Treatment of patients with colorectal cancer having liver metastases is currently based on systemic chemotherapy. Triple therapy with 5FU, oxaliplatin and irinotecan intravenously was effective in terms of response and secondary resectability, however it is particularly toxic. Hepatic intra-arterial chemotherapy (HIA) has been the subject of several studies. It has shown good efficacy with oxaliplatin and FUDR. However, the procedure is difficult to set up and reserved for experienced centers. The objective of this protocol is to use a triple therapy based on 5FU and oxaliplatin associated to irinotecan which is administered by hepatic intra-arterial route, loaded onto microbeads (DEBIRI). Furthermore, the procedure for chemo-embolization DEBIRI is limited to 2 sessions, and therefore could be more easily generalized.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Hopital Saint André
Bordeaux, France
CHU - Hôpital François Mitterand
Dijon, France
Hôpital Prive Jean Mermoz
Lyon, France
Centre Léon Berard
Lyon, France
Institut Paoli Calmette
Marseille, France
CHU de la TIMONE
Marseille, France
Hôpital Europeen G Pompidou
Paris, France
CHU Charles Nicolle
Rouen, France
Hôpital Rangueil
Toulouse, France
Progression-free Survival Rate at 9 Months
The primary endpoint was to evaluate the rate of patients alive without progression at 9 months after the start of treatment. Events to be considered for the endpoint were: * Progression : defined as radiological progression according to RECIST V1.1 criteria, as assessed by the investigator. * Death Patients who progressed or died (from any cause) within 9 months of starting treatment were considered as failure for the primary endpoint. The first event which occured will be taken into accoun
Time frame: at 9 months after inclusion
Overall Survival
It was defined as the time interval between the date of inclusion and the date of death (whatever the cause). Patients lost to follow-up or alive at the time of analysis were censored at the date of last news.
Time frame: up to 4 years after patient's inclusion
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