Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma
Randomized Phase II Trial of Hypofractionated Dose-Escalated Photon IMRT or Proton Beam Therapy Versus Conventional Photon Irradiation With Concomitant and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma
4 other identifiers
interventional
624
2 countries
237
Brief Summary
This randomized phase II trial studies how well dose-escalated photon intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy works compared with standard-dose radiation therapy when given with temozolomide in patients with newly diagnosed glioblastoma. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as temozolomide, may make tumor cells more sensitive to radiation therapy. It is not yet known whether dose-escalated photon IMRT or proton beam radiation therapy is more effective than standard-dose radiation therapy with temozolomide in treating glioblastoma.
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 2014
Longer than P75 for phase_2
237 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 27, 2014
CompletedFirst Posted
Study publicly available on registry
July 1, 2014
CompletedStudy Start
First participant enrolled
December 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2025
CompletedResults Posted
Study results publicly available
August 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2030
ExpectedOctober 1, 2026
September 1, 2026
10.6 years
June 27, 2014
June 22, 2026
September 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Median Survival Time (Within Center Group)
Comparisons occur between standard vs. intensified RT arms within group (Group 1: photon IMRT centers; Group 2: proton centers). Median survival times were estimated using the Kaplan-Meier method, censoring participants alive at the time of analysis. Comparisons occur between standard vs. intensified RT arms within group (Group 1: photon IMRT centers; Group 2: proton centers)
Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
Secondary Outcomes (7)
Median Survival Time (Between Experimental Arms)
Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
Median Progression-free Survival Time
Randomization to progression, death, or last follow-up, whichever occurs first. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
Proportion of Participants With a Grade 3 or Higher Adverse Event
Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
Change From Baseline in the M.D. Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Factor Score After Cycle 3
Baseline and end of cycle 3 of adjuvant temozolomide (approximately 24 weeks after start of chemoradiation)
Change From Baseline in the M.D. Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Factor Score After Cycle 12
Baseline and end of cycle 12 of adjuvant temozolomide (approximately 60 weeks after start of chemoradiation)
- +2 more secondary outcomes
Other Outcomes (3)
CD4 Lymphopenia Count
Baseline to up to 5 years
Use of Magnetic Resonance Diffusion and Perfusion Imaging to Differentiate Between Tumor Progression and Pseudo-progression
Baseline - cycle 4
Use of Magnetic Resonance Diffusion and Perfusion Imaging as Early Predictors of Overall Survival
Baseline up to 12 months
Study Arms (4)
Group 1 - Standard RT (Photon) (Arm A1)
ACTIVE COMPARATORGroup 1 = Photon IMRT centers. Participants undergo standard-dose postoperative photon radiotherapy using 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) administered once daily, 5 days per week. Treatment consists of 46 Gy in 23 fractions followed by a sequential boost to a total dose of 60 Gy in 30 fractions. Participants receive concurrent temozolomide orally once daily during radiotherapy for up to 49 days and adjuvant temozolomide orally once daily on days 1-5 of each 28-day cycle for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Group 2 - Standard RT (Proton) (Arm A2)
ACTIVE COMPARATORGroup 2 = Proton centers. Participants undergo the same standard-dose postoperative radiotherapy regimen described for Arm A1 but delivered using proton beam therapy. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
Group 1 - Intensified RT (Photon) (Arm B)
EXPERIMENTALGroup 1 = Photon IMRT centers. Patients undergo dose-escalated and -intensified photon IMRT QD, 5 days a week for a total of 30 fractions. In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Group 2 - Intensified RT (Proton) (Arm C)
EXPERIMENTALGroup 2 = Proton centers. Participants undergo the same radiotherapy regimen described for Arm B but delivered using proton beam therapy. The elective target volume receives 50 Gy(RBE) in 30 fractions, and the boost target volume receives 75 Gy(RBE) in 30 fractions. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
Interventions
daily fractions
Undergo dose-escalated and -intensified proton beam radiation therapy
tablet
Eligibility Criteria
You may qualify if:
- PRIOR TO STEP 1 REGISTRATION
- A diagnostic contrast-enhanced MRI (no other scan type allowed) of the brain must be performed postoperatively; the residual enhancing tumor and/or resection cavity must have a maximal diameter of 5 cm or less; the tumor diameter will be the greatest diameter as measured on the contrast-enhanced postoperative MRI and will include residual disease and/or the postoperative surgical cavity as appropriate
- The postoperative brain MRI should be obtained within 72 hours of resection; if it is not obtained within 72 hours post-resection, then an MRI obtained 2 weeks or longer after surgery is required and can be utilized to ensure maximal diameter of residual tumor and/or resection cavity is 5 cm or less
- For cases where a gross total resection of enhancing tumor is performed, but postoperative surgical cavity is NOT identifiable, the patient will be excluded from the trial
- Tumor tissue must be available for submission for central pathology review
- Timing requirements:
- If MGMT has been assessed locally by LabCorps or MD Anderson Cancer Center Molecular Diagnostics Lab (MDACC-MDL):
- Tissue for central pathology review and central MGMT assessment and the official LabCorps or MDACC-MDL MGMT result must be received by the NRG Oncology Biospecimen Bank on or before postoperative calendar day 40
- The site's local MGMT report from LabCorp or MDACC-MDL will then be used to stratify the patient; a post-stratification MGMT central review will be performed, but step 2 registration and protocol treatment can proceed without central review of MGMT
- Patients whose tissue for central pathology review and official LabCorps or MDACC-MDL MGMT result cannot be received by NRG Oncology Biospecimen Bank on or before 40 calendar days after surgery may NOT enroll on this trial, as central pathology review and stratification will not be complete in time for the patient to start treatment within 49 calendar days following surgery
- If MGMT has not been assessed locally by LabCorps or MDACC-MDL:
- Tissue for central pathology review and central MGMT assessment must be received by the NRG Oncology Biospecimen Bank on or before postoperative calendar day 30
- Central MGMT analysis will be performed at MDACC-MDL and used for patient stratification; results will be conveyed to NRG Oncology within 10 business days of receipt of the tissue
- Patients who have not had local MGMT assessment by LabCorps or MDACC-MDL and whose tissue for central pathology review cannot be received by NRG Oncology Biospecimen Bank on or before 30 calendar days after surgery may NOT enroll on this trial, as central pathology review and stratification will not be complete in time for the patient to start treatment within 49 calendar days following surgery
- Tissue Requirements:
- +21 more criteria
You may not qualify if:
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 3 years; (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
- Recurrent or multifocal malignant gliomas
- Any site of distant disease (for example, drop metastases from the GBM tumor site)
- Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable (except temozolomide)
- Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted
- Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields
- Severe, active co-morbidity, defined as follows:
- Unstable angina at step 2 registration
- Transmural myocardial infarction within the last 6 months prior to step 2 registration
- Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of \>= 2 mm using the analysis of an electrocardiogram (EKG) performed within 28 days prior to step 2 registration (Note: EKG to be performed only if clinical suspicion of cardiac issue)
- New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to step 2 registration
- Serious and inadequately controlled arrhythmia at step 2 registration
- Serious or non-healing wound, ulcer or bone fracture or history of abdominal fistula, intra-abdominal abscess requiring major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to step 2 registration, with the exception of the craniotomy for surgical resection
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 2 registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NRG Oncologylead
- National Cancer Institute (NCI)collaborator
Study Sites (237)
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
Arizona Oncology Associates-West Orange Grove
Tucson, Arizona, 85704, United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603, United States
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California, 93301, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, 95682, United States
Eden Hospital Medical Center
Castro Valley, California, 94546, United States
Fresno Cancer Center
Fresno, California, 93720, United States
Marin General Hospital
Greenbrae, California, 94904, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Los Angeles General Medical Center
Los Angeles, California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Fremont - Rideout Cancer Center
Marysville, California, 95901, United States
Memorial Medical Center
Modesto, California, 95355, United States
Kaiser Permanente Oakland-Broadway
Oakland, California, 94611, United States
Saint Joseph Hospital - Orange
Orange, California, 92868, 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
Pomona Valley Hospital Medical Center
Pomona, California, 91767, 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
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
South Sacramento Cancer Center
Sacramento, California, 95823, 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
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, 94080, United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, 94086, United States
John Muir Medical Center-Walnut Creek
Walnut Creek, California, 94598, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Boca Raton Regional Hospital
Boca Raton, Florida, 33486, United States
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, 32209, United States
Baptist Medical Center South
Jacksonville, Florida, 32258, United States
Miami Cancer Institute
Miami, Florida, 33176, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory Proton Therapy Center
Atlanta, Georgia, 30308, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, 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
Northwestern University
Chicago, Illinois, 60611, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612, United States
Rush MD Anderson Cancer Center
Chicago, Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Springfield Memorial Hospital
Springfield, Illinois, 62781, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, 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
IU Health Methodist Hospital
Indianapolis, Indiana, 46202, 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
IU Health Ball Memorial Hospital
Muncie, Indiana, 47303, United States
Mercy Hospital
Cedar Rapids, Iowa, 52403, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, 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
Norton Hospital Pavilion and Medical Campus
Louisville, Kentucky, 40202, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, United States
Willis-Knighton Medical and Cancer Center
Shreveport, Louisiana, 71103, United States
Maryland Proton Treatment Center
Baltimore, Maryland, 21201, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
UM Upper Chesapeake Medical Center
Bel Air, Maryland, 21014, 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
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Mass General/North Shore Cancer Center
Danvers, Massachusetts, 01923, United States
Lowell General Hospital
Lowell, Massachusetts, 01854, 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
McLaren Cancer Institute-Bay City
Bay City, Michigan, 48706, United States
Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
McLaren Cancer Institute-Flint
Flint, Michigan, 48532, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503, United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
McLaren Cancer Institute-Lapeer Region
Lapeer, Michigan, 48446, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154, United States
McLaren Cancer Institute-Macomb
Mount Clemens, Michigan, 48043, United States
McLaren Cancer Institute-Central Michigan
Mount Pleasant, Michigan, 48858, United States
McLaren Cancer Institute-Owosso
Owosso, Michigan, 48867, United States
McLaren Cancer Institute-Northern Michigan
Petoskey, Michigan, 49770, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341, United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073, United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085, United States
Corewell Health Beaumont Troy Hospital
Troy, Michigan, 48085, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Saint Luke's Hospital of Duluth
Duluth, Minnesota, 55805, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
North Kansas City Hospital
Kansas City, Missouri, 64116, United States
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Saint Mary's Regional Medical Center
Reno, Nevada, 89503, 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
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Capital Health Medical Center-Hopewell
Pennington, New Jersey, 08534, United States
ProCure Proton Therapy Center-Somerset
Somerset, New Jersey, 08873, United States
Virtua Voorhees
Voorhees Township, New Jersey, 08043, United States
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, 11215, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, 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
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
Mission Hospital
Asheville, North Carolina, 28801, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Cleveland Clinic Akron General
Akron, Ohio, 44307, United States
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122, United States
Geauga Hospital
Chardon, Ohio, 44024, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, 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
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Mercy Cancer Center-Elyria
Elyria, Ohio, 44035, United States
Cleveland Clinic Cancer Center Independence
Independence, Ohio, 44131, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124, 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
University Hospitals Parma Medical Center
Parma, Ohio, 44129, United States
North Coast Cancer Care
Sandusky, Ohio, 44870, United States
UH Seidman Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio, 44870, United States
Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio, 44136, United States
University of Toledo
Toledo, Ohio, 43614, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069, United States
UHHS-Westlake Medical Center
Westlake, Ohio, 44145, United States
Cleveland Clinic Wooster Family Health and Surgery Center
Wooster, Ohio, 44691, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Willamette Valley Cancer Center
Eugene, Oregon, 97401, 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
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, 18512, United States
Ephrata Cancer Center
Ephrata, Pennsylvania, 17522, United States
Adams Cancer Center
Gettysburg, Pennsylvania, 17325, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109, United States
Sechler Family Cancer Center
Lebanon, Pennsylvania, 17042, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania, 19114, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
WellSpan Health-York Cancer Center
York, Pennsylvania, 17403, 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
Self Regional Healthcare
Greenwood, South Carolina, 29646, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Tennessee Cancer Specialists-Dowell Springs
Knoxville, Tennessee, 37909, United States
Dell Seton Medical Center at The University of Texas
Austin, Texas, 78701, United States
Austin Cancer Centers-Central Austin
Austin, Texas, 78702, United States
Texas Oncology-Austin Midtown
Austin, Texas, 78705, United States
Texas Oncology - Central Austin Cancer Center
Austin, Texas, 78731, United States
Texas Oncology - South Austin Cancer Center
Austin, Texas, 78745, United States
Austin Cancer Centers-North
Austin, Texas, 78758, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
Texas Oncology - Denison Cancer Center
Denison, Texas, 75020, United States
Texas Oncology-Flower Mound
Flower Mound, Texas, 75028, United States
Texas Oncology - Fort Worth Cancer Center
Fort Worth, Texas, 76104, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565, United States
Memorial Hermann Memorial City Medical Center
Houston, Texas, 77024, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
UTMB Cancer Center at Victory Lakes
League City, Texas, 77573, United States
Covenant Medical Center-Lakeside
Lubbock, Texas, 79410, United States
Texas Oncology-Seton Williamson
Round Rock, Texas, 78665, United States
Texas Oncology - Round Rock Cancer Center
Round Rock, Texas, 78681, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, 77479, United States
Texas Oncology - Tyler
Tyler, Texas, 75702, 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
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, 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
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, 05819, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
FHCC at Northwest Hospital
Seattle, Washington, 98133, United States
FHCC Proton Therapy Center
Seattle, Washington, 98133, United States
University of Washington Medical Center - Montlake
Seattle, Washington, 98195, United States
Compass Oncology Vancouver
Vancouver, Washington, 98684, United States
Legacy Salmon Creek Hospital
Vancouver, Washington, 98686, United States
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia, 26003, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401, United States
BCCA-Vancouver Island Cancer Centre
Victoria, British Columbia, V8R 6V5, Canada
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario, K1H 8L6, Canada
Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3, 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
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Québec, Quebec, G1R 2J6, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to slower than anticipated accrual in Group 2 (proton centers), the target sample size was reduced, follow-up duration was increased, and the power calculations were revised accordingly, as reflected in the primary outcome measure.
Results Point of Contact
- Title
- Wendy Seiferheld
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
Minesh P Mehta
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
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2014
First Posted
July 1, 2014
Study Start
December 4, 2014
Primary Completion
July 7, 2025
Study Completion (Estimated)
July 7, 2030
Last Updated
October 1, 2026
Results First Posted
August 28, 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.