Spots Global Cancer Trial Database for Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery
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Trial Identification
Brief Title: Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery
Official Title: A Randomized Phase II Study of Systemic Chemotherapy With or Without HAI FUDR/Dexamethasone in Patients With Unresectable Intrahepatic Cholangiocarcinoma
Study ID: NCT04891289
Conditions
Study Description
Brief Summary: This study will compare the safety and effects of HAI floxuridine and dexamethasone combined with the standard chemotherapy drugs gemcitabine and oxaliplatin (GemOx) with those of GemOx alone in people with untreated cholangiocarcinoma that cannot be removed with surgery. The researchers want to find out whether the study treatment works better than the standard chemotherapy to delay progression of disease. For the study treatment to be considered better than the standard treatment, the study treatment should increase the time until progression of disease by an average of 3 months, compared with the usual approach.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
National Heart, Lung, and Blood Institute (NIH) (Data Collection Only), Bethesda, Maryland, United States
Washington University (Data Collection Only), Saint Louis, Missouri, United States
Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities, Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth - Limited Protocol Activities, Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen - Limited Protocol Activities, Montvale, New Jersey, United States
Memorial Sloan Kettering Commack - Limited Protocol Activities, Commack, New York, United States
Memorial Sloan Kettering Westchester - Limited Protocol Activities, Harrison, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Memorial Sloan Kettering Nassau - Limited Protocol Activities, Uniondale, New York, United States
Duke University (Data Collection Only), Durham, North Carolina, United States
Contact Details
Name: Andrea Cercek, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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