Spots Global Cancer Trial Database for SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma
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Trial Identification
Brief Title: SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma
Official Title: Prospective, Multicenter, Randomized, Controlled Study Evaluating SIR-Spheres Y-90 Resin Microspheres Preceding Cisplatin-gemcitabine (CIS-GEM) Chemotherapy Versus CIS-GEM Chemotherapy Alone as First-line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma
Study ID: NCT02807181
Conditions
Study Description
Brief Summary: The study will evaluate the benefit of applying Selective Internal Radiation Therapy (SIRT) using SIR-Spheres Y-90 resin microspheres prior to receiving systemic chemotherapy treatment (cisplatin-gemcitabine, or CIS-GEM) in patients with unresectable intrahepatic cholangiocarcinoma. Half of the patients will be randomized to CIS-GEM chemotherapy plus SIRT, and half of the patients will be randomized to CIS-GEM alone.
Detailed Description: This clinical study is a prospective, multicenter, randomized, controlled study evaluating SIR-Spheres Y-90 resin microspheres followed by cisplatin-gemcitabine (CIS-GEM) chemotherapy vs. CIS-GEM chemotherapy alone as first-line treatment of patients with unresectable intrahepatic cholangiocarcinoma. Randomized patients will be followed until death, withdrawal of consent, or until end of study.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Providence Health Care, Spokane, Washington, United States
Macquarie University Hospital, North Ryde, New South Wales, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
Hopital Beaujon, Clichy, , France
CHU Dijon, Dijon, , France
CHU de Grenoble, Grenoble, , France
CHU Lyon - Hospital de la Croix-Rousse, Lyon, , France
Institut Paoli Calmettes, Marseille, , France
CHU Montpellier, Montpellier, , France
CHU Nice - Hopital l'Archet 2, Nice, , France
Hopital Haut-Leveque, Pessac Cedex, , France
CHU de Poitiers, Poitiers, , France
Centre Eugene Marquis Hospital de Jour, Rennes, , France
Hopital Paul Brousse, Villejuif, , France
U.O. Oncologia Medica 2 Universitaria, Pisa, , Italy
AMC Academic Medical Center, Amsterdam, , Netherlands
Hospital Clinic Barcelona, Barcelona, , Spain
Clinica Universitaria de Navarra, Pamplona, , Spain
Hammersmith Hospital Imperial College Healthcare NHS Trust, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Southampton General Hospital, Southampton, , United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust, Wirral, , United Kingdom
Contact Details
Name: Jordi Bruix, MD
Affiliation: Head of the Hepatic Oncology Unit, Hospital Clinic
Role: PRINCIPAL_INVESTIGATOR
Name: Harpreet Wasan, MD
Affiliation: Imperial College Healthcare Hammersmith Hospital
Role: PRINCIPAL_INVESTIGATOR
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