NCT01678664

Everolimus After (Chemo)Embolization for Liver Metastases From Digestive Endocrine Tumors

Everolimus as Treatment After Embolization or Chemoembolization for Liver Metastases From Digestive Endocrine Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Federation Francophone de Cancerologie Digestive · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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%

Conditions

• Neuroendocrine Tumors
• Hepatic Metastases
• Metastases

Interventions

Type	Name	Description
DRUG	Everolimus	10 mg per day of everolimus during 24 months or until progression disease
DEVICE	embolization	2 sessions embolization with spheric particles
DRUG	Doxorubicin	2 sessions chemoembolization with 10 mg of lipiodol with 100 mg of doxorubicine

Timeline

• Start date: 2012-12-01
• Primary completion: 2018-09-01
• Completion: 2019-04-01
• First posted: 2012-09-05
• Last updated: 2024-09-25
• Results posted: 2024-09-25

Locations

18 sites across 1 country: France