Radiation Therapy (RT) and Temozolomide (TMZ) in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma
Phase III Trial Comparing Conventional Adjuvant Temozolomide With Dose-Intensive Temozolomide in Patients With Newly Diagnosed Glioblastoma
5 other identifiers
interventional
1,173
2 countries
351
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known which schedule of temozolomide when given together with radiation therapy is more effective in treating glioblastoma or gliosarcoma. PURPOSE: This randomized phase III trial is studying two different schedules of temozolomide to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed glioblastoma or gliosarcoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2006
Longer than P75 for phase_3
351 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
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 15, 2006
CompletedFirst Posted
Study publicly available on registry
March 17, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedResults Posted
Study results publicly available
April 30, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJune 9, 2020
May 1, 2020
5.1 years
March 15, 2006
March 28, 2014
May 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Median Overall Survival Time
Overall survival time is defined as time from registration/randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Analysis occurred after 647 deaths were reported.
From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
Secondary Outcomes (25)
Median Progression-free Survival (PFS) Time
From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
Median Overall Survival Time by MGMT Status
From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
Median Progression-free Survival Time by MGMT Status
From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
Best Treatment Response by MGMT Status
From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
Distribution of Highest Grade AE Reported as Possibly/Probably/Definitely Related to Protocol Treatment
From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
- +20 more secondary outcomes
Study Arms (3)
Conventional adjuvant TMZ
ACTIVE COMPARATORConcurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
Dose-dense adjuvant TMZ
EXPERIMENTALConcurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
No adjuvant TMZ (not randomized )
OTHERConcurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Not randomized to either adjuvant TMZ arm.
Interventions
Daily oral temozolomide (75 mg/m2) up to 49 doses.
60 Gy in 2 Gy fractions
Oral temozolomide on days 1-5 of a 28-day cycle. Dose starts at 150mg/m2 for first cycle, increases to 200mg/m2 for subsequent cycles if no unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive up to 6 more courses of temozolomide.
Oral temozolomide on days 1-21 of a 28-day cycle. Dose starts at 75mg/m2 for first cycle, increases to 100mg/m2 for subsequent cycles if no unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive up to 6 more courses of temozolomide.
Eligibility Criteria
You may qualify if:
- Histopathologically proven diagnosis of glioblastoma. Since gliosarcoma is a variant of glioblastoma, gliosarcoma is also an eligible diagnosis.
- Patients must have at least 1 block of tissue available for analysis of MGMT status; fresh frozen tumor tissue acquisition is encouraged.
- Diagnosis must be established by open biopsy or tumor resection. Patients who have only had a stereotactic biopsy are not eligible.
- The tumor must have a supratentorial component.
- Patients must have recovered from the effects of surgery, postoperative infection, and other complications before study registration.
- A diagnostic contrast-enhanced magnetic resonance imaging (MRI) or computerized tomography (CT) scan (if MRI is not available) of the brain must be performed preoperatively and postoperatively. The postoperative scan must be done within 28 days of registration and prior to the initiation of radiotherapy. Preoperative and postoperative scans must be the same type. If CT scans were performed perioperatively, a CT and an MRI should be performed before randomization.
- Patients unable to undergo MRI imaging because of non-compatible devices can be enrolled, provided pre- and post-operative contrast-enhanced CT scans are obtained and are of sufficient quality.
- Therapy must begin ≤ 5 weeks after the most recent brain tumor surgery.
- History/physical examination within 14 days prior to study registration.
- Neurologic examination within 14 days prior to study registration.
- Documentation of steroid doses within 14 days prior to study registration and stable or decreasing steroid dose within 5 days prior to registration.
- Karnofsky performance status of ≥ 60.
- Age ≥ 18 years.
- Complete blood count (CBC)/differential obtained within 14 days prior to study registration, with adequate bone marrow function as defined below: 13.1 Absolute neutrophil count (ANC) ≥ 1500 cells/mm3. 13.2 Platelets ≥ 100,000 cells/mm3. 13.3 Hemoglobin ≥ 10 g/dl. (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10 g/dl is acceptable.)
- Adequate renal function, as defined below:
- +7 more criteria
You may not qualify if:
- Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible).
- Recurrent or multifocal malignant gliomas
- Metastases detected below the tentorium or beyond the cranial vault.
- Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable. Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted. See Section 1.
- 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 and/or congestive heart failure requiring hospitalization.
- Transmural myocardial infarction within the last 6 months.
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
- Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
- Major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.
- Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity.
- Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant due to study drug;
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radiation Therapy Oncology Grouplead
- National Cancer Institute (NCI)collaborator
- European Organisation for Research and Treatment of Cancer - EORTCcollaborator
- NRG Oncologycollaborator
Study Sites (351)
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701, United States
Arizona Oncology Services Foundation
Phoenix, Arizona, 85013, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259-5499, United States
Arizona Oncology - Tucson
Tucson, Arizona, 85704, United States
Auburn Radiation Oncology
Auburn, California, 95603, United States
Providence Saint Joseph Medical Center - Burbank
Burbank, California, 91505, United States
Radiation Oncology Centers - Cameron Park
Cameron Park, California, 95682, United States
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California, 95608, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000, United States
Kaiser Permanente Medical Center - Los Angeles
Los Angeles, California, 90027, United States
Radiation Oncology Center - Roseville
Roseville, California, 95661, United States
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, 95815, United States
Mercy General Hospital
Sacramento, California, 95819, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115, United States
Solano Radiation Oncology Center
Vacaville, California, 95687, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, 80933, United States
Poudre Valley Radiation Oncology
Fort Collins, Colorado, 80528, United States
Yale Cancer Center
New Haven, Connecticut, 06520-8028, United States
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, 19958, United States
CCOP - Christiana Care Health Services
Newark, Delaware, 19713, United States
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
Boca Raton, Florida, 33486, United States
University of Florida Shands Cancer Center
Gainesville, Florida, 32610-0232, United States
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, 32207, United States
Integrated Community Oncology Network at Southside Cancer Center
Jacksonville, Florida, 32207, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224, United States
Baptist Medical Center South
Jacksonville, Florida, 32258, United States
Integrated Community Oncology Network
Jacksonville Beach, Florida, 32250, United States
Baptist-South Miami Regional Cancer Program
Miami, Florida, 33176, United States
Integrated Community Oncology Network - Orange Park
Orange Park, Florida, 32073, United States
Florida Cancer Center - Palatka
Palatka, Florida, 32177, United States
Flagler Cancer Center
Saint Augustine, Florida, 32086, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, 33612-9497, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
John B. Amos Cancer Center
Columbus, Georgia, 31904, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706, United States
Northwest Community Hospital
Arlington Heights, Illinois, 60005, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, 60504, United States
St. Joseph Medical Center
Bloomington, Illinois, 61701, United States
Graham Hospital
Canton, Illinois, 61520, United States
Memorial Hospital
Carthage, Illinois, 62321, United States
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, 60612-3785, United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470, United States
Eureka Community Hospital
Eureka, Illinois, 61530, United States
Galesburg Clinic, PC
Galesburg, Illinois, 61401, United States
Galesburg Cottage Hospital
Galesburg, Illinois, 61401, United States
InterCommunity Cancer Center of Western Illinois
Galesburg, Illinois, 61401, United States
Mason District Hospital
Havana, Illinois, 62644, United States
Hopedale Medical Complex
Hopedale, Illinois, 61747, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, 60435, United States
McDonough District Hospital
Macomb, Illinois, 61455, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, 60153, United States
BroMenn Regional Medical Center
Normal, Illinois, 61761, United States
Community Cancer Center
Normal, Illinois, 61761, United States
Community Hospital of Ottawa
Ottawa, Illinois, 61350, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, 61350, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, 61554, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
OSF St. Francis Medical Center
Peoria, Illinois, 61615-7827, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61615, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
Illinois Valley Community Hospital
Peru, Illinois, 61354, United States
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
St. Margaret's Hospital
Spring Valley, Illinois, 61362, United States
Valley Cancer Center
Spring Valley, Illinois, 61362, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Radiation Oncology Associates Southwest
Fort Wayne, Indiana, 46804, United States
Parkview Regional Cancer Center at Parkview Health
Fort Wayne, Indiana, 46805, United States
Central Indiana Cancer Centers - East
Indianapolis, Indiana, 46219, United States
Howard Community Hospital
Kokomo, Indiana, 46904, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, 46350, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, 46360, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Saint Joseph Regional Medical Center
South Bend, Indiana, 46617, United States
South Bend Clinic
South Bend, Indiana, 46617, United States
McFarland Clinic, PC
Ames, Iowa, 50010, United States
Mercy Capitol Hospital
Des Moines, Iowa, 50307, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, 50401, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, 67068, United States
Southwest Medical Center
Liberal, Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, 67114, United States
Menorah Medical Center
Overland Park, Kansas, 66209, United States
Kansas City Cancer Centers - Southwest
Overland Park, Kansas, 66210, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, 67042, United States
Shawnee Mission Medical Center
Shawnee Mission, Kansas, 66204, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, 67214, United States
CCOP - Wichita
Wichita, Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Wesley Medical Center
Wichita, Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, 67156, United States
DeCesaris Cancer Institute at Anne Arundel Medical Center
Annapolis, Maryland, 21401, United States
St. Agnes Hospital Cancer Center
Baltimore, Maryland, 21229, United States
Union Hospital Cancer Program at Union Hospital
Elkton, Maryland, 21921, United States
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, 49221, United States
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, 48106-0995, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, 48123-2500, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, 48202, United States
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, 49431, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, 48236, United States
Dickinson County Healthcare System
Iron Mountain, Michigan, 49801, United States
Foote Memorial Hospital
Jackson, Michigan, 49201, United States
Borgess Medical Center
Kalamazoo, Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville, Michigan, 48144, United States
Sparrow Regional Cancer Center
Lansing, Michigan, 48912-1811, United States
St. Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Community Cancer Center of Monroe
Monroe, Michigan, 48162, United States
Mercy Memorial Hospital - Monroe
Monroe, Michigan, 48162, United States
St. Joseph Mercy Oakland
Pontiac, Michigan, 48341-2985, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, 48060, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, 48073, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, 48601, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, 49085, United States
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield, Michigan, 48075, United States
St. John Macomb Hospital
Warren, Michigan, 48093, United States
Unknown Facility
Alexandria, Minnesota, 56308, United States
MeritCare Bemidji
Bemidji, Minnesota, 56601, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Unknown Facility
Fergus Falls, Minnesota, 56537, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, 55432, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, 55422-2900, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, 56303, United States
Coborn Cancer Center
Saint Cloud, Minnesota, 56303, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, 55416, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, 55125, United States
Independence Regional Health Center
Independence, Missouri, 64050, United States
St. John's Regional Medical Center
Joplin, Missouri, 64804, United States
Truman Medical Center - Hospital Hill
Kansas City, Missouri, 64108, United States
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City, Missouri, 64111, United States
St. Joseph Medical Center
Kansas City, Missouri, 64114, United States
North Kansas City Hospital
Kansas City, Missouri, 64116, United States
Parvin Radiation Oncology
Kansas City, Missouri, 64116, United States
CCOP - Kansas City
Kansas City, Missouri, 64131, United States
Kansas City Cancer Centers - South
Kansas City, Missouri, 64131, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Liberty Hospital
Liberty, Missouri, 64068, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65802, United States
St. John's Regional Health Center
Springfield, Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101, United States
St. Vincent Healthcare Cancer Care Services
Billings, Montana, 59101, United States
Billings Clinic - Downtown
Billings, Montana, 59107-7000, United States
St. James Healthcare Cancer Care
Butte, Montana, 59701, United States
Great Falls Clinic - Main Facility
Great Falls, Montana, 59405, United States
Unknown Facility
Great Falls, Montana, 59405, United States
Northern Montana Hospital
Havre, Montana, 59501, United States
Glacier Oncology, PLLC
Kalispell, Montana, 59901, United States
Kalispell Medical Oncology at KRMC
Kalispell, Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Community Medical Center
Missoula, Montana, 59801, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, 59804, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, 59807-7877, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, 59807, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, 68848-1990, United States
Cancer Resource Center - Lincoln
Lincoln, Nebraska, 68510, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106, United States
Methodist Estabrook Cancer Center
Omaha, Nebraska, 68114, United States
Immanuel Medical Center
Omaha, Nebraska, 68122, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
Creighton University Medical Center
Omaha, Nebraska, 68131-2197, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
Dartmouth - Hitchcock Concord
Concord, New Hampshire, 03301, United States
Kingsbury Center for Cancer Care at Cheshire Medical Center
Keene, New Hampshire, 03431, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0002, United States
St. Barnabas Medical Center Cancer Center
Livingston, New Jersey, 07039, United States
Frederick R. and Betty M. Smith Cancer Treatment Center
Sparta, New Jersey, 07871, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, 08043, United States
New York Methodist Hospital
Brooklyn, New York, 11215, United States
Monter Cancer Center of the North Shore-LIJ Health System
Lake Success, New York, 11042, United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030, United States
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York, 11030, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Hudson Valley Oncology Associates
Poughkeepsie, New York, 12601, United States
Lipson Cancer and Blood Center at Rochester General Hospital
Rochester, New York, 14621, United States
Mission Hospitals - Memorial Campus
Asheville, North Carolina, 28801, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534, United States
Wayne Radiation Oncology
Goldsboro, North Carolina, 27534, United States
Rutherford Hospital
Rutherfordton, North Carolina, 28139, United States
Wilmed Radiation Oncology Services
Wilson, North Carolina, 27893, United States
CCOP - MeritCare Hospital
Fargo, North Dakota, 58122, United States
MeritCare Broadway
Fargo, North Dakota, 58122, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, 44307, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, 44309-2090, United States
Mary Rutan Hospital
Bellefontaine, Ohio, 43311, United States
Wood County Oncology Center
Bowling Green, Ohio, 43402, United States
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, 44710-1799, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, 43214-3998, United States
CCOP - Columbus
Columbus, Ohio, 43215, United States
Grant Medical Center Cancer Care
Columbus, Ohio, 43215, United States
Mount Carmel Health - West Hospital
Columbus, Ohio, 43222, United States
Doctors Hospital at Ohio Health
Columbus, Ohio, 43228, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Cleveland Clinic Cancer Center
Independence, Ohio, 44131, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
Lima Memorial Hospital
Lima, Ohio, 45804, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
Northwest Ohio Oncology Center
Maumee, Ohio, 43537, United States
St. Luke's Hospital
Maumee, Ohio, 43537, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, 43055, United States
St. Charles Mercy Hospital
Oregon, Ohio, 43616, United States
Toledo Clinic - Oregon
Oregon, Ohio, 43616, United States
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
Salem, Ohio, 44460, United States
North Coast Cancer Care, Incorporated
Sandusky, Ohio, 44870, United States
Mercy Medical Center
Springfield, Ohio, 45504, United States
Community Hospital of Springfield and Clark County
Springfield, Ohio, 45505, United States
Flower Hospital Cancer Center
Sylvania, Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, 44883, United States
Toledo Hospital
Toledo, Ohio, 43606, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608, United States
Medical University of Ohio Cancer Center
Toledo, Ohio, 43614, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43617, United States
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, 43623, United States
Fulton County Health Center
Wauseon, Ohio, 43567, United States
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, 43081, United States
Cancer Treatment Center
Wooster, Ohio, 44691, United States
Genesis - Good Samaritan Hospital
Zanesville, Ohio, 43701, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, 73104, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, 74136, United States
Willamette Valley Cancer Center - Eugene
Eugene, Oregon, 97401, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, 97222, United States
Legacy Good Samaritan Hospital & Comprehensive Cancer Center
Portland, Oregon, 97210, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, 97213-2967, United States
Adventist Medical Center
Portland, Oregon, 97216, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Legacy Emanuel Hospital and Health Center and Children's Hospital
Portland, Oregon, 97227, United States
Salem Hospital Regional Cancer Care Services
Salem, Oregon, 97309-5014, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, 97062, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, 18105, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, 17822-0001, United States
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, 18512, United States
Dale and Frances Hughes Cancer Center at Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Riddle Memorial Hospital Cancer Center
Media, Pennsylvania, 19063, United States
Upper Delaware Valley Cancer Center
Milford, Pennsylvania, 18337, United States
Intercommunity Cancer Center
Monroeville, Pennsylvania, 15146, United States
Alle-Kiski Medical Center
Natrona Heights, Pennsylvania, 15065, United States
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, 19301-1792, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497, United States
Frankford Hospital Cancer Center - Torresdale Campus
Philadelphia, Pennsylvania, 19114, United States
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052, United States
Somerset Oncology Center
Somerset, Pennsylvania, 15501, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711, United States
CCOP - Main Line Health
Wynnewood, Pennsylvania, 19096, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, 19096, United States
AnMed Cancer Center
Anderson, South Carolina, 29621, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Medical X-Ray Center, PC
Sioux Falls, South Dakota, 57105, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, 57117-5039, United States
Thompson Cancer Survival Center West
Knoxville, Tennessee, 37392, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916, United States
Thompson Cancer Survival Center at Methodist
Oak Ridge, Tennessee, 37830, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
Texas Oncology, PA at Texas Cancer Center Dallas Southwest
Dallas, Texas, 75237, United States
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
Fort Worth, Texas, 76104, United States
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410-1894, United States
Texas Oncology, PA at Texas Cancer Center - Sherman
Sherman, Texas, 75090, United States
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, 77479, United States
American Fork Hospital
American Fork, Utah, 84003, United States
Sandra L. Maxwell Cancer Center
Cedar City, Utah, 84720, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, 84157, United States
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, 84604, United States
LDS Hospital
Salt Lake City, Utah, 84103, United States
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, 84106, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112, United States
Dixie Regional Medical Center - East Campus
St. George, Utah, 84770, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, 05401, United States
Norris Cotton Cancer Center - North
Saint Johnsbury, Vermont, 05819, United States
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, 22401, United States
Sentara Cancer Institute at Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298-0037, United States
St. Joseph Cancer Center
Bellingham, Washington, 98225, United States
St. Francis Hospital
Federal Way, Washington, 98003, United States
Cascade Cancer Center at Evergreen Hospital Medical Center
Kirkland, Washington, 98033, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, 98195-6043, United States
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, 98668, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, 98902, United States
Theda Care Cancer Institute
Appleton, Wisconsin, 54911, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54301-3526, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, 54303, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, 54303, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54307-3508, United States
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Community Memorial Hospital Cancer Care Center
Menomonee Falls, Wisconsin, 53051, United States
Regional Cancer Center at Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
Door County Cancer Center at Door County Memorial Hospital
Sturgeon Bay, Wisconsin, 54235-1495, United States
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235, United States
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, 53188, United States
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, T2N 4N2, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, K1Y 4K7, Canada
Cancer Care Program at Thunder Bay Regional Health Sciences
Thunder Bay, Ontario, P7B 6V4, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
McGill Cancer Centre at McGill University
Montreal, Quebec, H2W 1S6, Canada
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, G1R 2J6, Canada
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, S4T 7T1, Canada
Related Publications (6)
Aldape KD, Wang M, Sulman EP, et al.: RTOG 0525: molecular correlates from a randomized phase III trial of newly diagnosed glioblastoma. [Abstract] J Clin Oncol 29 (Suppl 15): A-LBA2000, 2011.
RESULTArmstrong TS, Wefel JS, Wang M, et al.: Clinical utility of neurocognitive function (NCF), quality of life (QOL), and symptom assessment as prognostic factors for survival and measures of treatment effects on RTOG 0525. [Abstract] J Clin Oncol 29 (Suppl 15): A-2016, 2011.
RESULTWang M, Dignam JJ, Won M, Curran W, Mehta M, Gilbert MR. Variation over time and interdependence between disease progression and death among patients with glioblastoma on RTOG 0525. Neuro Oncol. 2015 Jul;17(7):999-1006. doi: 10.1093/neuonc/nov009. Epub 2015 Feb 16.
PMID: 25688120RESULTAldape KD, Jones G, Wang M, et al.: MGMT methylation testing in RTOG 0525: A phase III trial of newly diagnosed glioblastoma. [Abstract] J Clin Oncol 27 (Suppl 15): A-2051, 2009.
RESULTGilbert MR, Wang M, Aldape KD, Stupp R, Hegi ME, Jaeckle KA, Armstrong TS, Wefel JS, Won M, Blumenthal DT, Mahajan A, Schultz CJ, Erridge S, Baumert B, Hopkins KI, Tzuk-Shina T, Brown PD, Chakravarti A, Curran WJ Jr, Mehta MP. Dose-dense temozolomide for newly diagnosed glioblastoma: a randomized phase III clinical trial. J Clin Oncol. 2013 Nov 10;31(32):4085-91. doi: 10.1200/JCO.2013.49.6968. Epub 2013 Oct 7.
PMID: 24101040RESULTBell EH, Pugh SL, McElroy JP, Gilbert MR, Mehta M, Klimowicz AC, Magliocco A, Bredel M, Robe P, Grosu AL, Stupp R, Curran W Jr, Becker AP, Salavaggione AL, Barnholtz-Sloan JS, Aldape K, Blumenthal DT, Brown PD, Glass J, Souhami L, Lee RJ, Brachman D, Flickinger J, Won M, Chakravarti A. Molecular-Based Recursive Partitioning Analysis Model for Glioblastoma in the Temozolomide Era: A Correlative Analysis Based on NRG Oncology RTOG 0525. JAMA Oncol. 2017 Jun 1;3(6):784-792. doi: 10.1001/jamaoncol.2016.6020.
PMID: 28097324DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Only participants registered after 07-12-2007 were able to participate in the quality of life / patient reported outcome study components.
Results Point of Contact
- Title
- Wendy Seiferheld
- Organization
- Radiation Therapy Oncology Group (RTOG)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark R. Gilbert, MD
M.D. Anderson Cancer Center
- STUDY CHAIR
Minesh P. Mehta, MD
University of Wisconsin, Madison
- STUDY CHAIR
Roger Stupp, MD
Centre Hospitalier Universitaire Vaudois
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2006
First Posted
March 17, 2006
Study Start
January 1, 2006
Primary Completion
February 1, 2011
Study Completion
December 1, 2016
Last Updated
June 9, 2020
Results First Posted
April 30, 2014
Record last verified: 2020-05