Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery
Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma
3 other identifiers
interventional
162
5 countries
215
Brief Summary
This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2017
Longer than P75 for phase_3
215 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 6, 2017
CompletedFirst Posted
Study publicly available on registry
June 8, 2017
CompletedStudy Start
First participant enrolled
September 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 15, 2032
October 2, 2026
September 1, 2026
9.8 years
June 6, 2017
September 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression free survival (PFS)
Kaplan-Meier method will be used to calculate the PFS rates for each of the two arms. Hazard ratio (HR) on the treatment effect will be calculated using the Cox proportional hazard model. A one-sided log-rank test will be used to test the difference in PFS between the two arms.
From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed up to 10 years
Secondary Outcomes (14)
PFS
From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed at 3 years
PFS
From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed up to 5 years
Disease-specific survival (DSS)
From randomization to disease-related death, assessed up to 10 years
DSS rates
At 3 years
DSS rates
At 5 years
- +9 more secondary outcomes
Study Arms (2)
Arm I (observation)
ACTIVE COMPARATORPatients undergo observation. Additionally, patients undergo MRI and blood collection throughout the study.
Arm II (radiation therapy)
EXPERIMENTALPatients undergo IMRT or proton beam radiation therapy 5 days a week over 6.5-7 weeks for a total of 33 fractions in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and blood collection throughout the study.
Interventions
Undergo IMRT
Undergo proton beam radiation therapy
Ancillary studies
Undergo MRI
Undergo collection of blood samples
Eligibility Criteria
You may qualify if:
- PRIOR TO STEP 1 REGISTRATION:
- The patient must have a newly diagnosed unifocal intracranial meningioma, gross totally resected, and histologically confirmed as WHO grade II based upon pathology findings at the enrolling institution. WHO grade will be assigned according to WHO 2016 criteria
- Gross total resection (GTR) will be interpreted as modified Simpson grade 1-3 without gross residual dural-based or extradural tumor. GTR must be confirmed both by modified Simpson grade and by post-operative magnetic resonance imaging (MRI) findings. The modified Simpson grade can be inferred from the operative report (surgeon does not need to explicitly describe the Simpson grade for the purposes of eligibility)
- Step 1 registration must occur within 180 days of the initial surgery; this will provide sufficient time for post-operative imaging confirmation of resection extent after resolution of operative changes. Moreover, it will permit additional surgery if needed to achieve a GTR. Within this 180 day interval, a second surgery is permitted in order to achieve GTR, but even with a second surgery, Step 1 registration must occur within 180 days of the initial resection
- GTR must be confirmed on post-operative imaging following the most recent surgery. For protocol enrollment, the assessment of GTR will be made at each site. However, submission of both pre-operative and post-operative MRIs is required for patients. If a second surgery is performed, submission of post-operative MRI is required and pre-operative MRI is required only if obtained. All sequences obtained in the pre- and post-operative MR imaging are to be submitted to National Radiology Group (NRG) Oncology for study registration. The post-operative MRI must be completed within sufficient time to permit step 1 registration within 180 days of the initial resection. These same conditions apply in the setting of a second surgical procedure, although if a second surgery is completed, step 1 registration must still occur with 180 days of initial surgery. Computed tomography (CT) imaging is not required, but may be obtained if desired clinically, for instance to assess calcifications or hyperostosis
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
- NOTE: Central pathology review must occur between steps 1 and 2 of registration. Once appropriate pathology specimens are received, central pathology review will occur within 10 business days, and must confirm WHO grade II meningioma before the patient can proceed to step 2 registration and randomization
- PRIOR TO STEP 2 REGISTRATION:
- Histologically confirmed diagnosis of WHO grade II meningioma confirmed by central pathology review prior to step 2 registration
- Age \>= 18
- History/physical examination, including neurologic examination within 60 days prior to step 2 registration
- Post-operative Zubrod performance status 0-1 within 60 days prior to step 2 registration
- If the patient is a woman is of childbearing potential, a serum pregnancy test, obtained within 14 days prior to step 2 registration, must be negative, and, if randomized to receive radiation therapy, the woman must agree to use contraception
You may not qualify if:
- Optic nerve sheath meningioma, spinal or other extracranial meningioma, multiple meningiomas, hemangiopericytoma
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (carcinoma in situ of the breast, oral cavity, cervix, melanoma in situ, or other non-invasive malignancies are permissible)
- Previous radiotherapy to the scalp, cranium, brain, or skull base and radiation-induced meningiomas
- Major medical illnesses or psychiatric impairments, which in the investigators opinion, will prevent administration or completion of the protocol therapy and/or preclude informed consent; these include, but are not restricted to:
- Unstable angina and/or congestive heart failure requiring hospitalization at the time of step 2 registration
- Transmural myocardial infarction within the last 6 months prior to step 2 registration
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 2 registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 2 registration
- Type II neurofibromatosis (NF2)
- Ailments entailing substantial increases in sensitivity and side effect risk from radiation therapy (ataxia telangiectasia, Nijmegen breakage syndrome, and human immunodeficiency virus (HIV) with CD4 count \< 200 cells/microliter); HIV testing is not required for eligibility for this protocol, and known HIV positive patients are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count \>= 200 cells/microliter within 30 days prior to step 2 registration
- Inability to undergo MRI with and without contrast (e.g. claustrophobia, non-MRI compatible implant or foreign body, gadolinium allergy or renal dysfunction preventing the patient from receiving gadolinium- institutional guidelines should be used to determine if patients are at risk for renal dysfunction). Note that patients with severe claustrophobia are permitted on this study if they are willing and able to undergo MRI with adequate sedation or anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NRG Oncologylead
- National Cancer Institute (NCI)collaborator
Study Sites (215)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona, 85704, United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719, United States
Kaiser Permanente-Anaheim
Anaheim, California, 92806, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603, United States
Kaiser Permanente-Bellflower
Bellflower, California, 90706, United States
Kaiser Permanente Dublin
Dublin, California, 94568, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Los Angeles General Medical Center
Los Angeles, California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Memorial Medical Center
Modesto, California, 95355, United States
Kaiser Permanente Oakland-Broadway
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
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304, United States
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, 95670, United States
Rohnert Park Cancer Center
Rohnert Park, California, 94928, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661, United States
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, 95678, United States
Sutter Medical Center Sacramento
Sacramento, California, 95816, United States
South Sacramento Cancer Center
Sacramento, California, 95823, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, 94115, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051, United States
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, 94080, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, 94589, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Yale University
New Haven, Connecticut, 06520, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611, United States
Helen F Graham Cancer Center
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
Boca Raton Regional Hospital
Boca Raton, Florida, 33486, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442, United States
UM Sylvester Comprehensive Cancer Center at Doral
Doral, Florida, 33166, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, 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
AdventHealth Orlando
Orlando, Florida, 32803, United States
AdventHealth East Orlando
Orlando, Florida, 32822, United States
Memorial Hospital West
Pembroke Pines, Florida, 33028, United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, 33324, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Grady Health System
Atlanta, Georgia, 30303, United States
Emory Proton Therapy Center
Atlanta, Georgia, 30308, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, 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
Piedmont Newnan Hospital
Newnan, Georgia, 30265, United States
Piedmont Henry Hospital
Stockbridge, Georgia, 30281, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush MD Anderson Cancer Center
Chicago, Illinois, 60612, United States
University of Illinois
Chicago, Illinois, 60612, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134, United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, 60026, United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, 60035, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
IU Health Methodist Hospital
Indianapolis, Indiana, 46202, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, 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 Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202, United States
UofL Health Medical Center Northeast
Louisville, Kentucky, 40245, United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103, United States
MaineHealth Coastal Cancer Treatment Center
Bath, Maine, 04530, United States
MaineHealth Maine Medical Center - Portland
Portland, Maine, 04102, United States
MaineHealth Cancer Care Center of York County
Sanford, Maine, 04073, United States
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, 04074, United States
Maryland Proton Treatment Center
Baltimore, Maryland, 21201, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
Chelsea Hospital
Chelsea, Michigan, 48118, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236, United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154, United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan, 48601, United States
Henry Ford Health Warren Hospital
Warren, Michigan, 48093, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322, United States
University of Michigan Health - West
Wyoming, Michigan, 49519, United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805, United States
Miller-Dwan Hospital
Duluth, Minnesota, 55805, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376, United States
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri, 65212, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Logan Health Medical Center
Kalispell, Montana, 59901, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, 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
Capital Health Medical Center-Hopewell
Pennington, New Jersey, 08534, United States
ProCure Proton Therapy Center-Somerset
Somerset, New Jersey, 08873, United States
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, 08876, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, 11215, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
The New York Hospital Medical Center of Queens
Flushing, New York, 11355, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
NYP/Weill Cornell Medical Center
New York, New York, 10065, United States
University of Rochester
Rochester, New York, 14642, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Mercy Cancer Center-Elyria
Elyria, Ohio, 44035, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, 44060, United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560, United States
UHHS-Westlake Medical Center
Westlake, Ohio, 44145, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210, United States
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, 18015, United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837, United States
Lewistown Hospital
Lewistown, Pennsylvania, 17044, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, 17901, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah, 84003, 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
LDS Hospital
Salt Lake City, Utah, 84143, United States
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, 05819, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
University of Washington Medical Center - Montlake
Seattle, Washington, 98195, United States
Legacy Salmon Creek Hospital
Vancouver, Washington, 98686, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701, 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
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548, United States
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868, United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476, United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494, United States
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2, Canada
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
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
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Tata Memorial Hospital
Mumbai, 400 012, India
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Iwate Medical University Hospital
Shiwa-gun, Iwate, 028-3695, Japan
Kyorin University Hospital
Mitaka-shi, Tokyo, 181-8611, Japan
Keio University
Shinjuku-ku, Tokyo, 160-8582, Japan
Hiroshima University Hospital
Hiroshima, 734-8551, Japan
Saitama Medical University International Medical Center
Saitama, 350-1298, Japan
National Cancer Center Hospital
Tokyo, 104 0045, Japan
King Faisal Specialist Hospital and Research Centre
Riyadh, 11211, Saudi Arabia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael A Vogelbaum
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
June 6, 2017
First Posted
June 8, 2017
Study Start
September 12, 2017
Primary Completion (Estimated)
June 15, 2027
Study Completion (Estimated)
June 15, 2032
Last Updated
October 2, 2026
Record last verified: 2026-09
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.