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RTOG 0021 Protocol Information

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A Phase II Trial of Conventional Radiation Therapy plus High Dose Tamoxifen for the Treatment of Supratentorial Glioblastoma Multiforme (GBM)
Protocol Documents
Current Version Date: 1/21/2003
Principal Investigator: H. Ian Robins, M.D., Ph.D.
Primary Objective:

To determine if tamoxifen given orally on a daily basis starting at the time of conventional RT may improve the overall survival time of adults with newly diagnosed supratentorial glioblastoma.

Patient Population:

 

Histopathologically confirmed glioblastoma multiforme (with areas of necrosis); recurrent GBM is not eligible
Diagnosis must be made by surgical biopsy or excision
The tumor must be supratentorial in location
Patient must have recovered from the effects of surgery, or post-operative infection and other complications
Therapy must begin </= five weeks after surgery
Estimated survival of at least 8 weeks
KPS >/=70 (Zubrod 0 and 1)
A contrast-enhanced MRI or CT scan must be performed preoperatively and postoperatively prior to initiation of RT.
Absolute neutrophil count >/=1500, platelets >/=100,000, BUN </= 25, Creatinine 1.5, Bilirubin </= 2.0, Hgb >/=10 gm, SGPT or SGOT </= 2 x normal range
No metastases below the tentorium or beyond the cranial vault
No major medical illnesses or psychiatric impairments
No active connective tissue disorders or active thrombophlebitis
No malignancy (within the past five years) except non-melanomatous skin cancer or carcinoma in-situ of the cervix, no prior endometrial cancer or atypical endometrial hyperplasia.
No prior radiation therapy to head or neck area, chemotherapy or radiosensitizer.
No patients with Acquired Immune Deficiency (AIDS)
No pregnant or lactating women; tamoxifen is contraindicated in pregnancy
Signed study-specific consent form prior to registration
Target Accrual: 72
Current Accrual: 77
Status: Terminated
Date: 2/19/2009
Participating Sites:
Akron General Medical Center Akron OH
Arizona Oncology Services Foundation Scottsdale AZ
Baptist Cancer Institute Jacksonville FL
Baptist Hospital of East Tennessee Knoxville TN
Baptist Hospital of Miami Miami FL
Bay Medical Center Panama City FL
Cancer Care Center, Inc Salem OH
Cancer Treatment Center Wooster OH
Case Western Reserve University Cleveland OH
Christiana Care Health System-Christiana Hospital Newark DE
Columbia Saint Mary's Water Tower Medical Commons Milwaukee WI
Community Medical Center Toms River NJ
Cottonwood Hospital Medical Center Murray UT
Dixie Medical Center Regional Cancer Center East St. George UT
Einstein Medical Center Philadelphia Philadelphia PA
Elizabeth General Medical Center Elizabeth NJ
Finley Hospital Dubuque IA
Froedtert and the Medical College of Wisconsin Milwaukee WI
Froedtert Memorial Lutheran Hospital Milwaukee WI
Greater Baltimore Medical Center Baltimore MD
Gulf Coast Cancer Treatment Center Panama City FL
Gundersen Lutheran Medical Center La Crosse WI
Halifax Hospital ROC Daytona Beach FL
Harbin Clinic Rome GA
Indiana University Health Methodist Hospital Indianapolis IN
Inspira Medical Center Vineland Vineland NJ
John F Kennedy Medical Center Edison NJ
Kalamazoo CCOP-West Michigan Cancer Center Kalamazoo MI
Kansas City CCOP Prairie Village KS
LDS Hospital Salt Lake City UT
Liberty Hospital Liberty MO
Mary Bird Perkins Cancer Center Baton Rouge LA
McKay-Dee Hospital Center Ogden UT
Mercy Hospital Pittsburgh PA
Methodist Cancer Center Omaha NE
Methodist Medical Center of Illinois Peoria IL
Montefiore Medical Center - Moses Campus Bronx NY
Mount Sinai Medical Center Miami Beach FL
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima WA
Northern Indiana Cancer Research Consortium South Bend IN
Northwest Community Hospital Arlington Heights IL
Northwestern University Chicago IL
Peninsula Regional Medical Center Salisbury MD
Pomona Valley Hospital Medical Center Pomona CA
Radiological Associates of Sacramento Sacramento CA
Rapid City Regional Hospital Rapid City SD
Regional Hospital of Scranton Scranton PA
Saint Agnes Medical Center Fresno CA
Saint John Medical Center Tulsa OK
Saint Luke's University Hospital-Bethlehem Campus Bethlehem PA
Saint Vincent Hospital Cancer Center Green Bay Green Bay WI
Santa Rosa Memorial Hospital CCOP Santa Rosa CA
Scott and White Memorial Hospital Temple TX
Southeast Cancer Control Consortium CCOP Winston Salem NC
Southwestern Vermont Medical Center Bennington VT
Stanford Cancer Institute Palo Alto Palo Alto CA
State University of New York Downstate Medical Center Brooklyn NY
Summa Akron City Hospital/Cooper Cancer Center Akron OH
Tallahassee Memorial HealthCare Tallahassee FL
Trinity Cancer Care Center Minot ND
UCLA Medical Center Los Angeles CA
UF Cancer Center at Orlando Health Orlando FL
UHHS - Chagrin Highlands Orange Village OH
UHHS-Westlake Medical Center Westlake OH
Union Hospital Terre Haute IN
University of Utah Health Science Center Salt Lake City UT
University of Vermont Medical Center Burlington VT
University of Wisconsin Hospital and Clinics Madison WI
UP Health System Marquette Marquette MI
Utah Valley Regional Medical Center Provo UT
Virginia Mason CCOP Seattle WA
Virtua Memorial Mount Holly NJ
West Penn Hospital Pittsburgh PA
Wheaton Franciscan Cancer Care-All Saints Racine WI
Wheeling Hospital/Schiffler Cancer Center Wheeling WV
William Beaumont Hospital-Royal Oak Royal Oak MI
Wyoming Valley Health Care System - Hospital Wilkes-Barre PA
Updated: 4/7/2011

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