Everolimus After (Chemo)Embolization for Liver Metastases From Digestive Endocrine Tumors (EVACEL)
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 Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Everolimus as Treatment After Embolization or Chemoembolization for Liver Metastases From Digestive Endocrine Tumors|
- Rate of hepatic progression free survival at 24 months [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Hepatic progression free survival rate as defined in RECIST 1.1 (with death considered as progression) during the 24 months of treatment with everolimus (appendix 3).
Progression-free survival rate (PFS) (based on the central assessment) 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.
- Progression free survival rate (hepatic or not) at 24 months [ Time Frame: 24 months ] [ Designated as safety issue: No ]Progression-free survival rate will be 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 morphological evaluation for patients who are alive with no disease progression.
- Overall survival rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]Overall survival rate shall be 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.
- Toxicities treatment [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]the toxicities recorded at each monthly visit, described using -CTCAE version 4.0; grade 3 and 4 toxicities will be reviewed;
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||April 2017|
|Estimated Primary Completion Date:||April 2017 (Final data collection date for primary outcome measure)|
Experimental: embolization or chemoembolization plus everolimus
After 2 sessions of embolization with microsphere of 100 to 500 µm or chemoembolization with 100 mg of doxorubicine and 10 ml of lipiodol, administered every day, 10 mg of everolimus during 24 months or until progression (hepatic and other site).
10 mg per day of everolimus during 24 months or until progression diseaseDevice: embolization
2 sessions embolization with spheric particles
Other Name: spheric particules of 100 to 500 µmDrug: Doxorubicin
2 sessions chemoembolization with 10 mg of lipiodol with 100 mg of doxorubicine
Other Name: Chemoembolization
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678664
|Hôpital Saint André|
|Hôpital Côte de Nacre|
|Clermont Ferrand, France|
|Centre GF Leclerc|
|Hôpital Edouard Herriot|
|CHU La Timone|
|Hôpital Saint Joseph|
|Hôpital Européen Georges Pompidou|
|Hôpital Robert Debré|
|Institut Gustave Roussy|
|Principal Investigator:||Thomas WALTER, PhD||Hôpital Edouard Herriot - Lyon|