Radiation Therapy (RT) and Temozolomide (TMZ) in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00304031
First received: March 15, 2006
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: Concurrent temozolomide
Radiation: Concurrent radiation therapy
Drug: 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle
Drug: 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Trial Comparing Conventional Adjuvant Temozolomide With Dose-Intensive Temozolomide in Patients With Newly Diagnosed Glioblastoma

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after 647 deaths have been reported. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: From randomization to date of progression, death or last follow-up. Analysis occurs after 647 deaths have been reported. ] [ Designated as safety issue: No ]
  • Comparison of OS and PFS in Patients With Unmethylated MGMT [ Time Frame: From randomization to date of progression, death or last follow-up. Analysis occurs after 647 deaths have been reported. ] [ Designated as safety issue: No ]
  • Comparison of OS and PFS in Patients With Methylated MGMT [ Time Frame: From randomization to date of progression, death or last follow-up. Analysis occurs after 647 deaths have been reported. ] [ Designated as safety issue: No ]
  • Correlation of Tumor MGMT Gene Methylation Status With Treatment Response [ Time Frame: From randomization to date of progression, death or last follow-up. Analysis occurs after 647 deaths have been reported. ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: From start of treatment to end of follow-up ] [ Designated as safety issue: Yes ]
  • Correlation of PFS With OS at 6 Months [ Time Frame: From randomization to date of progression, death or last follow-up. Analysis occurs after 647 deaths have been reported. ] [ Designated as safety issue: No ]

Enrollment: 1173
Study Start Date: January 2006
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional adjuvant TMZ
Concurrent 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.
Drug: Concurrent temozolomide
Daily oral temozolomide (75 mg/m2) up to 49 doses.
Radiation: Concurrent radiation therapy
60 Gy in 2 Gy fractions
Drug: 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle
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.
Experimental: Dose-dense adjuvant TMZ
Concurrent 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.
Drug: Concurrent temozolomide
Daily oral temozolomide (75 mg/m2) up to 49 doses.
Radiation: Concurrent radiation therapy
60 Gy in 2 Gy fractions
Drug: 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle
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.
No adjuvant TMZ (not randomized )
Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Not randomized to either adjuvant TMZ arm.
Drug: Concurrent temozolomide
Daily oral temozolomide (75 mg/m2) up to 49 doses.
Radiation: Concurrent radiation therapy
60 Gy in 2 Gy fractions

Detailed Description:

OBJECTIVES:

Primary

  • Determine if dose-intensifying (increasing the "dose-density") the adjuvant temozolomide component of the chemoradiation treatment enhances treatment efficacy as measured by overall survival of patients with newly diagnosed glioblastoma or gliosarcoma.

Secondary

  • Determine if dose-intensifying the adjuvant temozolomide component of the chemoradiation treatment enhances treatment efficacy as measured by progression-free survival.
  • Determine in patients with unmethylated MGMT (O6-methylguanine-DNA methyltransferase) if dose-intensifying the adjuvant temozolomide component of the chemoradiation treatment enhances treatment efficacy (overall and progression-free survival) compared with patients receiving conventional temozolomide dosing.
  • Determine in patients with methylated MGMT if dose-intensifying the adjuvant temozolomide component of the chemoradiation treatment enhances treatment efficacy (overall and progression-free survival) compared with patients receiving conventional temozolomide dosing.
  • Determine if there is an association between tumor MGMT gene methylation status and treatment response.
  • Compare and record the toxicities of the conventional and dose-intense chemotherapy regimens.
  • Evaluate whether 6-month progression-free survival is associated with overall survival.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to recursive partitioning analysis class (III vs IV vs V), MGMT gene methylation status (methylated vs nonmethylated vs indeterminate), and radiotherapy criteria used (standard vs revised European).

Patients undergo radiotherapy daily, 5 days per week for 6 weeks. Patients also receive oral temozolomide daily during radiotherapy. Patients are then randomized to 1 of 2 treatment arms. Randomized treatment begins approximately 4 weeks after completion of radiotherapy.

  • Arm I: Patients receive oral temozolomide on days 1-5.
  • Arm II: Patients receive oral temozolomide on days 1-21. In both arms, 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.

After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 2 years, and then every 6 months thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: This study requires 750 patients randomized to the two treatment arms.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven glioblastoma or gliosarcoma

    • Diagnosis must be made by open biopsy or tumor resection

      • Diagnosis by stereotactic biopsy not allowed
    • Tumor must have supratentorial component
    • Contrast-enhanced MRI or CT scan (if MRI is not available) of the brain must be performed preoperatively and postoperatively prior to initiation of radiotherapy, within 28 days prior to study entry

      • If pre- and postoperative contrast-enhanced CT scans are obtained, must be of sufficient quality
  • Meets 1 of the following recursive positioning analysis classifications:

    • Class III

      • Age < 50 years and Karnofsky performance status (KPS) 90-100%
    • Class IV, meeting 1 of the following criteria:

      • Age < 50 years and KPS < 90%
      • Age ≥ 50 years and KPS 70-100% and underwent prior partial or total tumor resection with no worse than minor neurofunction impairment
    • Class V, meeting 1 of the following criteria:

      • Age ≥ 50 years and KPS 70-100% and underwent prior partial or total tumor resection with worse than minor neurofunction impairment
      • Age ≥ 50 years and KPS 70-100% and underwent prior tumor biopsy only
      • Age ≥ 50 years and KPS < 70%
  • Underwent most recent brain tumor surgery within the past 5 weeks
  • No recurrent or multifocal malignant gliomas
  • At least 1 block of tissue available for analysis of MGMT gene methylation status
  • No metastases detected below the tentorium or beyond the cranial vault

PATIENT CHARACTERISTICS:

  • KPS 60-100%
  • Absolute neutrophil count ≥ 1,500 cells/mm^3
  • Platelet count ≥ 100,000 cells/mm^3
  • Hemoglobin ≥ 10 g/dL (transfusion or other intervention allowed)
  • BUN (blood urea nitrogen) ≤ 25 mg/dL
  • Creatinine ≤ 1.7 mg/dL
  • Bilirubin ≤ 2.0 mg/dL
  • AST (aspartate aminotransferase ) and ALT (alanine amino transferase) ≤ 3 times normal
  • Negative pregnancy test
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No prior invasive malignancy (except for nonmelanomatous skin cancer) unless patient is disease free for ≥ 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix allowed)
  • No severe, active comorbidity, including any of the following:

    • 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
    • Known hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
    • Known AIDS based upon current CDC (Center for Disease Control) definition
    • 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 scleredema that, in the opinion of the treating physician, may put the patient at high risk for radiation toxicity
  • No prior allergic reaction to temozolomide

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from the effects of surgery, postoperative infection, and other complications prior to study entry
  • No prior chemotherapy or radiosensitizers (including polifeprosan 20 with carmustine implant [Gliadel wafers] or any other intratumoral or intracavitary treatment) for cancers of the head and neck region

    • Prior chemotherapy for a different cancer is allowed
  • No prior radiotherapy to the head or neck (except for T1 glottic cancer) that would result in an overlap of radiation fields
  • No treatment on other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study
  • No concurrent prophylactic growth factors
  • No other concurrent investigational drugs
  • No concurrent surgical procedures for tumor debulking
  • No other concurrent chemotherapy, immunotherapy, or biologic therapy
  • No additional concurrent stereotactic boost radiotherapy
  • No concurrent intensity-modulated radiotherapy
  • Concurrent steroids allowed provided dose is stable or decreasing in the past 5 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304031

  Hide Study Locations
Locations
United States, Alaska
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
Fairbanks, Alaska, United States, 99701
United States, Arizona
Arizona Oncology Services Foundation
Phoenix, Arizona, United States, 85013
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
Arizona Oncology - Tucson
Tucson, Arizona, United States, 85704
United States, California
Auburn Radiation Oncology
Auburn, California, United States, 95603
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
Radiation Oncology Centers - Cameron Park
Cameron Park, California, United States, 95682
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California, United States, 95608
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Kaiser Permanente Medical Center - Los Angeles
Los Angeles, California, United States, 90027
Radiation Oncology Center - Roseville
Roseville, California, United States, 95661
Mercy General Hospital
Sacramento, California, United States, 95819
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States, 95815
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Solano Radiation Oncology Center
Vacaville, California, United States, 95687
United States, Colorado
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
Poudre Valley Radiation Oncology
Fort Collins, Colorado, United States, 80528
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06520-8028
United States, Delaware
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States, 19958
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Florida
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
Boca Raton, Florida, United States, 33486
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
Integrated Community Oncology Network at Southside Cancer Center
Jacksonville, Florida, United States, 32207
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
Integrated Community Oncology Network
Jacksonville Beach, Florida, United States, 32250
Baptist Medical Center South
Jascksonville, Florida, United States, 32258
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States, 33176
Integrated Community Oncology Network - Orange Park
Orange Park, Florida, United States, 32073
Florida Cancer Center - Palatka
Palatka, Florida, United States, 32177
Flagler Cancer Center
Saint Augustine, Florida, United States, 32086
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
John B. Amos Cancer Center
Columbus, Georgia, United States, 31904
United States, Idaho
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
Northwest Community Hospital
Arlington Heights, Illinois, United States, 60005
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60504
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
Graham Hospital
Canton, Illinois, United States, 61520
Memorial Hospital
Carthage, Illinois, United States, 62321
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612-3785
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Galesburg Clinic, PC
Galesburg, Illinois, United States, 61401
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
InterCommunity Cancer Center of Western Illinois
Galesburg, Illinois, United States, 61401
Mason District Hospital
Havana, Illinois, United States, 62644
Hopedale Medical Complex
Hopedale, Illinois, United States, 61747
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
McDonough District Hospital
Macomb, Illinois, United States, 61455
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Community Cancer Center
Normal, Illinois, United States, 61761
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States, 61350
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
Proctor Hospital
Peoria, Illinois, United States, 61614
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61615-7827
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Valley Cancer Center
Spring Valley, Illinois, United States, 61362
St. Margaret's Hospital
Spring Valley, Illinois, United States, 61362
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
United States, Indiana
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Radiation Oncology Associates Southwest
Fort Wayne, Indiana, United States, 46804
Parkview Regional Cancer Center at Parkview Health
Fort Wayne, Indiana, United States, 46805
Central Indiana Cancer Centers - East
Indianapolis, Indiana, United States, 46219
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
South Bend Clinic
South Bend, Indiana, United States, 46617
United States, Iowa
McFarland Clinic, PC
Ames, Iowa, United States, 50010
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States, 50314
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Mercy Capitol Hospital
Des Moines, Iowa, United States, 50307
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, United States, 50401
United States, Kansas
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Southwest Medical Center
Liberal, Kansas, United States, 67901
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Kansas City Cancer Centers - Southwest
Overland Park, Kansas, United States, 66210
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67042
Shawnee Mission Medical Center
Shawnee Mission, Kansas, United States, 66204
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
CCOP - Wichita
Wichita, Kansas, United States, 67214
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Wesley Medical Center
Wichita, Kansas, United States, 67214
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
United States, Maryland
DeCesaris Cancer Institute at Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
St. Agnes Hospital Cancer Center
Baltimore, Maryland, United States, 21229
Union Hospital Cancer Program at Union Hospital
Elkton MD, Maryland, United States, 21921
United States, Michigan
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States, 48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States, 49431
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Hurley Medical Center
Flint, Michigan, United States, 48503
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Dickinson County Healthcare System
Iron Mountain, Michigan, United States, 49801
Foote Memorial Hospital
Jackson, Michigan, United States, 49201
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville, Michigan, United States, 48144
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48912-1811
St. Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
Mercy Memorial Hospital - Monroe
Monroe, Michigan, United States, 48162
St. Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States, 48060
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States, 48601
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield, Michigan, United States, 48075
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan, United States, 49085
St. John Macomb Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Alexandria, Minnesota, United States, 56308
MeritCare Bemidji
Bemidji, Minnesota, United States, 56601
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Fergus Falls, Minnesota, United States, 56537
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States, 55109
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Coborn Cancer Center
Saint Cloud, Minnesota, United States, 56303
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, United States, 56303
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55416
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United Hospital
Saint Paul, Minnesota, United States, 55102
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, United States, 55125
United States, Missouri
Independence Regional Health Center
Independence, Missouri, United States, 64050
St. John's Regional Medical Center
Joplin, Missouri, United States, 64804
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
St. Joseph Medical Center
Kansas City, Missouri, United States, 64114
Truman Medical Center - Hospital Hill
Kansas City, Missouri, United States, 64108
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Parvin Radiation Oncology
Kansas City, Missouri, United States, 64116
Research Medical Center
Kansas City, Missouri, United States, 64132
Kansas City Cancer Centers - South
Kansas City, Missouri, United States, 64131
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
Liberty Hospital
Liberty, Missouri, United States, 64068
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64506
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
United States, Montana
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States, 59101
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
St. James Healthcare Cancer Care
Butte, Montana, United States, 59701
Great Falls, Montana, United States, 59405
Great Falls Clinic - Main Facility
Great Falls, Montana, United States, 59405
Northern Montana Hospital
Havre, Montana, United States, 59501
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology at KRMC
Kalispell, Montana, United States, 59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
Community Medical Center
Missoula, Montana, United States, 59801
Guardian Oncology and Center for Wellness
Missoula, Montana, United States, 59804
United States, Nebraska
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, United States, 68848-1990
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States, 68510
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States, 68114
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Creighton University Medical Center
Omaha, Nebraska, United States, 68131-2197
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
United States, New Hampshire
Dartmouth - Hitchcock Concord
Concord, New Hampshire, United States, 03301
Kingsbury Center for Cancer Care at Cheshire Medical Center
Keene, New Hampshire, United States, 03431
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
St. Barnabas Medical Center Cancer Center
Livingston, New Jersey, United States, 07039
Frederick R. and Betty M. Smith Cancer Treatment Center
Sparta, New Jersey, United States, 07871
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, New York
New York Methodist Hospital
Brooklyn, New York, United States, 11215
Monter Cancer Center of the North Shore-LIJ Health System
Lake Success, New York, United States, 11042
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York, United States, 11030
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Hudson Valley Oncology Associates
Poughkeepsie, New York, United States, 12601
Lipson Cancer and Blood Center at Rochester General Hospital
Rochester, New York, United States, 14621
United States, North Carolina
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
Wayne Radiation Oncology
Goldsboro, North Carolina, United States, 27534
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
Wilmed Radiation Oncology Services
Wilson, North Carolina, United States, 27893
United States, North Dakota
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
MeritCare Broadway
Fargo, North Dakota, United States, 58122
United States, Ohio
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States, 44307
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States, 44309-2090
Mary Rutan Hospital
Bellefontaine, Ohio, United States, 43311
Wood County Oncology Center
Bowling Green, Ohio, United States, 43402
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, United States, 44710-1799
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
Grant Medical Center Cancer Care
Columbus, Ohio, United States, 43215
CCOP - Columbus
Columbus, Ohio, United States, 43215
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Cleveland Clinic Cancer Center
Independence, Ohio, United States, 44131
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
St. Luke's Hospital
Maumee, Ohio, United States, 43537
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
Toledo Clinic - Oregon
Oregon, Ohio, United States, 43616
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
Salem, Ohio, United States, 44460
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States, 44870
Mercy Medical Center
Springfield, Ohio, United States, 45504
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43617
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
Toledo Hospital
Toledo, Ohio, United States, 43606
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States, 43081
Cancer Treatment Center
Wooster, Ohio, United States, 44691
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Willamette Valley Cancer Center - Eugene
Eugene, Oregon, United States, 97401
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Providence Milwaukie Hospital
Milwaukie, Oregon, United States, 97222
Legacy Good Samaritan Hospital & Comprehensive Cancer Center
Portland, Oregon, United States, 97210
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
Adventist Medical Center
Portland, Oregon, United States, 97216
Legacy Emanuel Hospital and Health Center and Children's Hospital
Portland, Oregon, United States, 97227
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Salem Hospital Regional Cancer Care Services
Salem, Oregon, United States, 97309-5014
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States, 18105
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, United States, 18512
Dale and Frances Hughes Cancer Center at Pocono Medical Center
East Stroudsburg, Pennsylvania, United States, 18301
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Riddle Memorial Hospital Cancer Center
Media, Pennsylvania, United States, 19063
Upper Delaware Valley Cancer Center
Milford, Pennsylvania, United States, 18337
Intercommunity Cancer Center
Monroeville, Pennsylvania, United States, 15146
Alle-Kiski Medical Center
Natrona Heights, Pennsylvania, United States, 15065
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Frankford Hospital Cancer Center - Torresdale Campus
Philadelphia, Pennsylvania, United States, 19114
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
Somerset Oncology Center
Somerset, Pennsylvania, United States, 15501
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
CCOP - Main Line Health
Wynnewood, Pennsylvania, United States, 19096
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
United States, South Carolina
AnMed Cancer Center
Anderson, South Carolina, United States, 29621
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Tennessee
Thompson Cancer Survival Center West
Knoxville, Tennessee, United States, 37392
Thompson Cancer Survival Center
Knoxville, Tennessee, United States, 37916
Thompson Cancer Survival Center at Methodist
Oak Ridge, Tennessee, United States, 37830
United States, Texas
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Texas Oncology, PA at Texas Cancer Center Dallas Southwest
Dallas, Texas, United States, 75237
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
Fort Worth, Texas, United States, 76104
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410-1894
Texas Oncology, PA at Texas Cancer Center - Sherman
Sherman, Texas, United States, 75090
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, United States, 77479
United States, Utah
American Fork Hospital
American Fork, Utah, United States, 84003
Sandra L. Maxwell Cancer Center
Cedar City, Utah, United States, 84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, United States, 84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
Dixie Regional Medical Center - East Campus
Saint George, Utah, United States, 84770
LDS Hospital
Salt Lake City, Utah, United States, 84103
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States, 84106
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05401
Norris Cotton Cancer Center - North
Saint Johnsbury, Vermont, United States, 05819
United States, Virginia
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, United States, 22401
Sentara Cancer Institute at Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
United States, Washington
St. Joseph Cancer Center
Bellingham, Washington, United States, 98225
St. Francis Hospital
Federal Way, Washington, United States, 98003
Cascade Cancer Center at Evergreen Hospital Medical Center
Kirkland, Washington, United States, 98033
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
CCOP - Virginia Mason Research Center
Seattle, Washington, United States, 98101
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States, 98668
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
United States, Wisconsin
Theda Care Cancer Institute
Appleton, Wisconsin, United States, 54911
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54301-3526
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Community Memorial Hospital Cancer Care Center
Menomonee Falls, Wisconsin, United States, 53051
Regional Cancer Center at Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States, 53066
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Door County Cancer Center at Door County Memorial Hospital
Sturgeon Bay, Wisconsin, United States, 54235-1495
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States, 53188
Canada, Alberta
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1Y 4K7
Cancer Care Program at Thunder Bay Regional Health Sciences
Thunder Bay, Ontario, Canada, P7B 6V4
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada, H2W 1S6
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Sponsors and Collaborators
Radiation Therapy Oncology Group
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
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
  More Information

Additional Information:
Publications:
Armstrong 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.
Wang M, Dignam J, Won M, et al.: Variation over time and interdependence between disease progression and death among patients with glioblastoma (GBM) on RTOG 0525. [Abstract] J Clin Oncol 29 (Suppl 15): A-2017, 2011.
Aldape 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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00304031     History of Changes
Other Study ID Numbers: RTOG-0525, CDR0000465183, EORTC-26052, EORTC-22053, NCI-2009-00731
Study First Received: March 15, 2006
Results First Received: March 28, 2014
Last Updated: March 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Radiation Therapy Oncology Group:
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Glioblastoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014