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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
164
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Implanted hepatic arterial infusion pump by surgical oncology, to deliver HAI therapy
National Heart, Lung, and Blood Institute (NIH) (Data Collection Only)
Bethesda, Maryland, United States
RECRUITINGWashington University (Data Collection Only)
St Louis, Missouri, United States
RECRUITINGMemorial Sloan Kettering Basking Ridge - Limited Protocol Activities
Basking Ridge, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Monmouth - Limited Protocol Activities
Middletown, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Bergen - Limited Protocol Activities
Montvale, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Commack - Limited Protocol Activities
Commack, New York, United States
RECRUITINGMemorial Sloan Kettering Westchester - Limited Protocol Activities
Harrison, New York, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGMemorial Sloan Kettering Nassau - Limited Protocol Activities
Uniondale, New York, United States
RECRUITINGDuke University (Data Collection Only)
Durham, North Carolina, United States
RECRUITING...and 1 more locations
assess progression-free survival (PFS)
will be done using RECIST (version 1.1).
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
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