Determine wether 24 months treatment with everolimus prolongs progression free survival rate (based on a central assessment) after embolisation ou chemoembolisation for liver metastases. * H0 a 24 months progression free survival rate less than 35% is unacceptable * H1 a 24 months progression free survival rate greater than 35% would show that everolimus treatment is beneficial, the expected 24 months progression free survival rate being 50%
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
74
10 mg per day of everolimus during 24 months or until progression disease
2 sessions embolization with spheric particles
2 sessions chemoembolization with 10 mg of lipiodol with 100 mg of doxorubicine
CHU - Hôtel Dieu
Angers, France
Hôpital Avicenne
Bobigny, France
Hôpital Saint André
Bordeaux, France
Hôpital Côte de Nacre
Caen, France
CHU - Estaing
Clermont-Ferrand, France
Hôpital Beaujon
Clichy, France
Centre GF Leclerc
Dijon, France
CHU - Hôpital François Mitterand
Dijon, France
Hôpital Edouard Herriot
Lyon, France
CHU La Timone
Marseille, France
...and 8 more locations
Rate of Hepatic Progression Free Survival at 24 Months
Hepatic progression free survival rate as defined in RECIST 1.1 (with death considered as progression) during the 24 months of treatment with everolimus. Progression-free survival rate (PFS) (based on the investigator) according to RECIST v1.1 according to RECIST v1.1 will be defined as the time from the date of inclusion to the date of hepatic progression or death (due to any cause). For patients who are alive with no hepatic progression, it will be defines as the time from the date of inclusion and the date of the last tumor assessment.
Time frame: Up to 24 months
Progression-free Survival (Hepatic or Not)
Progression-free survival rate was defined as the time from the date of inclusion to the date of disease progression (hepatic or not) evaluated by RECIST V1.1 criteria or death (due to any cause) or the date of the last news for alive patients
Time frame: From randomization until the date of first progression (clinical or radiological) or death from any cause whichever came first, assessed up to 3 years
Overall Survival
Overall survival was defined as the time from the date of inclusion to the date of death, regardless of the cause of death, or the date of last contact for patients who are alive.
Time frame: From randomization until death or last news for alive patients
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