Everolimus After (Chemo)Embolization for Liver Metastases From Digestive Endocrine Tumors (EVACEL)
|ClinicalTrials.gov Identifier: NCT01678664|
Recruitment Status : Completed
First Posted : September 5, 2012
Last Update Posted : March 30, 2020
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%
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors Hepatic Metastases Metastases||Drug: Everolimus Device: embolization Drug: Doxorubicin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Everolimus as Treatment After Embolization or Chemoembolization for Liver Metastases From Digestive Endocrine Tumors|
|Actual Study Start Date :||October 2012|
|Actual Primary Completion Date :||September 2018|
|Actual Study Completion Date :||April 2019|
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 disease
2 sessions embolization with spheric particles
Other Name: spheric particules of 100 to 500 µm
2 sessions chemoembolization with 10 mg of lipiodol with 100 mg of doxorubicine
Other Name: Chemoembolization
- Rate of hepatic progression free survival at 24 months [ Time Frame: 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 (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 ]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 ]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 ]the toxicities recorded at each monthly visit, described using -CTCAE version 4.0; grade 3 and 4 toxicities will be reviewed;
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678664
|Principal Investigator:||Thomas WALTER, PhD||Hôpital Edouard Herriot - Lyon|