Brain and Central Nervous System Tumors Clinical Trial
Official title:
A PHASE III TRIAL COMPARING THE USE OF RADIOSURGERY FOLLOWED BY CONVENTIONAL RADIOTHERAPY WITH BCNU TO CONVENTIONAL RADIOTHERAPY WITH BCNU FOR SUPRATENTORIAL GLIOBLASTOMA MULTIFORME
Verified date | August 2013 |
Source | Radiation Therapy Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Chemotherapy
uses different ways to stop tumor cells from dividing so they stop growing or die. Combining
radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy and
carmustine in treating patients who have supratentorial glioblastoma multiforme.
Status | Completed |
Enrollment | 200 |
Est. completion date | |
Est. primary completion date | December 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: Histopathologically confirmed supratentorial glioblastoma
multiforme or gliosarcoma Diagnosis by surgical biopsy or resection required The following
tumor types are specifically excluded: Astrocytoma with atypical or anaplastic features
Well differentiated astrocytomas Tumors originating in the brain stem Tumors located
within 10 mm of the optic chiasm Infratentorial tumors Multifocal malignant glioma
Recurrent malignant glioma Well circumscribed contrast-enhancing tumor on pre- and
postoperative contrast-enhanced CT or MRI with a maximum diameter (in any direction) of 40
mm required Tumors that do not enhance on postoperative CT or MRI excluded Concurrent
enrollment on RTOG-9308 encouraged PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 3 months Hematopoietic: ANC at least 1,500 Platelets at least 100,000 Hb at least 10 g/dl (may transfuse) Hepatic: Bilirubin no greater than 2.0 mg/dl SGOT or SGPT no greater than 2 x normal Renal: Creatinine no greater than 1.5 mg/dl BUN no greater than 25 mg/dl Pulmonary: Chest x-ray normal If abnormal or if there is a history of pulmonary disease, pulmonary function studies (including DLCO) must be at least 75% of predicted Other: Neurologic function status 0-3 No AIDS No major medical or psychiatric illness that would preclude protocol therapy or follow-up No second malignancy within 5 years except: Nonmelanomatous skin cancer In situ carcinoma of the uterine cervix PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the head and neck Surgery: No more than 5 weeks between surgery and initiation of treatment Recovery from surgery and any postoperative complications required |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Tom Baker Cancer Center - Calgary | Calgary | Alberta |
Canada | Cross Cancer Institute | Edmonton | Alberta |
Canada | Nova Scotia Cancer Centre | Halifax | Nova Scotia |
Canada | Cancer Care Ontario-Hamilton Regional Cancer Centre | Hamilton | Ontario |
Canada | Kingston Regional Cancer Centre | Kingston | Ontario |
Canada | Cancer Care Ontario-London Regional Cancer Centre | London | Ontario |
Canada | Doctor Leon Richard Oncology Centre | Moncton | New Brunswick |
Canada | Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec |
Canada | McGill University Department of Oncology | Montreal | Quebec |
Canada | Ottawa Regional Cancer Centre - Civic Campus | Ottawa | Ontario |
Canada | Saint John Regional Hospital | Saint John | New Brunswick |
Canada | Saskatoon Cancer Centre | Saskatoon | Saskatchewan |
Canada | Northeastern Ontario Regional Cancer Centre, Sudbury | Sudbury | Ontario |
Canada | Northwestern Ontario Regional Cancer Centre, Thunder Bay | Thunder Bay | Ontario |
Canada | Princess Margaret Hospital | Toronto | Ontario |
Canada | Toronto Sunnybrook Regional Cancer Centre | Toronto | Ontario |
Canada | British Columbia Cancer Agency - Vancouver Island Cancer Centre | Victoria | British Columbia |
United States | Akron City Hospital | Akron | Ohio |
United States | Akron General Medical Center | Akron | Ohio |
United States | Cancer Center of Albany Medical Center | Albany | New York |
United States | Veterans Affairs Medical Center - Albany | Albany | New York |
United States | Saint Joseph Medical Center | Albuquerque | New Mexico |
United States | Lehigh Valley Hospital | Allentown | Pennsylvania |
United States | Harrington Cancer Center | Amarillo | Texas |
United States | Providence Cancer Therapy Center | Anchorage | Alaska |
United States | St. John's Medical Center | Anderson | Indiana |
United States | CCOP - Ann Arbor Regional | Ann Arbor | Michigan |
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | Veterans Affairs Medical Center - Ann Arbor | Ann Arbor | Michigan |
United States | Anne Arundel Oncology Center | Annapolis | Maryland |
United States | Northwest Community Hospital | Arlington Heights | Illinois |
United States | CCOP - Atlanta Regional | Atlanta | Georgia |
United States | Emory University Hospital - Atlanta | Atlanta | Georgia |
United States | Greater Baltimore Medical Center and Cancer Center | Baltimore | Maryland |
United States | Harbor Hospital Center | Baltimore | Maryland |
United States | Johns Hopkins Oncology Center | Baltimore | Maryland |
United States | Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland |
United States | Radiation Oncology Affiliates of Maryland, P.A. | Baltimore | Maryland |
United States | Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana |
United States | Julie and Ben Rogers Cancer Institute | Beaumont | Texas |
United States | CCOP - Southwestern Vermont Regional Cancer Center | Bennington | Vermont |
United States | St. Luke's Hospital Regional Cancer Center | Bethlehem | Pennsylvania |
United States | CCOP - Montana Cancer Consortium | Billings | Montana |
United States | University of Alabama Comprehensive Cancer Center | Birmingham | Alabama |
United States | Veterans Affairs Medical Center - Birmingham | Birmingham | Alabama |
United States | Joint Center for Radiation Therapy | Boston | Massachusetts |
United States | Massachusetts General Hospital Cancer Center | Boston | Massachusetts |
United States | Medical Center at Bowling Green | Bowling Green | Kentucky |
United States | Bridgeport Hospital | Bridgeport | Connecticut |
United States | Albert Einstein Comprehensive Cancer Center | Bronx | New York |
United States | New York Methodist Hospital | Brooklyn | New York |
United States | State University of New York Health Science Center at Brooklyn | Brooklyn | New York |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Providence Saint Joseph Medical Center - Burbank | Burbank | California |
United States | Vermont Cancer Center | Burlington | Vermont |
United States | Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Cancer Center, University of Virginia HSC | Charlottesville | Virginia |
United States | Martha Jefferson Hospital | Charlottesville | Virginia |
United States | Northwestern Memorial Hospital | Chicago | Illinois |
United States | University of Chicago Cancer Research Center | Chicago | Illinois |
United States | Christ Hospital | Cincinnati | Ohio |
United States | Lykes Center for Radiation Therapy | Clearwater | Florida |
United States | Cleveland Clinic Cancer Center | Cleveland | Ohio |
United States | Ireland Cancer Center | Cleveland | Ohio |
United States | University Hospitals of Cleveland | Cleveland | Ohio |
United States | Finger Lakes Radiation Oncology, P.C. | Clifton Springs | New York |
United States | Memorial Hospital Cancer Center | Colorado Springs | Colorado |
United States | Ellis Fischel Cancer Center - Columbia | Columbia | Missouri |
United States | Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio |
United States | CCOP - Columbus | Columbus | Ohio |
United States | Medical Center/John B. Amos Community Cancer Center | Columbus | Georgia |
United States | Mount Diablo Medical Center | Concord | California |
United States | Northeast Medical Center | Concord | North Carolina |
United States | Samaritan Regional Cancer Center | Corvallis | Oregon |
United States | Penn State Geisinger Medical Center | Danville | Pennsylvania |
United States | Mercy Catholic Medical Center, Mercy Fitzgerald Divison | Darby | Pennsylvania |
United States | Veterans Affairs Medical Center - Dayton | Dayton | Ohio |
United States | Halifax Medical Center | Daytona Beach | Florida |
United States | University of Colorado Cancer Center | Denver | Colorado |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Delaware County Memorial Hospital | Drexel Hill | Pennsylvania |
United States | Wendt Regional Cancer Center of Finley Hospital | Dubuque | Iowa |
United States | Veterans Affairs Medical Center - East Orange | East Orange | New Jersey |
United States | John F. Kennedy Medical Center | Edison | New Jersey |
United States | Trinitas Hosptial - Jersey Street Campus | Elizabeth | New Jersey |
United States | Meritcare Roger Maris Cancer Center | Fargo | North Dakota |
United States | Hurley Medical Center | Flint | Michigan |
United States | McLaren Regional Cancer Center | Flint | Michigan |
United States | Radiation Therapy Associates - Fort Myers | Fort Myers | Florida |
United States | California Cancer Center | Fresno | California |
United States | Saint Agnes Cancer Center | Fresno | California |
United States | University of Florida Health Science Center | Gainesville | Florida |
United States | University of Texas Medical Branch | Galveston | Texas |
United States | Glendale Memorial Hospital and Health Center | Glendale | California |
United States | St. Vincent Hospital | Green Bay | Wisconsin |
United States | Sutter Health Western Division Cancer Research Group | Greenbrae | California |
United States | CCOP - Greenville | Greenville | South Carolina |
United States | East Carolina University School of Medicine | Greenville | North Carolina |
United States | Ingalls Memorial Hospital | Harvey | Illinois |
United States | Penn State Geisinger Cancer Center | Hershey | Pennsylvania |
United States | Catawba Memorial Hospital | Hickory | North Carolina |
United States | University of Texas - MD Anderson Cancer Center | Houston | Texas |
United States | Huntsville Hospital System | Huntsville | Alabama |
United States | Cape Cod Hospital | Hyannis | Massachusetts |
United States | Clarion Health Partners Inc. | Indianapolis | Indiana |
United States | Community Hospitals of Indianapolis - Regional Cancer Center | Indianapolis | Indiana |
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
United States | Jackson-Madison County General Hospital | Jackson | Tennessee |
United States | Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain | Massachusetts |
United States | CCOP - Kalamazoo | Kalamazoo | Michigan |
United States | CCOP - Kansas City | Kansas City | Missouri |
United States | CCOP - Dayton | Kettering | Ohio |
United States | Baptist Regional Cancer Center - Knoxville | Knoxville | Tennessee |
United States | Gundersen Lutheran Medical Foundation | La Crosse | Wisconsin |
United States | Wilford Hall - 59th Medical Wing | Lackland Air Force Base | Texas |
United States | Romagosa Radiation Oncology Center | Lafayette | Louisiana |
United States | Sparrow Regional Cancer Center | Lansing | Michigan |
United States | CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada |
United States | Norris Cotton Cancer Center | Lebanon | New Hampshire |
United States | Albert B. Chandler Medical Center, University of Kentucky | Lexington | Kentucky |
United States | Veterans Affairs Medical Center - Lexington | Lexington | Kentucky |
United States | Loma Linda University Medical Center | Loma Linda | California |
United States | Veterans Affairs Medical Center - Long Beach | Long Beach | California |
United States | Beckman Research Institute, City of Hope | Los Angeles | California |
United States | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California |
United States | Kaiser Permanente Medical Center - Los Angeles | Los Angeles | California |
United States | USC/Norris Comprehensive Cancer Center | Los Angeles | California |
United States | James Graham Brown Cancer Center | Louisville | Kentucky |
United States | Louisville Radiation Oncology | Louisville | Kentucky |
United States | Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas |
United States | Virginia Baptist Hospital | Lynchburg | Virginia |
United States | Southern Wisconsin Radiotherapy Center | Madison | Wisconsin |
United States | University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin |
United States | Veterans Affairs Medical Center - Madison | Madison | Wisconsin |
United States | Merle M. Mahr Cancer Center | Madisonville | Kentucky |
United States | Elliot Regional Cancer Center | Manchester | New Hampshire |
United States | CCOP - North Shore University Hospital | Manhasset | New York |
United States | Marquette General Hospital | Marquette | Michigan |
United States | Marshfield Clinic | Marshfield | Wisconsin |
United States | Veterans Affairs Outpatient Clinic - Martinez | Martinez | California |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | Health First Holmes Regional Medical Center | Melbourne | Florida |
United States | CCOP - Baptist Cancer Institute | Memphis | Tennessee |
United States | University of Tennessee, Memphis Cancer Center | Memphis | Tennessee |
United States | Community Memorial Hospital | Menomonee Falls | Wisconsin |
United States | East Jefferson General Hospital | Metairie | Louisiana |
United States | Baptist Hospital of Miami | Miami | Florida |
United States | Sylvester Cancer Center, University of Miami | Miami | Florida |
United States | CCOP - Mount Sinai Medical Center | Miami Beach | Florida |
United States | MidMichigan Regional Medical Center | Midland | Michigan |
United States | South Jersey Hospital - Millville | Millville | New Jersey |
United States | Columbia Hospital | Milwaukee | Wisconsin |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | St. Joseph's Hospital | Milwaukee | Wisconsin |
United States | St. Luke's Medical Center | Milwaukee | Wisconsin |
United States | Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee | Wisconsin |
United States | UNI-MED Medical Center | Minot | North Dakota |
United States | MBCCOP - University of South Alabama | Mobile | Alabama |
United States | Urology Associates - Mobile AL | Mobile | Alabama |
United States | Alabama Oncology, LLC | Montgomery | Alabama |
United States | Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County | Mount Holly | New Jersey |
United States | Ball Memorial Hospital | Muncie | Indiana |
United States | Vanderbilt Cancer Center | Nashville | Tennessee |
United States | CCOP - Ochsner | New Orleans | Louisiana |
United States | MBCCOP - LSU Medical Center | New Orleans | Louisiana |
United States | Tulane University School of Medicine | New Orleans | Louisiana |
United States | Beth Israel Medical Center | New York | New York |
United States | Kaplan Cancer Center | New York | New York |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | Newark Beth Israel Medical Center | Newark | New Jersey |
United States | Whittingham Cancer Center | Norwalk | Connecticut |
United States | CCOP - Bay Area Tumor Institute | Oakland | California |
United States | CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska |
United States | Methodist Cancer Center - Omaha | Omaha | Nebraska |
United States | Florida Radiation Oncology Group | Orange Park | Florida |
United States | MD Anderson Cancer Center Orlando | Orlando | Florida |
United States | Western Baptist Hospital | Paducah | Kentucky |
United States | Gulf Coast Cancer Treatment Center | Panama City | Florida |
United States | Lutheran General Cancer Care Center | Park Ridge | Illinois |
United States | Bayshore Medical Center | Pasadena | Texas |
United States | West Florida Cancer Institute - Pensacola | Pensacola | Florida |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
United States | Albert Einstein Cancer Center | Philadelphia | Pennsylvania |
United States | Allegheny University Hospitals- Hahnemann | Philadelphia | Pennsylvania |
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
United States | Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania |
United States | University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania |
United States | Veterans Affairs Medical Center - Philadelphia | Philadelphia | Pennsylvania |
United States | St. Joseph's Hospital and Medical Center | Phoenix | Arizona |
United States | Mercy Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
United States | University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania |
United States | Western Pennsylvania Hospital | Pittsburgh | Pennsylvania |
United States | Champlain Valley Physicians Hospital Medical Center | Plattsburgh | New York |
United States | Cancer Care Center | Pomona | California |
United States | CCOP - Columbia River Program | Portland | Oregon |
United States | Maine Medical Center | Portland | Maine |
United States | Naval Medical Center, Portsmouth | Portsmouth | Virginia |
United States | Vassar Brothers Hospital | Poughkeepsie | New York |
United States | Roger Williams Medical Center/BUSM | Providence | Rhode Island |
United States | Southeastern Wisconsin Regional Cancer Center | Racine | Wisconsin |
United States | Reading Hospital and Medical Center | Reading | Pennsylvania |
United States | Mercy Medical Center - Redding | Redding | California |
United States | Massey Cancer Center | Richmond | Virginia |
United States | Genesee Hospital - Rochester | Rochester | New York |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | University of Rochester Cancer Center | Rochester | New York |
United States | InterCommunity Cancer Center at Rome | Rome | Georgia |
United States | Green Mountain Oncology Group | Rutland | Vermont |
United States | Radiation Oncology Center - Sacramento | Sacramento | California |
United States | St. Mary's Medical Center | Saginaw | Michigan |
United States | Dixie Regional Medical Center | Saint George | Utah |
United States | Mallinckrodt Institute of Radiology | Saint Louis | Missouri |
United States | St. Louis University Health Sciences Center | Saint Louis | Missouri |
United States | Veterans Affairs Medical Center - Saint Louis | Saint Louis | Missouri |
United States | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota |
United States | Bayfront Medical Center | Saint Petersburg | Florida |
United States | LDS Hospital | Salt Lake City | Utah |
United States | UCSF Cancer Center and Cancer Research Institute | San Francisco | California |
United States | O'Connor Hospital | San Jose | California |
United States | Santa Cruz Radiation Oncology Medical Group, Inc. | Santa Cruz | California |
United States | CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California |
United States | Sarasota Radiation and Medical Oncology Center | Sarasota | Florida |
United States | Mercy Hospital Cancer Center - Scranton | Scranton | Pennsylvania |
United States | Swedish Cancer Institute | Seattle | Washington |
United States | Virginia Mason Medical Center | Seattle | Washington |
United States | Grand View Hospital | Sellersville | Pennsylvania |
United States | Memorial Hospital of South Bend | South Bend | Indiana |
United States | St. Joseph's Radiation Oncology Center | South Bend | Indiana |
United States | CCOP - Upstate Carolina | Spartanburg | South Carolina |
United States | Deaconess Medical Center | Spokane | Washington |
United States | Cancer Research for the Ozarks | Springfield | Missouri |
United States | CCOP - Cancer Research for the Ozarks | Springfield | Missouri |
United States | CCOP - Central Illinois | Springfield | Illinois |
United States | Stanford University | Stanford | California |
United States | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
United States | CCOP - Toledo Community Hospital Oncology Program | Toledo | Ohio |
United States | Community Medical Center | Toms River | New Jersey |
United States | David Grant Medical Center | Travis Air Force Base | California |
United States | St. Francis Medical Center | Trenton | New Jersey |
United States | Arizona Cancer Center | Tucson | Arizona |
United States | St. John Medical Center | Tulsa | Oklahoma |
United States | Radiation Oncology Associates of West Alabama | Tuscallosa | Alabama |
United States | East Texas Medical Center - Cancer Institute | Tyler | Texas |
United States | CCOP - Carle Cancer Center | Urbana | Illinois |
United States | South Georgia Medical Center | Valdosta | Georgia |
United States | New York Medical College | Valhalla | New York |
United States | Radiation Oncology Center - Walnut Creek | Walnut Creek | California |
United States | Walter Reed Army Medical Center | Washington | District of Columbia |
United States | Waukesha Memorial Hospital | Waukesha | Wisconsin |
United States | Schiffler Oncology Center | Wheeling | West Virginia |
United States | Veterans Affairs Medical Center - White River Junction | White River Junction | Vermont |
United States | Wilkes Barre General Hospital | Wilkes-Barre | Pennsylvania |
United States | CCOP - Christiana Care Health Services | Wilmington | Delaware |
United States | CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina |
United States | Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina |
United States | CCOP - MainLine Health | Wynnewood | Pennsylvania |
United States | Yakima Valley Memorial Hospital | Yakima | Washington |
United States | York Hospital | York | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Radiation Therapy Oncology Group | National Cancer Institute (NCI) |
United States, Canada,
Anker CJ, Hymas RV, Hazard LJ, Boucher KM, Jensen RL, Shrieve DC. Stereotactic radiosurgery eligibility and selection bias in the treatment of glioblastoma multiforme. J Neurooncol. 2010 Jun;98(2):253-63. doi: 10.1007/s11060-010-0176-y. Epub 2010 Apr 10. — View Citation
Chakravarti A, Seiferheld W, Tu X, Wang H, Zhang HZ, Ang KK, Hammond E, Curran W Jr, Mehta M. Immunohistochemically determined total epidermal growth factor receptor levels not of prognostic value in newly diagnosed glioblastoma multiforme: report from th — View Citation
Chinnaiyan P, Wang M, Rojiani AM, Tofilon PJ, Chakravarti A, Ang KK, Zhang HZ, Hammond E, Curran W Jr, Mehta MP. The prognostic value of nestin expression in newly diagnosed glioblastoma: report from the Radiation Therapy Oncology Group. Radiat Oncol. 2008 Sep 25;3:32. doi: 10.1186/1748-717X-3-32. — View Citation
Seiferheld W, Chakravarti A, Ang KK, et al.: Overexpression of the epidermal growth factor receptor (EGFR), as determined by EGFR immunostaining on tissue microarrays, fails to demonstrate prognostic value for patients with glioblastoma multiforme: a report from RTOG 7401, 7918, 8302, 8409, 9006, 9305, 9602, and 9806. [Abstract] Int J Radiat Oncol Biol Phys 54(2 suppl 1): A-166, 616, 2002.
Souhami L, Scott C, Brachman D, et al.: Randomized prospective comparison of stereotactic radiosurgery (SRS) followed by conventional radiotherapy (RT) with BCNU to RT with BCNU alone for selected patients with supratentorial glioblastoma multiforme (GBM)
Souhami L, Seiferheld W, Brachman D, Podgorsak EB, Werner-Wasik M, Lustig R, Schultz CJ, Sause W, Okunieff P, Buckner J, Zamorano L, Mehta MP, Curran WJ Jr. Randomized comparison of stereotactic radiosurgery followed by conventional radiotherapy with carm — View Citation
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