Computer Planned Radiation Therapy Plus Chemotherapy in Treating Patients With Glioblastoma Multiforme

Phase I/II Radiation Dose Escalation Study Applying Conformal Radiation Therapy in Supratentorial Glioblastoma Multiforme

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Computer systems that allow doctors to create a 3-dimensional picture of the tumor in order to plan treatment may result in more effective radiation therapy. Drugs used in chemotherapy use 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: Phase I/II trial to study the effectiveness of radiation therapy that has been planned with a computer plus chemotherapy in treating patients who have glioblastoma multiforme.

Study Overview

• Status: Completed
• Conditions: Brain and Central Nervous System Tumors
• Intervention / Treatment: Radiation: radiation therapy; Drug: carmustine

Detailed Description

OBJECTIVES:

• Determine the feasibility and toxicity of escalating doses of conformal radiotherapy planned with 3-D treatment planning plus carmustine in patients with glioblastoma multiforme.
• Determine dose/volume and dose/anatomic characteristics that influence radiotherapy-induced CNS (central nervous system) toxicity.
• Evaluate local control, survival, and failure patterns of these patients treated with high doses of conformal radiotherapy to gross disease.
• Correlate changes on cross-sectional diagnostic MRI imaging studies to clinical or biologic endpoints.

OUTLINE: This is a dose-escalation study. Patients are stratified according to the planned target volume, i.e., gross residual tumor plus 3 mm (less than 75 cc vs at least 75 cc).

Patients undergo radiotherapy over 15-30 minutes daily 5 days a week for 6-8 weeks. After 46 Gy of radiotherapy have been administered, patients undergo radiotherapy field reduction and are accrued into one of four dose levels. (Dose level 1 closed to accrual 1/16/01) All patients receive at least 33 radiation treatments. Each patient is evaluated for acute dose-limiting toxicity for 90 days from start of therapy.

Patients also receive carmustine IV over 1-2 hours daily on days 1-3 for the first week of radiotherapy. Treatment repeats every 8 weeks for up to 6 courses.

Patients are followed every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 40 patients (20 per arm) will be accrued for this study within at least 5 months.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Center - Calgary
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Saint John Regional Hospital
  • Newfoundland and Labrador
    • St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
      • Newfoundland Cancer Treatment and Research Foundation
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Nova Scotia Cancer Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Cancer Care Ontario-Hamilton Regional Cancer Centre
    • Kingston, Ontario, Canada, K7L 5P9
      • Kingston Regional Cancer Centre
    • London, Ontario, Canada, N6A 4L6
      • Cancer Care Ontario-London Regional Cancer Centre
    • Ottawa, Ontario, Canada, K1H 1C4
      • Ottawa Regional Cancer Centre
    • Sudbury, Ontario, Canada, P3E 5J1
      • Northeastern Ontario Regional Cancer Centre, Sudbury
    • Thunder Bay, Ontario, Canada, P7A 7T1
      • Northwestern Ontario Regional Cancer Centre, Thunder Bay
    • Toronto, Ontario, Canada, M4N 3M5
      • Toronto Sunnybrook Regional Cancer Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital
  • Quebec
    • Fleurimont, Quebec, Canada, J1H 5N4
      • CHUS-Hopital Fleurimont
    • Montreal, Quebec, Canada, H2W 1S6
      • McGill University
    • Montreal, Quebec, Canada, H2L 4MI
      • Centre Hospitalier de l'Universite de Montreal
    • Quebec City, Quebec, Canada, G1R 2J6
      • Centre Hospitalier Universitaire de Quebec
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 7T1
      • Allan Blair Cancer Centre
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Saskatoon Cancer Centre
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-3300
      • University of Alabama at Birmingham Comprehensive Cancer Center
    • Huntsville, Alabama, United States, 35801
      • Comprehensive Cancer Institute of Huntsville
    • Huntsville, Alabama, United States, 35807
      • Huntsville Hospital System
    • Mobile, Alabama, United States, 36688
      • MBCCOP - Gulf Coast
    • Montgomery, Alabama, United States, 36106-3657
      • Alabama Oncology, LLC
    • Tuscaloosa, Alabama, United States, 35401
      • DCH Cancer Treatment Center
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Foundation for Cancer Research and Education
  • California
    • Concord, California, United States, 94524-4110
      • Mount Diablo Medical Center
    • Duarte, California, United States, 91010-3000
      • City of Hope Comprehensive Cancer Center
    • Fresno, California, United States, 93720
      • Saint Agnes Cancer Center
    • Fresno, California, United States, 93729-5100
      • California Cancer Center
    • Greenbrae, California, United States, 94904
      • Sutter Health Western Division Cancer Research Group
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
    • Long Beach, California, United States, 90822
      • Veterans Affairs Medical Center - Long Beach
    • Los Angeles, California, United States, 90033-0804
      • USC/Norris Comprehensive Cancer Center and Hospital
    • Los Angeles, California, United States, 90025-1781
      • Jonsson Comprehensive Cancer Center, UCLA
    • Oakland, California, United States, 94609-3305
      • CCOP - Bay Area Tumor Institute
    • Pasadena, California, United States, 91105
      • Huntington Cancer Center
    • Pomona, California, United States, 91767
      • Robert and Beverly Lewis Family Cancer Care Center
    • Sacramento, California, United States, 95816
      • Radiation Oncology Center - Sacramento
    • San Diego, California, United States, 92101
      • Radiation Medical Group, Incorporated
    • San Francisco, California, United States, 94143-0128
      • UCSF Comprehensive Cancer Center
    • San Jose, California, United States, 95128
      • O'Connor Hospital
    • Santa Rosa, California, United States, 95403
      • CCOP - Santa Rosa Memorial Hospital
    • Travis Air Force Base, California, United States, 94535
      • David Grant Medical Center
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Memorial Hospital Cancer Center
    • Denver, Colorado, United States, 80010
      • University of Colorado Cancer Center
    • Denver, Colorado, United States, 80224
      • CCOP - Colorado Cancer Research Program, Incorporated
    • Grand Junction, Colorado, United States, 81502-1628
      • Saint Mary's Hospital and Medical Center
  • Delaware
    • Newark, Delaware, United States, 19713
      • CCOP - Christiana Care Health Services
  • Florida
    • Gainesville, Florida, United States, 32610-0385
      • University of Florida Health Science Center
    • Jacksonville, Florida, United States, 32207
      • Florida Radiation Oncology Group
    • Melbourne, Florida, United States, 32901-3276
      • Holmes Regional Medical Center
    • Miami, Florida, United States, 33136
      • Sylvester Cancer Center, University of Miami
    • Miami, Florida, United States, 33125
      • Veterans Affairs Medical Center - Miami
    • Miami, Florida, United States, 33256-2110
      • Baptist Hospital of Miami
    • Miami Beach, Florida, United States, 33140
      • CCOP - Mount Sinai Medical Center
    • Orlando, Florida, United States, 32806-2134
      • MD Anderson Cancer Center Orlando
    • Panama City, Florida, United States, 32405-4587
      • Gulf Coast Cancer Treatment Center
    • Panama City, Florida, United States, 32401
      • Bay Medical Center
    • Sarasota, Florida, United States, 34233
      • Sarasota Radiation and Medical Oncology Center
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial HealthCare
    • Tampa, Florida, United States, 33612-9497
      • H. Lee Moffitt Cancer Center and Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital - Atlanta
    • Atlanta, Georgia, United States, 30342-1701
      • CCOP - Atlanta Regional
    • Columbus, Georgia, United States, 31901
      • Medical Center/John B. Amos Community Cancer Center
    • Rome, Georgia, United States, 30165
      • Regional Radiation Oncology Center at Rome
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • MBCCOP - Hawaii
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Northwest Community Hospital
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Decatur, Illinois, United States, 62526
      • CCOP - Central Illinois
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hospital
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
    • Park Ridge, Illinois, United States, 60068
      • Lutheran General Cancer Care Center
    • Peoria, Illinois, United States, 61636
      • Methodist Medical Center of Illinois
  • Indiana
    • Anderson, Indiana, United States, 46016
      • St. John's Medical Center
    • Bloomington, Indiana, United States, 47402
      • Bloomington Hospital
    • Indianapolis, Indiana, United States, 46202
      • Veterans Affairs Medical Center - Indianapolis (Roudebush)
    • Indianapolis, Indiana, United States, 46206-1367
      • Clarian Health Partners Inc.
    • Indianapolis, Indiana, United States, 46219
      • Community Regional Cancer Care
    • Muncie, Indiana, United States, 47303-3499
      • Ball Memorial Hospital
    • South Bend, Indiana, United States, 46601
      • CCOP - Northern Indiana CR Consortium
  • Iowa
    • Dubuque, Iowa, United States, 52001
      • Wendt Regional Cancer Center of Finley Hospital
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0084
      • Albert B. Chandler Medical Center, University of Kentucky
    • Lexington, Kentucky, United States, 40503
      • Central Baptist Hospital
    • Lexington, Kentucky, United States, 40504
      • Cancer Center at Lexington Clinic
    • Louisville, Kentucky, United States, 40202
      • James Graham Brown Cancer Center
    • Louisville, Kentucky, United States, 40215
      • Louisville Radiation Oncology
    • Madisonville, Kentucky, United States, 42431
      • Merle M. Mahr Cancer Center
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Mary Bird Perkins Cancer Center
    • New Orleans, Louisiana, United States, 70121
      • CCOP - Ochsner
    • New Orleans, Louisiana, United States, 70112
      • MBCCOP - LSU Health Sciences Center
    • New Orleans, Louisiana, United States, 70112-2699
      • Tulane University School of Medicine
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Oncology Center
    • Baltimore, Maryland, United States, 21231-2410
      • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Baltimore, Maryland, United States, 21215
      • Sinai Hospital of Baltimore
    • Baltimore, Maryland, United States, 21201
      • Marlene and Stewart Greenebaum Cancer Center, University of Maryland
    • Baltimore, Maryland, United States, 21204
      • Greater Baltimore Medical Center and Cancer Center
    • Baltimore, Maryland, United States, 21215-1290
      • Harbor Hospital Center
    • Salisbury, Maryland, United States, 21801
      • Peninsula Regional Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Dana-Farber Cancer Institute
    • Hyannis, Massachusetts, United States, 02601
      • Cape Cod Hospital
    • Jamaica Plain, Massachusetts, United States, 02130
      • Veterans Affairs Medical Center - Boston (Jamaica Plain)
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • CCOP - Michigan Cancer Research Consortium
    • Ann Arbor, Michigan, United States, 48109-0010
      • University of Michigan Comprehensive Cancer Center
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48201-1379
      • Barbara Ann Karmanos Cancer Institute
    • Flint, Michigan, United States, 48503
      • Hurley Medical Center
    • Flint, Michigan, United States, 48532-3685
      • McLaren Regional Cancer Center
    • Kalamazoo, Michigan, United States, 49007-3731
      • CCOP - Kalamazoo
    • Marquette, Michigan, United States, 49855
      • Marquette General Hospital
    • Midland, Michigan, United States, 48670
      • MidMichigan Medical Center - Midland
    • Royal Oak, Michigan, United States, 48073-6769
      • CCOP - Beaumont
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
    • Troy, Michigan, United States, 48098
      • William Beaumont Hospital - Troy
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Cancer Center
    • Saint Louis Park, Minnesota, United States, 55416
      • CCOP - Metro-Minnesota
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Ellis Fischel Cancer Center - Columbia
    • Kansas City, Missouri, United States, 64131
      • CCOP - Kansas City
    • Saint Louis, Missouri, United States, 63110-0250
      • St. Louis University Health Sciences Center
    • Saint Louis, Missouri, United States, 63108
      • Mallinckrodt Institute of Radiology
    • Springfield, Missouri, United States, 65807
      • CCOP - Cancer Research for the Ozarks
    • Springfield, Missouri, United States, 65807
      • Cancer Research for the Ozarks
  • Montana
    • Billings, Montana, United States, 59101
      • CCOP - Montana Cancer Consortium
  • Nebraska
    • Omaha, Nebraska, United States, 68106
      • CCOP - Missouri Valley Cancer Consortium
    • Omaha, Nebraska, United States, 68114
      • Methodist Hospital Cancer Center - Omaha
    • Omaha, Nebraska, United States, 68198-7460
      • Nebraska Health System
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • CCOP - Southern Nevada Cancer Research Foundation
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756-0002
      • Norris Cotton Cancer Center
    • Manchester, New Hampshire, United States, 03103
      • Elliot Regional Cancer Center
  • New Jersey
    • East Orange, New Jersey, United States, 07019
      • Veterans Affairs Medical Center - East Orange
    • Edison, New Jersey, United States, 08818
      • John F. Kennedy Medical Center
    • Elizabeth, New Jersey, United States, 07201
      • Trinitas Hospital - Jersey Street Campus
    • Long Branch, New Jersey, United States, 07740-6395
      • Monmouth Medical Center
    • Millville, New Jersey, United States, 08332
      • South Jersey Regional Cancer Center
    • Mount Holly, New Jersey, United States, 08060
      • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
    • New Brunswick, New Jersey, United States, 38103-2807
      • Cancer Institute of New Jersey
    • Newark, New Jersey, United States, 07112
      • Newark Beth Israel Medical Center
    • Pomona, New Jersey, United States, 08240
      • Atlantic City Medical Center
    • Ridgewood, New Jersey, United States, 07450
      • Valley Hospital
    • Toms River, New Jersey, United States, 08755
      • Community Medical Center
    • Trenton, New Jersey, United States, 08629
      • St. Francis Medical Center
    • Warren, New Jersey, United States, 07059
      • Associated Radiologists, P.A.
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Radiation Oncology Associates of Albuquerque
  • New York
    • Albany, New York, United States, 12208
      • Cancer Center of Albany Medical Center
    • Brooklyn, New York, United States, 11203
      • State University of New York Health Science Center at Brooklyn
    • Brooklyn, New York, United States, 11215
      • New York Methodist Hospital
    • Buffalo, New York, United States, 14263-0001
      • Roswell Park Cancer Institute
    • Clifton Springs, New York, United States, 14432
      • Finger Lakes Radiation Oncology Center
    • Manhasset, New York, United States, 11030
      • CCOP - North Shore University Hospital
    • New York, New York, United States, 10032
      • Herbert Irving Comprehensive Cancer Center
    • Plattsburgh, New York, United States, 12901
      • Champlain Valley Physicians Hospital Medical Center
    • Poughkeepsie, New York, United States, 12601
      • Vassar Brothers Medical Center
    • Rochester, New York, United States, 14642
      • James P. Wilmot Cancer Center
    • Syracuse, New York, United States, 13217
      • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
    • Yonkers, New York, United States, 10701
      • Riverhill Radiation Oncology
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7295
      • Lineberger Comprehensive Cancer Center, UNC
    • Concord, North Carolina, United States, 28025
      • Northeast Medical Center
    • Greenville, North Carolina, United States, 27858-4354
      • East Carolina University School of Medicine
    • Winston-Salem, North Carolina, United States, 27104-4241
      • CCOP - Southeast Cancer Control Consortium
    • Winston-Salem, North Carolina, United States, 27157-1082
      • Comprehensive Cancer Center at Wake Forest University
  • North Dakota
    • Minot, North Dakota, United States, 58701
      • Trinity Cancer Care Center
  • Ohio
    • Akron, Ohio, United States, 44302
      • Akron General Medical Center
    • Akron, Ohio, United States, 44304
      • Akron City Hospital
    • Cincinnati, Ohio, United States, 45219
      • Christ Hospital
    • Cincinnati, Ohio, United States, 45267-0502
      • Barrett Cancer Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussig Cancer Center
    • Cleveland, Ohio, United States, 44106
      • University Hospitals of Cleveland
    • Cleveland, Ohio, United States, 44106-5065
      • Ireland Cancer Center
    • Columbus, Ohio, United States, 43210-1240
      • Arthur G. James Cancer Hospital - Ohio State University
    • Columbus, Ohio, United States, 43206
      • CCOP - Columbus
    • Dayton, Ohio, United States, 45429
      • CCOP - Dayton
    • Toledo, Ohio, United States, 43623-3456
      • CCOP - Toledo Community Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
    • Oklahoma City, Oklahoma, United States, 73101
      • St. Anthony Hospital
    • Tulsa, Oklahoma, United States, 74136
      • CCOP - Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • St. John Health System
  • Oregon
    • Portland, Oregon, United States, 97225
      • CCOP - Columbia River Oncology Program
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18105
      • LeHigh Valley Hospital
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's Hospital Cancer Center
    • Danville, Pennsylvania, United States, 17822-2001
      • Geisinger Medical Center
    • Darby, Pennsylvania, United States, 19023
      • Mercy Fitzgerald Hospital
    • Drexel Hill, Pennsylvania, United States, 19026
      • Delaware County Memorial Hospital
    • East Stroudsburg, Pennsylvania, United States, 18301
      • Pocono Cancer Center
    • Hershey, Pennsylvania, United States, 17033-0850
      • Milton S. Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19104-4283
      • Abramson Cancer Center of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Veterans Affairs Medical Center - Philadelphia
    • Philadelphia, Pennsylvania, United States, 19107-5541
      • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
    • Philadelphia, Pennsylvania, United States, 19141-3098
      • Albert Einstein Cancer Center
    • Pittsburgh, Pennsylvania, United States, 15224
      • Western Pennsylvania Hospital
    • Pittsburgh, Pennsylvania, United States, 15219
      • Mercy Hospital of Pittsburgh
    • Pittsburgh, Pennsylvania, United States, 15236
      • University of Pittsburgh Cancer Institute
    • Reading, Pennsylvania, United States, 19612-6052
      • Reading Hospital and Medical Center
    • Scranton, Pennsylvania, United States, 18501
      • Mercy Hospital Cancer Center - Scranton
    • Wilkes-Barre, Pennsylvania, United States, 18764
      • Wilkes Barre General Hospital
    • York, Pennsylvania, United States, 17403
      • York Cancer Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02908-4735
      • Roger Williams Medical Center/BUSM
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • CCOP - Greenville
    • Spartanburg, South Carolina, United States, 29303
      • CCOP - Upstate Carolina
  • South Dakota
    • Rapid City, South Dakota, United States, 57709
      • Rapid City Regional Hospital
  • Tennessee
    • Jackson, Tennessee, United States, 38301-3956
      • Jackson-Madison County General Hospital
    • Memphis, Tennessee, United States, 38103
      • University of Tennessee Cancer Institute
    • Nashville, Tennessee, United States, 37232-5671
      • Vanderbilt-Ingram Cancer Center
  • Texas
    • Amarillo, Texas, United States, 79106
      • Harrington Cancer Center
    • Galveston, Texas, United States, 77555-0209
      • University of Texas Medical Branch
    • Houston, Texas, United States, 77030-4009
      • University of Texas - MD Anderson Cancer Center
    • Lackland Air Force Base, Texas, United States, 78236-5300
      • Wilford Hall Medical Center
    • Lubbock, Texas, United States, 79410-1894
      • Joe Arrington Cancer Research and Treatment Center
    • Pasadena, Texas, United States, 77504
      • Bayshore Medical Center
  • Utah
    • Saint George, Utah, United States, 84770
      • Dixie Regional Medical Center
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Health Sciences Center
    • Salt Lake City, Utah, United States, 84143
      • Latter Day Saints Hospital
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Green Mountain Oncology Group
    • Burlington, Vermont, United States, 05405-0075
      • Vermont Cancer Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Cancer Center at the University of Virginia
    • Harrisonburg, Virginia, United States, 22801
      • RMH Regional Cancer Center
    • Portsmouth, Virginia, United States, 23708-2197
      • Naval Medical Center, Portsmouth
    • Richmond, Virginia, United States, 23226
      • Bon Secours - St. Mary's Hospital
    • Richmond, Virginia, United States, 23298-0058
      • Massey Cancer Center
  • Washington
    • Seattle, Washington, United States, 98111
      • Virginia Mason Medical Center
    • Spokane, Washington, United States, 99204
      • Deaconess Medical Center
    • Yakima, Washington, United States, 98902
      • Yakima Valley Memorial Hospital
  • West Virginia
    • Wheeling, West Virginia, United States, 26003
      • Schiffler Cancer Center
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • CCOP - St. Vincent Hospital Cancer Center, Green Bay
    • Green Bay, Wisconsin, United States, 54307-3508
      • St. Vincent Hospital
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Lutheran Medical Foundation
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Comprehensive Cancer Center
    • Madison, Wisconsin, United States, 53713
      • Southern Wisconsin Radiotherapy Center
    • Marshfield, Wisconsin, United States, 54449
      • Marshfield Clinic
    • Menomonee Falls, Wisconsin, United States, 53051
      • Community Memorial Hospital
    • Milwaukee, Wisconsin, United States, 53211
      • Columbia Hospital
    • Milwaukee, Wisconsin, United States, 53215
      • St. Luke's Medical Center
    • Milwaukee, Wisconsin, United States, 53295
      • Veterans Affairs Medical Center - Milwaukee (Zablocki)
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin Cancer Center
    • Racine, Wisconsin, United States, 53405
      • All Saints Cancer Center
    • Waukesha, Wisconsin, United States, 53188
      • Waukesha Memorial Hospital Regional Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS:

• Histologically confirmed glioblastoma multiforme with areas of necrosis as diagnosed by surgical biopsy or subtotal excision

  • Supratentorial tumor
• Gross measurable residual disease
• No well-differentiated or anaplastic astrocytoma, multifocal glioma, or recurrent glioblastoma multiforme
• Therapy must begin within 5 weeks after surgery but within 1 week after registration

• CT or MRI scan preoperatively and MRI postoperatively prior to initiation of radiotherapy

  • If undergoing a stereotactic-guided needle biopsy, not required to repeat MRI after procedure if the prebiopsy MRI is suitable for treatment planning
• Prior complete surgical resection of tumor allowed

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 9 g/dL

Hepatic:

• Bilirubin no greater than 2 mg/dL
• SGPT (serum glutamate pyruvate transaminase) or SGOT (serum glutamic oxaloacetic transaminase) no greater than 2 times normal

Renal:

• BUN (blood urea nitrogen) no greater than 30 mg/dL
• Creatinine no greater than 1.8 mg/dL

Pulmonary:

• Normal chest x-ray OR
• DLCO (carbon monoxide diffusing capacity) at least 60% predicted

Other:

• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other malignancy within the past 5 years except carcinoma in situ of the cervix or bladder, ductal carcinoma in situ of the breast, or nonmelanomatous skin cancer
• Neurologic functional status 0-3
• No major medical illness or psychiatric impairments that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior systemic chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy to head or neck

Surgery:

• See Disease Characteristics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: Radiation Therapy Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Jeff M. Michalski, MD, Washington University Siteman Cancer Center

Publications and helpful links

General Publications

• Corn BW, Wang M, Fox S, Michalski J, Purdy J, Simpson J, Kresl J, Curran WJ Jr, Diaz A, Mehta M, Movsas B. Health related quality of life and cognitive status in patients with glioblastoma multiforme receiving escalating doses of conformal three dimensional radiation on RTOG 98-03. J Neurooncol. 2009 Nov;95(2):247-257. doi: 10.1007/s11060-009-9923-3. Epub 2009 Jun 16.
• Tsien C, Moughan J, Michalski JM, Gilbert MR, Purdy J, Simpson J, Kresel JJ, Curran WJ, Diaz A, Mehta MP; Radiation Therapy Oncology Group Trial 98-03. Phase I three-dimensional conformal radiation dose escalation study in newly diagnosed glioblastoma: Radiation Therapy Oncology Group Trial 98-03. Int J Radiat Oncol Biol Phys. 2009 Mar 1;73(3):699-708. doi: 10.1016/j.ijrobp.2008.05.034. Epub 2008 Aug 23.
• 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 carmustine to conventional radiotherapy with carmustine for patients with glioblastoma multiforme: report of Radiation Therapy Oncology Group 93-05 protocol. Int J Radiat Oncol Biol Phys. 2004 Nov 1;60(3):853-60. doi: 10.1016/j.ijrobp.2004.04.011.

Study record dates

Study Major Dates

• Study Start: September 1, 1998
• Primary Completion (Actual): May 1, 2004

Study Registration Dates

• First Submitted: November 1, 1999
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): November 17, 2015
• Last Update Submitted That Met QC Criteria: November 14, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Nervous System Neoplasms; Central Nervous System Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Carmustine
• Other Study ID Numbers: RTOG-9803; CDR0000066432