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RTOG 0119 Protocol Information

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A Randomized Phase II Study of A.M. And P.M. Melatonin for Brain Metastasis in RPA Class II Patients
Protocol Documents
Current Version Date: 11/5/2002
Principal Investigator: Lawrence Berk, M. D. Ph.D.
Primary Objective:

To determine if overall survival is improved and clinical deterioration (as measured by the Mini-Mental Status Exam) is decreased by the administration of morning (a.m.) or evening (p.m.) melatonin when combined with external irradiation in patients with brain metastasis.

Patient Population:

 

  • Brain metastases from histologically-documented solid tumors (except germ cell tumors)
  • RPA class II patients: Zubrod Performance status of 0-1 and any of the following: >/=65 years of age; extra-cranial metastases; or uncontrolled primary malignancy
  • Ineligible for or unwilling to enroll in current RTOG stereotactic radiosurgery trials
  • No previous radiation to the brain
  • No planned concurrent chemotherapy during the two weeks of whole brain irradiation (Concurrent chemotherapy after irradiation, in patients with known disease, is allowed.); prior chemotherapy is allowed if > 30 days prior to registration
  • Ability to participate in Mini-Mental Status Examination
  • Ability to swallow pills
  • Patients who are of reproductive age and/or who are sexually active must practice an effective method of birth control while on study.
  • Patients must sign a study-specific informed consent form prior to study entry.
Target Accrual: 128
Current Accrual: 130
Status: Terminated
Date: 2/19/2009
Participating Sites:
Adena Regional Medical Center Chillicothe OH
Alta Bates Hospital Comprehensive Cancer Center Berkeley CA
Arizona Oncology Services Foundation Scottsdale AZ
Baptist Cancer Institute Jacksonville FL
Baptist Health Lexington Lexington KY
Bay Area Tumor Institute Oakland CA
Bon Secours Saint Mary's Hospital Richmond VA
California Pacific Medical Center-Pacific Campus San Francisco CA
Cancer Care Center, Inc Salem OH
Cancer Treatment Center Wooster OH
Cape Cod Hospital Hyannis MA
Case Western Reserve University Cleveland OH
Centre Hospitalier de l`Universite de Montreal-Notre Dame Montreal Quebec
City of Hope Comprehensive Cancer Center Duarte CA
Cleveland Clinic Foundation Cleveland OH
Cleveland Clinic Foundation- Parma Parma OH
Columbus CCOP Columbus OH
Cottonwood Hospital Medical Center Murray UT
Dartmouth Hitchcock Medical Center Lebanon NH
Dayton CCOP Kettering OH
Dixie Medical Center Regional Cancer Center East St. George UT
Doctors Hospital Columbus OH
Don & Sybil Harrington Cancer Center Amarillo TX
East Bay Radiation Oncology Center Castro Valley CA
Finley Hospital Dubuque IA
Froedtert and the Medical College of Wisconsin Milwaukee WI
Grady Memorial Hospital Delaware OH
Grant Medical Center Columbus OH
Greenville Health System Cancer Institute-Eastside Greenville SC
Gulf Coast Cancer Treatment Center Panama City FL
Gundersen Lutheran Medical Center La Crosse WI
Harbin Clinic Rome GA
Hematology Oncology Associates of Central New York-East Syracuse East Syracuse NY
Hillcrest Hospital Cancer Center Mayfield Heights OH
Indiana University/Melvin and Bren Simon Cancer Center Indianapolis IN
John B Amos Cancer Center Columbus GA
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
Lehigh Valley Hospital-Cedar Crest Allentown PA
Liberty Hospital Liberty MO
Licking Memorial Hospital Newark OH
Loma Linda University Medical Center Loma Linda CA
Marietta Memorial Hospital Marietta OH
Mayo Clinic Rochester MN
Mayo Clinic in Arizona Scottsdale AZ
Mayo Clinic in Florida Jacksonville FL
McGill University Department of Oncology Montreal
McKay-Dee Hospital Center Ogden UT
McLaren Cancer Institute - Flint Flint MI
Mercy Hospital Pittsburgh PA
Methodist Cancer Center Omaha NE
Mills-Peninsula Medical Center San Mateo CA
Mobile Infirmary Medical Center Mobile AL
Monmouth Medical Center Long Branch NJ
Mount Carmel Health Center West Columbus OH
Mount Sinai Medical Center Miami Beach FL
Natalie Warren Bryant Cancer Center at Saint Francis Tulsa OK
Nevada Cancer Research Foundation CCOP Las Vegas NV
North Shore-LIJ Health System CCOP Manhasset NY
Northeast Radiation Oncology Center Dunmore PA
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield Springfield MO
Pocono Medical Center East Strousburg PA
Pomona Valley Hospital Medical Center Pomona CA
Radiation Oncology Associates of Albuquerque Albuquerque NM
Rapid City Regional Hospital Rapid City SD
Regional Hospital of Scranton Scranton PA
Richard L. Roudebush VA Medical Center Indianapolis IN
Riverside Methodist Hospital Columbus OH
Roswell Park Cancer Institute Buffalo NY
Saint Ann's Hospital Westerville OH
Saint John Medical Center Tulsa OK
Saint Mary's Hospital and Regional Medical Center Grand Junction CO
Saint Vincent Hospital Cancer Center Green Bay Green Bay WI
South Suburban Oncology Center Quincy MA
Southeast Cancer Control Consortium CCOP Winston Salem NC
Southwestern Vermont Medical Center Bennington VT
Springfield Regional Medical Center Springfield OH
State University of New York Downstate Medical Center Brooklyn NY
State University of New York Upstate Medical University Syracuse NY
Summa Akron City Hospital/Cooper Cancer Center Akron OH
Sutter Health Western Division Cancer Research Group Novato CA
Tallahassee Memorial HealthCare Tallahassee FL
Trinity Cancer Care Center Minot ND
UCHealth Memorial Hospital Central Colorado Springs CO
Union Hospital Terre Haute IN
University of California Davis Comprehensive Cancer Center Sacramento CA
University of Cincinnati/Barrett Cancer Center Cincinnati OH
University of Colorado Hospital Aurora CO
University of Florida Health Science Center - Gainesville Gainesville FL
University of Florida Health Science Center - Jacksonville Jacksonville FL
University of Kentucky/Markey Cancer Center Lexington KY
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami FL
University of Southern California Los Angeles CA
University of Texas Medical Branch Galveston TX
Upstate Carolina CCOP Spartanburg SC
Utah Valley Regional Medical Center Provo UT
Valley Medical Oncology Consultants Pleasanton CA
Wake Forest University Health Sciences Winston-Salem NC
Washington University School of Medicine St. Louis MO
West Penn Hospital Pittsburgh PA
Wheaton Franciscan Cancer Care-All Saints Racine WI
Updated: 4/8/2011

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