Search / Trial NCT00002545

Radiation Therapy Plus Chemotherapy in Treating Patients With Supratentorial Glioblastoma Multiforme

Launched by RADIATION THERAPY ONCOLOGY GROUP · Jul 16, 2004

Trial Information

Current as of December 07, 2024

Completed

Keywords

Adult Glioblastoma Adult Giant Cell Glioblastoma Adult Gliosarcoma

ClinConnect Summary

OBJECTIVES: I. Determine whether the use of radiosurgery (stereotactic external-beam irradiation) prior to conventional radiotherapy with carmustine (BCNU) improves overall survival compared to conventional radiotherapy plus BCNU alone in patients with supratentorial glioblastoma multiforme. II. Determine and compare the frequency and severity of toxicities associated with these regimens. III. Compare the effects of these two regimens on neurologic function and quality of life.

OUTLINE: Randomized study. Arm I: Radiotherapy plus Single-Agent Chemotherapy. Tumor irradiation using megavoltag...

Gender

ALL

Eligibility criteria

  • 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

Trial Officials

Luis Souhami, MD

Study Chair

McGill Cancer Centre at McGill University

About Radiation Therapy Oncology Group

The Radiation Therapy Oncology Group (RTOG) is a leading clinical trial sponsor dedicated to advancing the field of radiation oncology through rigorous research and collaboration. Established to improve patient outcomes, RTOG conducts multicenter clinical trials that evaluate innovative radiation treatment techniques, assess the efficacy of combined modality therapies, and enhance quality of life for cancer patients. Committed to scientific excellence, RTOG fosters partnerships among academic institutions, healthcare providers, and industry stakeholders, ensuring that findings translate into clinical practice to optimize cancer care and improve survival rates.

Locations

Marshfield, Wisconsin, United States

Cleveland, Ohio, United States

Milwaukee, Wisconsin, United States

Akron, Ohio, United States

Tucson, Arizona, United States

Buffalo, New York, United States

New York, New York, United States

Calgary, Alberta, Canada

Bronx, New York, United States

Houston, Texas, United States

Ann Arbor, Michigan, United States

New York, New York, United States

Rochester, Minnesota, United States

Birmingham, Alabama, United States

Los Angeles, California, United States

Los Angeles, California, United States

Denver, Colorado, United States

Washington, District Of Columbia, United States

Tampa, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Iowa City, Iowa, United States

Lexington, Kentucky, United States

Baltimore, Maryland, United States

Ann Arbor, Michigan, United States

Detroit, Michigan, United States

Albany, New York, United States

Brooklyn, New York, United States

Rochester, New York, United States

Chapel Hill, North Carolina, United States

Winston Salem, North Carolina, United States

Cleveland, Ohio, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Charleston, South Carolina, United States

Spartanburg, South Carolina, United States

Charlottesville, Virginia, United States

Milwaukee, Wisconsin, United States

Miami, Florida, United States

New Orleans, Louisiana, United States

Flint, Michigan, United States

Greenville, North Carolina, United States

Burlington, Vermont, United States

Ottawa, Ontario, Canada

Atlanta, Georgia, United States

Kansas City, Missouri, United States

Omaha, Nebraska, United States

Las Vegas, Nevada, United States

Memphis, Tennessee, United States

San Francisco, California, United States

Wilmington, Delaware, United States

Miami Beach, Florida, United States

Baltimore, Maryland, United States

Columbia, Missouri, United States

Lebanon, New Hampshire, United States

Manhasset, New York, United States

Winston Salem, North Carolina, United States

Memphis, Tennessee, United States

Urbana, Illinois, United States

Kalamazoo, Michigan, United States

Saint Louis Park, Minnesota, United States

East Orange, New Jersey, United States

Pittsburgh, Pennsylvania, United States

Knoxville, Tennessee, United States

Lansing, Michigan, United States

Nashville, Tennessee, United States

Orlando, Florida, United States

Maywood, Illinois, United States

New Orleans, Louisiana, United States

Boston, Massachusetts, United States

Toledo, Ohio, United States

Edmonton, , Canada

Saskatoon, , Canada

Birmingham, Alabama, United States

Huntsville, Alabama, United States

Mobile, Alabama, United States

Mobile, Alabama, United States

Montgomery, Alabama, United States

Tuscallosa, Alabama, United States

Anchorage, Alaska, United States

Phoenix, Arizona, United States

Burbank, California, United States

Concord, California, United States

Fresno, California, United States

Fresno, California, United States

Glendale, California, United States

Greenbrae, California, United States

Loma Linda, California, United States

Long Beach, California, United States

Los Angeles, California, United States

Los Angeles, California, United States

Martinez, California, United States

Oakland, California, United States

Pomona, California, United States

Redding, California, United States

Sacramento, California, United States

San Jose, California, United States

Santa Cruz, California, United States

Santa Rosa, California, United States

Stanford, California, United States

Travis Air Force Base, California, United States

Walnut Creek, California, United States

Colorado Springs, Colorado, United States

Bridgeport, Connecticut, United States

Norwalk, Connecticut, United States

Clearwater, Florida, United States

Daytona Beach, Florida, United States

Fort Myers, Florida, United States

Gainesville, Florida, United States

Melbourne, Florida, United States

Miami, Florida, United States

Orange Park, Florida, United States

Panama City, Florida, United States

Pensacola, Florida, United States

Saint Petersburg, Florida, United States

Sarasota, Florida, United States

Columbus, Georgia, United States

Rome, Georgia, United States

Valdosta, Georgia, United States

Arlington Heights, Illinois, United States

Chicago, Illinois, United States

Harvey, Illinois, United States

Park Ridge, Illinois, United States

Peoria, Illinois, United States

Springfield, Illinois, United States

Anderson, Indiana, United States

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

Muncie, Indiana, United States

South Bend, Indiana, United States

South Bend, Indiana, United States

Dubuque, Iowa, United States

Bowling Green, Kentucky, United States

Lexington, Kentucky, United States

Louisville, Kentucky, United States

Louisville, Kentucky, United States

Madisonville, Kentucky, United States

Paducah, Kentucky, United States

Baton Rouge, Louisiana, United States

Lafayette, Louisiana, United States

Metairie, Louisiana, United States

New Orleans, Louisiana, United States

Portland, Maine, United States

Annapolis, Maryland, United States

Baltimore, Maryland, United States

Baltimore, Maryland, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Hyannis, Massachusetts, United States

Jamaica Plain, Massachusetts, United States

Ann Arbor, Michigan, United States

Detroit, Michigan, United States

Flint, Michigan, United States

Marquette, Michigan, United States

Midland, Michigan, United States

Saginaw, Michigan, United States

Saint Louis, Missouri, United States

Saint Louis, Missouri, United States

Saint Louis, Missouri, United States

Springfield, Missouri, United States

Springfield, Missouri, United States

Billings, Montana, United States

Omaha, Nebraska, United States

Manchester, New Hampshire, United States

Edison, New Jersey, United States

Elizabeth, New Jersey, United States

Millville, New Jersey, United States

Mount Holly, New Jersey, United States

Newark, New Jersey, United States

Toms River, New Jersey, United States

Trenton, New Jersey, United States

Albuquerque, New Mexico, United States

Albany, New York, United States

Brooklyn, New York, United States

Clifton Springs, New York, United States

New York, New York, United States

Plattsburgh, New York, United States

Poughkeepsie, New York, United States

Rochester, New York, United States

Valhalla, New York, United States

Concord, North Carolina, United States

Hickory, North Carolina, United States

Fargo, North Dakota, United States

Minot, North Dakota, United States

Akron, Ohio, United States

Cincinnati, Ohio, United States

Columbus, Ohio, United States

Dayton, Ohio, United States

Kettering, Ohio, United States

Tulsa, Oklahoma, United States

Corvallis, Oregon, United States

Portland, Oregon, United States

Allentown, Pennsylvania, United States

Bethlehem, Pennsylvania, United States

Danville, Pennsylvania, United States

Darby, Pennsylvania, United States

Drexel Hill, Pennsylvania, United States

Hershey, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Reading, Pennsylvania, United States

Scranton, Pennsylvania, United States

Sellersville, Pennsylvania, United States

Wilkes Barre, Pennsylvania, United States

Wynnewood, Pennsylvania, United States

York, Pennsylvania, United States

Providence, Rhode Island, United States

Greenville, South Carolina, United States

Jackson, Tennessee, United States

Amarillo, Texas, United States

Beaumont, Texas, United States

Galveston, Texas, United States

Lackland Air Force Base, Texas, United States

Lubbock, Texas, United States

Pasadena, Texas, United States

Tyler, Texas, United States

Saint George, Utah, United States

Salt Lake City, Utah, United States

Bennington, Vermont, United States

Rutland, Vermont, United States

White River Junction, Vermont, United States

Charlottesville, Virginia, United States

Lynchburg, Virginia, United States

Portsmouth, Virginia, United States

Richmond, Virginia, United States

Seattle, Washington, United States

Seattle, Washington, United States

Spokane, Washington, United States

Yakima, Washington, United States

Wheeling, West Virginia, United States

Green Bay, Wisconsin, United States

La Crosse, Wisconsin, United States

Madison, Wisconsin, United States

Madison, Wisconsin, United States

Madison, Wisconsin, United States

Menomonee Falls, Wisconsin, United States

Milwaukee, Wisconsin, United States

Milwaukee, Wisconsin, United States

Milwaukee, Wisconsin, United States

Racine, Wisconsin, United States

Waukesha, Wisconsin, United States

Victoria, British Columbia, Canada

Moncton, New Brunswick, Canada

Saint John, New Brunswick, Canada

Halifax, Nova Scotia, Canada

Hamilton, Ontario, Canada

Kingston, Ontario, Canada

London, Ontario, Canada

Sudbury, Ontario, Canada

Thunder Bay, Ontario, Canada

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Montreal, Quebec, Canada

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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