Spots Global Cancer Trial Database for Radiation Therapy vs. Observation Following Gemcitabine and Cisplatin for Inoperable Localized Liver Cancer
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Trial Identification
Brief Title: Radiation Therapy vs. Observation Following Gemcitabine and Cisplatin for Inoperable Localized Liver Cancer
Official Title: Randomized Phase III Study of Focal Radiation Therapy for Unresectable, Localized Intrahepatic Cholangiocarcinoma
Study ID: NCT02200042
Interventions
Study Description
Brief Summary: This randomized phase III trial studies how well gemcitabine hydrochloride and cisplatin with or without radiation therapy work in treating patients with localized liver cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x rays to kill tumor cells. It is not yet known whether giving gemcitabine and cisplatin is more effective with or without radiation therapy in this patient population. Patients register to this study after receiving gemcitabine and cisplatin.
Detailed Description: PRIMARY OBJECTIVES: I. To evaluate the addition of liver-directed radiation therapy with respect to overall survival (OS) for patients with unresectable, localized intrahepatic cholangiocarcinoma. SECONDARY OBJECTIVES: I. To evaluate the addition of liver-directed radiation therapy with respect to local control for patients with unresectable, localized intrahepatic cholangiocarcinoma. II. To evaluate the addition of liver-directed radiation therapy with respect to adverse events for patients with unresectable, localized intrahepatic cholangiocarcinoma. III. To evaluate the addition of liver-directed radiation therapy with respect to regional control for patients with unresectable, localized intrahepatic cholangiocarcinoma. IV. To evaluate the addition of liver-directed radiation therapy with respect to distant metastases for patients with unresectable, localized intrahepatic cholangiocarcinoma. V. To evaluate the addition of liver-directed radiation therapy with respect to progression-free survival for patients with unresectable, localized intrahepatic cholangiocarcinoma. After completion of study treatment, patients are followed up every 3 months for 3 years then every 6 months for 2 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Sutter Medical Center Sacramento, Sacramento, California, United States
Emory University Hospital Midtown, Atlanta, Georgia, United States
Piedmont Hospital, Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
Queen's Medical Center, Honolulu, Hawaii, United States
Northwestern University, Chicago, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
OSF Saint Francis Medical Center, Peoria, Illinois, United States
Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Maryland Proton Treatment Center, Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Boston Medical Center, Boston, Massachusetts, United States
Lahey Hospital and Medical Center, Burlington, Massachusetts, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Missouri Baptist Medical Center, Saint Louis, Missouri, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Mount Sinai Hospital, New York, New York, United States
University of Rochester, Rochester, New York, United States
University of Cincinnati/Barrett Cancer Center, Cincinnati, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Legacy Good Samaritan Hospital and Medical Center, Portland, Oregon, United States
M D Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
University of Vermont Medical Center, Burlington, Vermont, United States
ProCure Proton Therapy Center-Seattle, Seattle, Washington, United States
University of Washington Medical Center, Seattle, Washington, United States
West Virginia University Healthcare, Morgantown, West Virginia, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
The Research Institute of the McGill University Health Centre (MUHC), Montreal, Quebec, Canada
Contact Details
Name: Theodore Hong
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR
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