Hospital Pavilion and Medical Campus
Louisville, Kentucky, 40202, United States
Norton Suburban Hospital and Medical Campus
Louisville, Kentucky, 40207, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Bixby Medical Center
Adrian, Michigan, 49221, United States
Hickman Cancer Center
Adrian, Michigan, 49221, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, 49307, United States
Saint Joseph Mercy Brighton
Brighton, Michigan, 48114, United States
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183, United States
Saint Joseph Mercy Canton
Canton, Michigan, 48188, United States
Saint Joseph Mercy Chelsea
Chelsea, Michigan, 48118, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038, United States
Beaumont Hospital - Dearborn
Dearborn, Michigan, 48124, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Ascension Saint John Hospital
Detroit, Michigan, 48236, United States
Green Bay Oncology - Escanaba
Escanaba, Michigan, 49829, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, 49801, United States
Allegiance Health
Jackson, Michigan, 49201, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Borgess Medical Center
Kalamazoo, Michigan, 49048, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154, United States
Mercy Memorial Hospital
Monroe, Michigan, 48162, United States
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan, 48162, United States
Mercy Health Mercy Campus
Muskegon, Michigan, 49444, United States
Lakeland Hospital Niles
Niles, Michigan, 49120, United States
21st Century Oncology-Pontiac
Pontiac, Michigan, 48341, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
Lake Huron Medical Center
Port Huron, Michigan, 48060, United States
Ascension Saint Mary's Hospital
Saginaw, Michigan, 48601, United States
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, 49085, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322, United States
Metro Health Hospital
Wyoming, Michigan, 49519, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Health Partners Inc
Minneapolis, Minnesota, 55454, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Singing River Hospital
Pascagoula, Mississippi, 39581, United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
Centerpoint Medical Center LLC
Independence, Missouri, 64057, United States
Mercy Hospital Joplin
Joplin, Missouri, 64804, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
North Kansas City Hospital
Kansas City, Missouri, 64116, United States
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, 64118, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, 64086, United States
Liberty Radiation Oncology Center
Liberty, Missouri, 64068, United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, 65401, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
Saint Joseph Oncology Inc
Saint Joseph, Missouri, 64507, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, 63109, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Saint Louis-Cape Girardeau CCOP
St Louis, Missouri, 63141, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Elliot Hospital
Manchester, New Hampshire, 03103, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Virtua Memorial
Mount Holly, New Jersey, 08060, United States
Virtua Voorhees
Voorhees Township, New Jersey, 08043, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102, United States
Memorial Medical Center - Las Cruces
Las Cruces, New Mexico, 88011, United States
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, 11215, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, 13057, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Highland Hospital
Rochester, New York, 14620, United States
University of Rochester
Rochester, New York, 14642, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
AdventHealth Hendersonville
Hendersonville, North Carolina, 28792, United States
Iredell Memorial Hospital
Statesville, North Carolina, 28677, United States
Summa Health System - Akron Campus
Akron, Ohio, 44304, United States
Cleveland Clinic Akron General
Akron, Ohio, 44307, United States
Radiation Oncology Center
Alliance, Ohio, 44601, United States
Summa Health System - Barberton Campus
Barberton, Ohio, 44203, United States
Cleveland Clinic Cancer Center Beachwood
Beachwood, Ohio, 44122, United States
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122, United States
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, 43402, United States
Cleveland Clinic Mercy Hospital
Canton, Ohio, 44708, United States
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
Geauga Hospital
Chardon, Ohio, 44024, United States
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Mercy Cancer Center-Elyria
Elyria, Ohio, 44035, United States
Armes Family Cancer Center
Findlay, Ohio, 45840, United States
Blanchard Valley Hospital
Findlay, Ohio, 45840, United States
Orion Cancer Care
Findlay, Ohio, 45840, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005, United States
Dayton Physicians LLC-Wayne
Greenville, Ohio, 45331, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Cleveland Clinic Cancer Center Independence
Independence, Ohio, 44131, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Lima Memorial Hospital
Lima, Ohio, 45804, United States
Cleveland Clinic Cancer Center Mansfield
Mansfield, Ohio, 44906, United States
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, 43537, United States
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, 43537, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124, United States
Summa Health Medina Medical Center
Medina, Ohio, 44256, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, 44060, United States
UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights, Ohio, 44130, United States
Saint Charles Hospital
Oregon, Ohio, 43616, United States
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, 43616, United States
University Hospitals Parma Medical Center
Parma, Ohio, 44129, United States
University Hospitals Portage Medical Center
Ravenna, Ohio, 44266, United States
UH Seidman Cancer Center at Salem Regional Medical Center
Salem, Ohio, 44460, United States
North Coast Cancer Care
Sandusky, Ohio, 44870, United States
Springfield Regional Cancer Center
Springfield, Ohio, 45504, United States
Springfield Regional Medical Center
Springfield, Ohio, 45505, United States
Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio, 44136, United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, 44883, United States
Saint Vincent Mercy Medical Center
Toledo, Ohio, 43608, United States
University of Toledo
Toledo, Ohio, 43614, United States
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, 43617, United States
Mercy Health - Saint Anne Hospital
Toledo, Ohio, 43623, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, 43623, United States
Dayton Physicians LLC-Upper Valley
Troy, Ohio, 45373, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Fulton County Health Center
Wauseon, Ohio, 43567, United States
UHHS-Westlake Medical Center
Westlake, Ohio, 44145, United States
Cancer Treatment Center
Wooster, Ohio, 44691, United States
Cleveland Clinic Wooster Family Health and Surgery Center
Wooster, Ohio, 44691, United States
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, Oklahoma, 74136, United States
Warren Clinic Oncology-Tulsa
Tulsa, Oklahoma, 74146, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210, United States
Jefferson Abington Hospital
Abington, Pennsylvania, 19001, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017, United States
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
AnMed Health Cancer Center
Anderson, South Carolina, 29621, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Covenant Medical Center-Lakeside
Lubbock, Texas, 79410, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
University of Vermont and State Agricultural College
Burlington, Vermont, 05405, United States
Fredericksburg Oncology Inc
Fredericksburg, Virginia, 22401, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
Legacy Salmon Creek Hospital
Vancouver, Washington, 98686, United States
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia, 26003, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, 54301-3526, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, 54303, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303, United States
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin, 53038, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, 54221, United States
Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Ascension Columbia Saint Mary's Hospital Ozaukee
Mequon, Wisconsin, 53097, United States
Ascension Columbia Saint Mary's Hospital - Milwaukee
Milwaukee, Wisconsin, 53211, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495, United States
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235, United States
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Keimyung University-Dongsan Medical Center
Dalseo-gu, Daegu, 42601, South Korea
National Cancer Center-Korea
Goyang-si, Gyeonggi-do, 410-769, South Korea
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, 519-763, South Korea
Samsung Medical Center
Seoul, Korea, 135-710, South Korea
Seoul National University Bundang Hospital
Seongnam, Kyeonggi-do, 463-707, South Korea
Gangnam Severance Hospital
Seoul, 06273, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Yonsei University Health System-Severance Hospital
Seoul, 120-752, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Wendy Seiferheld
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
In A Kim
NRG Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2012
First Posted
June 19, 2012
Study Start
December 6, 2012
Primary Completion
December 30, 2019
Study Completion
May 20, 2022
Last Updated
October 17, 2023
Results First Posted
April 13, 2021
Record last verified: 2023-09