Spots Global Cancer Trial Database for Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
Official Title: A Phase III Randomized Trial Of The Role Of Whole Brain Radiation Therapy In Addition To Radiosurgery In The Management Of Patients With One To Three Cerebral Metastases
Study ID: NCT00030628
Conditions
Study Description
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known if radiosurgery is more effective with or without whole-brain radiation therapy in treating brain metastases. PURPOSE: Randomized phase III trial to compare the effectiveness of radiosurgery with or without whole-brain radiation therapy in treating patients who have brain metastases.
Detailed Description: OBJECTIVES: * Compare the overall survival of patients with 1 to 3 cerebral metastases treated with radiosurgery with or without whole brain radiotherapy. * Compare the time to CNS failure (brain) in patients treated with these regimens. * Compare the quality of life, duration of functional independence, and long-term neurocognitive status in patients treated with these regimens. * Compare the post-treatment toxic effects of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (60 and over vs under 60), extracranial disease (controlled for more than 3 months vs controlled for 3 months or less), and number of brain metastases (1 vs more than 1). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo radiosurgery. * Arm II: Patients undergo radiosurgery. Within 14 days, patients then undergo whole brain radiotherapy 5 days a week for 2.5 weeks. Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years. Patients are followed at weeks 6 and 12, every 3 months for 9 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 480 patients (240 per treatment arm) will be accrued for this study within 5 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States
Foundation for Cancer Research and Education, Phoenix, Arizona, United States
Mount Diablo Regional Cancer Center, Concord, California, United States
Sutter Cancer Center, Sacramento, California, United States
UCSF Comprehensive Cancer Center, San Francisco, California, United States
John Muir Comprehensive Cancer Center at John Muir Medical Center, Walnut Creek, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora, Colorado, United States
Yale Comprehensive Cancer Center, New Haven, Connecticut, United States
Shands Cancer Center at the University of Florida Health Science Center, Gainesville, Florida, United States
University of Illinois Medical Center, Chicago, Illinois, United States
Genesis Regional Cancer Center at Genesis Medical Center, Davenport, Iowa, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Health System, Detroit, Michigan, United States
Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis, Missouri, United States
John F. Kennedy Medical Center, Edison, New Jersey, United States
SUNY Upstate Medical University Hospital, Syracuse, New York, United States
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, United States
Carolina Neurosurgery and Spine Associates, Charlotte, North Carolina, United States
American College of Surgeons Oncology Group, Durham, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center - Shadyside Hospital, Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
UPMC St. Margaret, Pittsburgh, Pennsylvania, United States
Methodist Cancer Center at Methodist University Hospital, Memphis, Tennessee, United States
American Fork Hospital, American Fork, Utah, United States
Cancer Center at the University of Virginia, Charlottesville, Virginia, United States
Massey Cancer Center at Virginia Commonwealth University, Richmond, Virginia, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
Contact Details
Name: Anthony Asher, MD, FACS
Affiliation: Carolina Neurosurgery and Spine Associates
Role: STUDY_CHAIR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
