Radiation Therapy (RT) and Temozolomide (TMZ) in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma
Brain and Central Nervous System Tumors
About this trial
This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
Eligibility Criteria
Inclusion criteria: 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. 6.1. 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: 14.1 Blood urea nitrogen (BUN) ≤ 25 mg/dl within 14 days prior to study registration 14.2 Creatinine ≤ 1.7 mg/dl within 14 days prior to study registration Adequate hepatic function, as defined below: 15.1 Bilirubin ≤ 2.0 mg/dl within 14 days prior to study registration 15.2 Alanine aminotransferase (ALT) ≤ 3 x normal range within 14 days prior to study registration 15.3 Aspartate aminotransferase (AST) ≤ 3 x normal range within 14 days prior to study registration Patients must sign a study-specific informed consent prior to study registration. If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the responsible family member. For females of child-bearing potential, negative serum pregnancy test within 72 hours prior to starting temozolomide. Women of childbearing potential and male participants must practice adequate Exclusion criteria: 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: 6.1. Unstable angina and/or congestive heart failure requiring hospitalization. 6.2. Transmural myocardial infarction within the last 6 months. 6.3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration. 6.4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration. 6.5. 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. 6.6. 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. 6.7. Major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy. 6.8. 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. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic. Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant due to study drug; Prior allergic reaction to temozolomide. Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study. No tissue provided for histopathologic central review and MGMT status. Tissue provided by stereotactic biopsy method.
Sites / Locations
- Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
- Arizona Oncology Services Foundation
- Mayo Clinic Scottsdale
- Arizona Oncology - Tucson
- Auburn Radiation Oncology
- Providence Saint Joseph Medical Center - Burbank
- Radiation Oncology Centers - Cameron Park
- Mercy Cancer Center at Mercy San Juan Medical Center
- City of Hope Comprehensive Cancer Center
- Kaiser Permanente Medical Center - Los Angeles
- Radiation Oncology Center - Roseville
- Radiological Associates of Sacramento Medical Group, Incorporated
- Mercy General Hospital
- UCSF Helen Diller Family Comprehensive Cancer Center
- Solano Radiation Oncology Center
- Penrose Cancer Center at Penrose Hospital
- Poudre Valley Radiation Oncology
- Yale Cancer Center
- Tunnell Cancer Center at Beebe Medical Center
- CCOP - Christiana Care Health Services
- Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
- University of Florida Shands Cancer Center
- Integrated Community Oncology Network
- Baptist Cancer Institute - Jacksonville
- Integrated Community Oncology Network at Southside Cancer Center
- Mayo Clinic - Jacksonville
- Baptist Medical Center South
- Baptist-South Miami Regional Cancer Program
- Integrated Community Oncology Network - Orange Park
- Florida Cancer Center - Palatka
- Flagler Cancer Center
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
- Piedmont Hospital
- John B. Amos Cancer Center
- Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
- Northwest Community Hospital
- Rush-Copley Cancer Care Center
- St. Joseph Medical Center
- Graham Hospital
- Memorial Hospital
- John H. Stroger, Jr. Hospital of Cook County
- University of Chicago Cancer Research Center
- Eureka Community Hospital
- Galesburg Clinic, PC
- Galesburg Cottage Hospital
- InterCommunity Cancer Center of Western Illinois
- Mason District Hospital
- Hopedale Medical Complex
- Joliet Oncology-Hematology Associates, Limited - West
- McDonough District Hospital
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- BroMenn Regional Medical Center
- Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Proctor Hospital
- OSF St. Francis Medical Center
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- Illinois Valley Community Hospital
- Perry Memorial Hospital
- St. Margaret's Hospital
- Valley Cancer Center
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- Elkhart General Hospital
- Radiation Oncology Associates Southwest
- Parkview Regional Cancer Center at Parkview Health
- Central Indiana Cancer Centers - East
- Howard Community Hospital
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- Saint Anthony Memorial Health Centers
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- Saint Joseph Regional Medical Center
- South Bend Clinic
- McFarland Clinic, PC
- Mercy Capitol Hospital
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Mercy Cancer Center at Mercy Medical Center - North Iowa
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas, PA - Kingman
- Southwest Medical Center
- Cancer Center of Kansas, PA - Newton
- Menorah Medical Center
- Kansas City Cancer Centers - Southwest
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Shawnee Mission Medical Center
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Wesley Medical Center
- Cancer Center of Kansas, PA - Winfield
- DeCesaris Cancer Institute at Anne Arundel Medical Center
- St. Agnes Hospital Cancer Center
- Union Hospital Cancer Program at Union Hospital
- Hickman Cancer Center at Bixby Medical Center
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Josephine Ford Cancer Center at Henry Ford Hospital
- Green Bay Oncology, Limited - Escanaba
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Dickinson County Healthcare System
- Foote Memorial Hospital
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Haematology-Oncology Associates of Ohio and Michigan, PC
- Sparrow Regional Cancer Center
- St. Mary Mercy Hospital
- Community Cancer Center of Monroe
- Mercy Memorial Hospital - Monroe
- St. Joseph Mercy Oakland
- Mercy Regional Cancer Center at Mercy Hospital
- William Beaumont Hospital - Royal Oak Campus
- Seton Cancer Institute at Saint Mary's - Saginaw
- Lakeland Regional Cancer Care Center - St. Joseph
- Providence Cancer Institute at Providence Hospital - Southfield Campus
- St. John Macomb Hospital
- MeritCare Bemidji
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Minnesota Oncology Hematology, PA - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
- Mayo Clinic Cancer Center
- CentraCare Clinic - River Campus
- Coborn Cancer Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- United Hospital
- Ridgeview Medical Center
- Minnesota Oncology Hematology, PA - Woodbury
- Independence Regional Health Center
- St. John's Regional Medical Center
- Truman Medical Center - Hospital Hill
- Saint Luke's Cancer Institute at Saint Luke's Hospital
- St. Joseph Medical Center
- North Kansas City Hospital
- Parvin Radiation Oncology
- CCOP - Kansas City
- Kansas City Cancer Centers - South
- Research Medical Center
- Liberty Hospital
- Heartland Regional Medical Center
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare Cancer Care Services
- Billings Clinic - Downtown
- St. James Healthcare Cancer Care
- Great Falls Clinic - Main Facility
- Northern Montana Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology at KRMC
- Kalispell Regional Medical Center
- Community Medical Center
- Guardian Oncology and Center for Wellness
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Good Samaritan Cancer Center at Good Samaritan Hospital
- Cancer Resource Center - Lincoln
- CCOP - Missouri Valley Cancer Consortium
- Methodist Estabrook Cancer Center
- Immanuel Medical Center
- Alegant Health Cancer Center at Bergan Mercy Medical Center
- Creighton University Medical Center
- University Medical Center of Southern Nevada
- CCOP - Nevada Cancer Research Foundation
- Dartmouth - Hitchcock Concord
- Kingsbury Center for Cancer Care at Cheshire Medical Center
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- St. Barnabas Medical Center Cancer Center
- Frederick R. and Betty M. Smith Cancer Treatment Center
- Cancer Institute of New Jersey at Cooper - Voorhees
- New York Methodist Hospital
- Monter Cancer Center of the North Shore-LIJ Health System
- CCOP - North Shore University Hospital
- Don Monti Comprehensive Cancer Center at North Shore University Hospital
- Long Island Jewish Medical Center
- Memorial Sloan-Kettering Cancer Center
- Hudson Valley Oncology Associates
- Lipson Cancer and Blood Center at Rochester General Hospital
- Mission Hospitals - Memorial Campus
- Wayne Memorial Hospital, Incorporated
- Wayne Radiation Oncology
- Rutherford Hospital
- Wilmed Radiation Oncology Services
- CCOP - MeritCare Hospital
- MeritCare Broadway
- McDowell Cancer Center at Akron General Medical Center
- Summa Center for Cancer Care at Akron City Hospital
- Mary Rutan Hospital
- Wood County Oncology Center
- Aultman Cancer Center at Aultman Hospital
- Adena Regional Medical Center
- Cleveland Clinic Cancer Center at Fairview Hospital
- Cleveland Clinic Taussig Cancer Center
- Riverside Methodist Hospital Cancer Care
- CCOP - Columbus
- Grant Medical Center Cancer Care
- Mount Carmel Health - West Hospital
- Doctors Hospital at Ohio Health
- Grady Memorial Hospital
- Cleveland Clinic Cancer Center
- Fairfield Medical Center
- Lima Memorial Hospital
- Strecker Cancer Center at Marietta Memorial Hospital
- Northwest Ohio Oncology Center
- St. Luke's Hospital
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
- St. Charles Mercy Hospital
- Toledo Clinic - Oregon
- Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
- North Coast Cancer Care, Incorporated
- Mercy Medical Center
- Community Hospital of Springfield and Clark County
- Flower Hospital Cancer Center
- Mercy Hospital of Tiffin
- Toledo Hospital
- St. Vincent Mercy Medical Center
- Medical University of Ohio Cancer Center
- CCOP - Toledo Community Hospital
- Toledo Clinic, Incorporated - Main Clinic
- Fulton County Health Center
- Mount Carmel St. Ann's Cancer Center
- Cancer Treatment Center
- Genesis - Good Samaritan Hospital
- Oklahoma University Cancer Institute
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Willamette Valley Cancer Center - Eugene
- Legacy Mount Hood Medical Center
- Providence Milwaukie Hospital
- Legacy Good Samaritan Hospital & Comprehensive Cancer Center
- Providence Cancer Center at Providence Portland Medical Center
- Adventist Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Legacy Emanuel Hospital and Health Center and Children's Hospital
- Salem Hospital Regional Cancer Care Services
- Legacy Meridian Park Hospital
- Rosenfeld Cancer Center at Abington Memorial Hospital
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
- Bryn Mawr Hospital
- Geisinger Cancer Institute at Geisinger Health
- Northeast Radiation Oncology Center
- Dale and Frances Hughes Cancer Center at Pocono Medical Center
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Riddle Memorial Hospital Cancer Center
- Upper Delaware Valley Cancer Center
- Intercommunity Cancer Center
- Alle-Kiski Medical Center
- Cancer Center of Paoli Memorial Hospital
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Fox Chase Cancer Center - Philadelphia
- Frankford Hospital Cancer Center - Torresdale Campus
- Allegheny Cancer Center at Allegheny General Hospital
- McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
- Somerset Oncology Center
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- CCOP - Main Line Health
- Lankenau Cancer Center at Lankenau Hospital
- AnMed Cancer Center
- Hollings Cancer Center at Medical University of South Carolina
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Rapid City Regional Hospital
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sanford Cancer Center at Sanford USD Medical Center
- Thompson Cancer Survival Center West
- Thompson Cancer Survival Center
- Thompson Cancer Survival Center at Methodist
- Medical City Dallas Hospital
- Texas Oncology, PA at Texas Cancer Center Dallas Southwest
- Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
- M. D. Anderson Cancer Center at University of Texas
- Joe Arrington Cancer Research and Treatment Center
- Texas Oncology, PA at Texas Cancer Center - Sherman
- Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
- American Fork Hospital
- Sandra L. Maxwell Cancer Center
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
- Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
- Utah Valley Regional Medical Center - Provo
- Dixie Regional Medical Center - East Campus
- LDS Hospital
- Utah Cancer Specialists at UCS Cancer Center
- Huntsman Cancer Institute at University of Utah
- Fletcher Allen Health Care - University Health Center Campus
- Norris Cotton Cancer Center - North
- Fredericksburg Oncology, Incorporated
- Sentara Cancer Institute at Sentara Norfolk General Hospital
- Virginia Commonwealth University Massey Cancer Center
- St. Joseph Cancer Center
- St. Francis Hospital
- Cascade Cancer Center at Evergreen Hospital Medical Center
- CCOP - Virginia Mason Research Center
- University Cancer Center at University of Washington Medical Center
- Southwest Washington Medical Center Cancer Center
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Theda Care Cancer Institute
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- Gundersen Lutheran Center for Cancer and Blood
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
- Bay Area Cancer Care Center at Bay Area Medical Center
- Community Memorial Hospital Cancer Care Center
- Regional Cancer Center at Oconomowoc Memorial Hospital
- Green Bay Oncology, Limited - Oconto Falls
- Door County Cancer Center at Door County Memorial Hospital
- Green Bay Oncology, Limited - Sturgeon Bay
- Waukesha Memorial Hospital Regional Cancer Center
- Tom Baker Cancer Centre - Calgary
- CancerCare Manitoba
- Saint John Regional Hospital
- Margaret and Charles Juravinski Cancer Centre
- Ottawa Hospital Regional Cancer Centre - General Campus
- Cancer Care Program at Thunder Bay Regional Health Sciences
- Princess Margaret Hospital
- McGill Cancer Centre at McGill University
- Centre Hospitalier Universitaire de Quebec
- Allan Blair Cancer Centre at Pasqua Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Other
Conventional adjuvant TMZ
Dose-dense adjuvant TMZ
No adjuvant TMZ (not randomized )
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.
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.
Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Not randomized to either adjuvant TMZ arm.