Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine) to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Methylated Glioblastoma
A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients With Methylated MGMT Promoter Glioblastoma
3 other identifiers
interventional
265
2 countries
420
Brief Summary
This phase III trial compares the effect of adding lomustine to standard chemotherapy with temozolomide and radiation therapy versus temozolomide and radiation therapy alone in shrinking or stabilizing newly diagnosed MGMT methylated glioblastoma. MGMT methylated tumors are more likely to respond to temozolomide chemotherapy. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells and slow down or stop tumor growth. Lomustine is a chemotherapy drug and in a class of medications called alkylating agents. It damages the cell's DNA and may kill tumor cells. Radiation therapy uses high energy x-ray photons to kill tumor cells and shrink tumors. Adding lomustine to standard chemotherapy with temozolomide and radiation therapy may shrink or stabilize glioblastoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2022
Typical duration for phase_3
420 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
October 15, 2021
CompletedFirst Posted
Study publicly available on registry
October 27, 2021
CompletedStudy Start
First participant enrolled
March 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 8, 2026
May 6, 2026
April 1, 2026
4.4 years
October 15, 2021
May 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival
The Kaplan-Meier method will be used to estimate survival distribution for each treatment arm.
From randomization to death due to any cause, assessed up to 5 years from randomization
Secondary Outcomes (3)
Progression free survival (PFS)
From randomization to disease progression or death due to any cause, whichever occurs first, assessed up to 5 years from randomization
Incidence of adverse events
Up to 5 years from randomization
Patient reported outcomes
Up to 5 years from randomization
Other Outcomes (5)
Absolute lymphocyte counts
Up to 5 years from randomization
CD4+ lymphocyte counts
Up to 5 years from randomization
Estimation of the primary outcome treatment effect by sex
Up to 5 years from randomization
- +2 more other outcomes
Study Arms (2)
Arm I (radiation therapy, temozolomide)
ACTIVE COMPARATORPatients undergo radiation therapy 5 days per week and receive temozolomide PO QD for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive temozolomide PO QD on days 1-5 of each cycle. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI throughout the trial.
ARM II (radiation therapy, temozolomide, lomustine)
EXPERIMENTALPatients undergo radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive lomustine PO on day 1 of each cycle and temozolomide PO QD on days 2-6 of each cycle. Treatment repeats every 42 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI throughout the trial.
Interventions
Undergo radiation therapy
Given PO
Undergo MRI
Ancillary studies
Given PO
Eligibility Criteria
You may qualify if:
- STEP 1 REGISTRATION: No known IDH mutation. (If tested before step 1 registration, patients known to have IDH mutation in the tumor on local or other testing are ineligible and should not be registered)
- STEP 1 REGISTRATION: Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block and hematoxylin and eosin (H\&E) stained slide to be sent for central pathology review for confirmation of histology and MGMT promoter methylation status. Note that tissue for central pathology review and central MGMT assessment must be received by the New York University (NYU) Center for Biospecimen Research and Development (CBRD) on or before postoperative calendar day 30. If tissue cannot be received by postoperative calendar day 30, then patients may NOT enroll on this trial as central pathology review will not be complete in time for the patient to start treatment no later than 8 weeks following surgery. Results of central pathology review and central MGMT analysis will generally be completed within 10 business days of receipt of tissue. Results will be entered by the central lab directly into Rave. Note: In the event of an additional tumor resection(s), tissue must be received within 30 days of the most recent resection and the latest resection must have been performed within 30 days after the initial resection. Surgical resection is required; stereotactic biopsy alone is not allowed because it will not provide sufficient tissue for MGMT analysis
- STEP 1 REGISTRATION: The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
- STEP 2 REGISTRATION: Histopathologically proven diagnosis of glioblastoma (or gliosarcoma as a subtype of glioblastoma) confirmed by central pathology review
- STEP 2 REGISTRATION: MGMT promoter with methylation confirmed by central pathology review. Note: Patients with tissue that is insufficient or inadequate for analysis, fails MGMT testing, or has indeterminate or unmethylated MGMT promoter are excluded
- Note: Any MGMT result other than methylated would require step 2 registration to be reported as a "central review failure"
- STEP 2 REGISTRATION: Contrast-enhanced brain MRI performed either after surgery or prior to step 2 registration
- STEP 2 REGISTRATION: IDH mutation testing by at least one method (such as immunohistochemistry for IDH1 R132H) must be performed as part of standard of care and no mutation must be found (i.e IDH wildtype). (If a mutation is identified then the patient will be ineligible and must be registered as ineligible at step 2.)
- STEP 2 REGISTRATION: History/physical examination within 28 days prior to step 2 registration
- STEP 2 REGISTRATION: Karnofsky performance status (KPS) \>= 70 within 28 days prior to step 2 registration
- STEP 2 REGISTRATION: Neurologic function assessment within 28 days prior to step 2 registration
- STEP 2 REGISTRATION: Age 18-70 years
- STEP 2 REGISTRATION: Hemoglobin \>= 10 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 10.0 g/dl is acceptable) (Within 14 days prior to step 2 registration)
- STEP 2 REGISTRATION: Leukocytes \>= 2,000/mm\^3 (Within 14 days prior to step 2 registration)
- STEP 2 REGISTRATION: Absolute neutrophil count \>= 1,500/mm\^3 (Within 14 days prior to step 2 registration)
- +12 more criteria
You may not qualify if:
- STEP 2 REGISTRATION: Prior therapy for tumor except for resection or prior laser interstitial thermal therapy (LITT). For example, prior chemotherapy, immunotherapy, or targeted therapy for GBM or lower grade glioma is disallowed (including but not limited to temozolomide, lomustine, bevacizumab, any viral therapy, ipilimumab or other CTLA-4 antibody, PD-1 antibody, CD-137 agonist, CD40 antibody, PDL-1 or 2 antibody, vaccine therapy, polio or similar viral injection as treatment for the tumor, and/or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) as is Gliadel wafer, radiotherapy, radiosurgery, vaccine or other immunotherapy, brachytherapy, or convection enhanced delivery
- STEP 2 REGISTRATION: Current or planned treatment with any other investigational agents for the study cancer
- STEP 2 REGISTRATION: Definitive clinical or radiologic evidence of metastatic disease outside the brain
- STEP 2 REGISTRATION: Prior invasive malignancy (except non-melanomatous skin cancer, cervical cancer in situ and melanoma in situ) unless disease free for a minimum of 2 years
- STEP 2 REGISTRATION: Prior radiotherapy to the head or neck that would result in overlap of radiation therapy fields
- STEP 2 REGISTRATION: Pregnancy and individuals unwilling to discontinue nursing due to the potential teratogenic effects and potential risk for adverse events in nursing infants
- STEP 2 REGISTRATION: History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or lomustine
- STEP 2 REGISTRATION: History of pulmonary fibrosis
- STEP 2 REGISTRATION: Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection requiring intravenous (IV) antibiotics, IV antiviral, or IV antifungal treatment
- Symptomatic congestive heart failure, defined as New York Heart Association Functional Classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification)
- Unstable angina pectoris within 6 months prior to Step 2 registration
- Uncontrolled cardiac arrhythmia
- Psychiatric illness/social situations that would limit compliance with study requirements
- STEP 2 REGISTRATION: Evidence of diffuse leptomeningeal disease that requires whole brain irradiation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NRG Oncologylead
- National Cancer Institute (NCI)collaborator
Study Sites (420)
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701, United States
Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas, 72703, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Highlands Oncology Group - Rogers
Rogers, Arkansas, 72758, United States
Highlands Oncology Group
Springdale, Arkansas, 72762, United States
Kaiser Permanente-Anaheim
Anaheim, California, 92806, United States
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531, United States
Sutter Auburn Faith Hospital
Auburn, California, 95602, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603, United States
Kaiser Permanente-Bellflower
Bellflower, California, 90706, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704, United States
Mercy Cancer Center - Carmichael
Carmichael, California, 95608, United States
Mercy San Juan Medical Center
Carmichael, California, 95608, United States
John Muir Medical Center-Concord
Concord, California, 94520, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
Kaiser Permanente Dublin
Dublin, California, 94568, United States
Mercy Cancer Center - Elk Grove
Elk Grove, California, 95758, United States
Kaiser Permanente-Fremont
Fremont, California, 94538, United States
Palo Alto Medical Foundation-Fremont
Fremont, California, 94538, United States
Fresno Cancer Center
Fresno, California, 93720, United States
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, 93720, United States
Kaiser Permanente-Fresno
Fresno, California, 93720, United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Kaiser Permanente- Modesto MOB II
Modesto, California, 95356, United States
Kaiser Permanente-Modesto
Modesto, California, 95356, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, 94040, United States
Kaiser Permanente Oakland-Broadway
Oakland, California, 94611, United States
Kaiser Permanente-Oakland
Oakland, California, 94611, United States
Kaiser Permanente-Ontario
Ontario, California, 91761, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, 94301, United States
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, 95670, United States
Kaiser Permanente- Marshall Medical Offices
Redwood City, California, 94063, United States
Kaiser Permanente-Richmond
Richmond, California, 94801, United States
Mercy Cancer Center - Rocklin
Rocklin, California, 95765, United States
Rohnert Park Cancer Center
Rohnert Park, California, 94928, United States
Kaiser Permanente-Roseville
Roseville, California, 95661, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661, United States
Sutter Roseville Medical Center
Roseville, California, 95661, United States
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, 95678, United States
Kaiser Permanente Downtown Commons
Sacramento, California, 95814, United States
Mercy Cancer Center - Sacramento
Sacramento, California, 95816, United States
Sutter Medical Center Sacramento
Sacramento, California, 95816, United States
Kaiser Permanente-South Sacramento
Sacramento, California, 95823, United States
South Sacramento Cancer Center
Sacramento, California, 95823, United States
Kaiser Permanente-San Diego Zion
San Diego, California, 92120, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, 94115, United States
Kaiser Permanente-San Francisco
San Francisco, California, 94115, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, 95119, United States
Kaiser Permanente San Leandro
San Leandro, California, 94577, United States
Kaiser San Rafael-Gallinas
San Rafael, California, 94903, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403, United States
Sutter Pacific Medical Foundation
Santa Rosa, California, 95403, United States
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, 94080, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080, United States
Kaiser Permanente-Stockton
Stockton, California, 95210, United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, 94086, United States
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, 95688, United States
Kaiser Permanente-Vallejo
Vallejo, California, 94589, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596, United States
John Muir Medical Center-Walnut Creek
Walnut Creek, California, 94598, United States
Woodland Memorial Hospital
Woodland, California, 95695, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909, United States
Memorial Hospital North
Colorado Springs, Colorado, 80920, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, 80528, United States
Lutheran Hospital - Cancer Centers of Colorado
Golden, Colorado, 80401, United States
UCHealth Greeley Hospital
Greeley, Colorado, 80631, United States
AdventHealth Littleton
Littleton, Colorado, 80122, United States
Medical Center of the Rockies
Loveland, Colorado, 80538, United States
AdventHealth Parker
Parker, Colorado, 80138, United States
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830, United States
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, 06510, United States
Yale University
New Haven, Connecticut, 06520, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611, United States
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, 06385, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
Miami Cancer Institute
Miami, Florida, 33176, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Augusta University Medical Center
Augusta, Georgia, 30912, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, 83301, United States
Alton Memorial Hospital
Alton, Illinois, 62002, United States
Rush-Copley Medical Center
Aurora, Illinois, 60504, United States
Advocate Outpatient Center - Aurora
Aurora, Illinois, 60506, United States
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Centralia Oncology Clinic
Centralia, Illinois, 62801, United States
Rush MD Anderson Cancer Center
Chicago, Illinois, 60612, United States
University of Illinois
Chicago, Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657, United States
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014, United States
Carle at The Riverfront
Danville, Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Advocate Sherman Hospital
Elgin, Illinois, 60123, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
AMG Libertyville - Oncology
Libertyville, Illinois, 60048, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699, United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
Memorial Hospital East
Shiloh, Illinois, 62269, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Springfield Memorial Hospital
Springfield, Illinois, 62781, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
The Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Illinois CancerCare - Washington
Washington, Illinois, 61571, United States
Midwestern Regional Medical Center
Zion, Illinois, 60099, United States
Northwest Cancer Center - Main Campus
Crown Point, Indiana, 46307, United States
UChicago Medicine Northwest Indiana
Crown Point, Indiana, 46307, United States
Northwest Oncology LLC
Dyer, Indiana, 46311, United States
Northwest Cancer Center - Hobart
Hobart, Indiana, 46342, United States
Saint Mary Medical Center
Hobart, Indiana, 46342, United States
Community Cancer Center East
Indianapolis, Indiana, 46219, United States
Community Cancer Center South
Indianapolis, Indiana, 46227, United States
Community Cancer Center North
Indianapolis, Indiana, 46256, United States
The Community Hospital
Munster, Indiana, 46321, United States
Women's Diagnostic Center - Munster
Munster, Indiana, 46321, United States
Northwest Cancer Center - Valparaiso
Valparaiso, Indiana, 46383, United States
Mary Greeley Medical Center
Ames, Iowa, 50010, United States
McFarland Clinic - Ames
Ames, Iowa, 50010, United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023, United States
Mercy Hospital
Cedar Rapids, Iowa, 52403, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325, United States
Greater Regional Medical Center
Creston, Iowa, 50801, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309, United States
Broadlawns Medical Center
Des Moines, Iowa, 50314, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101, United States
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, 50263, United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266, United States
The Iowa Clinic PC
West Des Moines, Iowa, 50266, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210, United States
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, 66211, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205, United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202, United States
Norton Brownsboro Hospital and Medical Campus
Louisville, Kentucky, 40241, United States
UofL Health Medical Center Northeast
Louisville, Kentucky, 40245, United States
Lafayette Family Cancer Center-EMMC
Brewer, Maine, 04412, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland, 21044, United States
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061, United States
UM Capital Region Medical Center
Largo, Maryland, 20774, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114, United States
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188, United States
Trinity Health Medical Center - Canton
Canton, Michigan, 48188, United States
Caro Cancer Center
Caro, Michigan, 48723, United States
Chelsea Hospital
Chelsea, Michigan, 48118, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118, United States
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503, United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503, United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503, United States
Henry Ford Saint John Hospital - Van Elslander
Grosse Pointe Woods, Michigan, 48236, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Beacon Kalamazoo
Kalamazoo, Michigan, 49048, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154, United States
Henry Ford Saint John Hospital - Macomb Medical
Macomb, Michigan, 48044, United States
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan, 48453, United States
Michigan Healthcare Professionals Pontiac
Pontiac, Michigan, 48341, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341, United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan, 48601, United States
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, 48604, United States
MyMichigan Medical Center Tawas
Tawas City, Michigan, 48764, United States
Henry Ford Health Warren Hospital
Warren, Michigan, 48093, United States
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan, 48661, United States
University of Michigan Health - West
Wyoming, Michigan, 49519, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636, United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805, United States
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805, United States
Miller-Dwan Hospital
Duluth, Minnesota, 55805, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746, 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
Avera Cancer Institute at Marshall
Marshall, Minnesota, 56258, 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
Monticello Cancer Center
Monticello, Minnesota, 55362, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303, 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
Essentia Health Sandstone
Sandstone, Minnesota, 55072, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, 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
Parkland Health Center - Farmington
Farmington, Missouri, 63640, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154, United States
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064, United States
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri, 64116, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080, United States
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756, United States
John F Kennedy Medical Center
Edison, New Jersey, 08818, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631, United States
Jersey City Medical Center
Jersey City, New Jersey, 07302, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Monmouth Medical Center
Long Branch, New Jersey, 07740, United States
Jersey Shore Medical Center
Neptune City, New Jersey, 07753, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07101, United States
Community Medical Center
Toms River, New Jersey, 08755, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
Sands Cancer Center
Canandiaqua, New York, 14424, United States
Noyes Memorial Hospital/Myers Cancer Center
Dansville, New York, 14437, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
University of Rochester
Rochester, New York, 14642, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Cleveland Clinic Akron General
Akron, Ohio, 44307, United States
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431, United States
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220, United States
Bethesda North Hospital
Cincinnati, Ohio, 45242, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Premier Blood and Cancer Center
Dayton, Ohio, 45409, United States
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415, United States
Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Dublin Methodist Hospital
Dublin, Ohio, 43016, 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
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560, United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, 43606, United States
Dayton Physicians LLC - Troy
Troy, Ohio, 45373, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146, United States
Saint Charles Health System
Bend, Oregon, 97701, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030, United States
Providence Newberg Medical Center
Newberg, Oregon, 97132, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Kaiser Permanente Northwest
Portland, Oregon, 97227, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, 97062, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103, United States
UPMC Altoona
Altoona, Pennsylvania, 16601, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505, United States
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania, 16121, United States
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601, United States
UPMC Hillman Cancer Center in Greenville/UPMC Horizon
Greenville, Pennsylvania, 16125, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Jefferson Hospital
Jefferson Hills, Pennsylvania, 15025, United States
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, 15901, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837, United States
Forbes Hospital
Monroeville, Pennsylvania, 15146, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232, United States
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, 15237, United States
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, 17901, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania, 15090, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Roper Hospital
Charleston, South Carolina, 29401, United States
Charleston Oncology - Roper
Charleston, South Carolina, 29403, United States
Bon Secours Saint Francis Hospital
Charleston, South Carolina, 29414, United States
Charleston Oncology - Saint Francis
Charleston, South Carolina, 29414, United States
Avera Cancer Institute at Pierre
Pierre, South Dakota, 57501, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Avera Cancer Institute at Yankton
Yankton, South Dakota, 57078, United States
Parkland Memorial Hospital
Dallas, Texas, 75235, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030, United States
Ben Taub General Hospital
Houston, Texas, 77030, United States
Memorial Hermann Texas Medical Center
Houston, Texas, 77030, United States
Memorial Hermann Northeast Hospital
Humble, Texas, 77338, United States
Memorial Hermann The Woodlands Hospital
The Woodlands, Texas, 77380, United States
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah, 84003, United States
Sandra L Maxwell Cancer Center
Cedar City, Utah, 84720, United States
Logan Regional Hospital
Logan, Utah, 84321, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
Utah Valley Regional Medical Center
Provo, Utah, 84604, United States
Riverton Hospital
Riverton, Utah, 84065, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Saint George Regional Medical Center
St. George, Utah, 84770, 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
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, 05819, United States
Inova Alexandria Hospital
Alexandria, Virginia, 22304, United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031, United States
Inova Fair Oaks Hospital
Fairfax, Virginia, 22033, United States
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, 23116, United States
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114, United States
Bon Secours Saint Mary's Hospital
Richmond, Virginia, 23226, United States
Henrico Doctor's Hospital
Richmond, Virginia, 23229, United States
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia, 23230, United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver, Washington, 98684, United States
Legacy Salmon Creek Hospital
Vancouver, Washington, 98686, United States
West Virginia University Healthcare
Morgantown, West Virginia, 26506, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409, United States
Duluth Clinic Ashland
Ashland, Wisconsin, 54806, United States
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, 54806, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105, United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Essentia Health-Hayward Clinic
Hayward, Wisconsin, 54843, United States
University of Wisconsin Carbone Cancer Center - Johnson Creek
Johnson Creek, Wisconsin, 53038, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143, United States
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233, United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406, United States
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, 54501, United States
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, 53081, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081, United States
Essentia Health-Spooner Clinic
Spooner, Wisconsin, 54801, United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495, United States
Aurora Medical Center in Summit
Summit, Wisconsin, 53066, United States
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin, 54880, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494, United States
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4, Canada
The Research Institute of the McGill University Health Centre (MUHC)
Montreal, Quebec, H3H 2R9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fabio M Iwamoto
NRG Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2021
First Posted
October 27, 2021
Study Start
March 28, 2022
Primary Completion (Estimated)
August 8, 2026
Study Completion (Estimated)
August 8, 2026
Last Updated
May 6, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.