CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 74 enrolled
Drug / intervention
Everolimus +2 moredrug
Likely dose
Everolimus 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01678664
NCT01678664Phase 2Completed
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Everolimus as Treatment After Embolization or Chemoembolization for Liver Metastases From Digestive Endocrine Tumors

Federation Francophone de Cancerologie Digestive·interventional·Posted Sep 5, 2012·Updated Sep 25, 2024

In Brief

A Phase 2 clinical trial evaluating Everolimus, embolization, and 1 other intervention for Neuroendocrine Tumors and 2 related conditions. Completed, enrolled 74 participants across 18 sites.

Detailed 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%

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuroendocrine Tumors, Hepatic Metastases, Metastases
CountriesFrance
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 5, 2012
Enrollment StartDec 1, 2012
Primary CompletionSep 1, 2018
Study CompletionApr 1, 2019
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 13.8 years ago

Interventions

Everolimusdrug

10 mg per day of everolimus during 24 months or until progression disease

embolizationdevice

2 sessions embolization with spheric particles

Doxorubicindrug

2 sessions chemoembolization with 10 mg of lipiodol with 100 mg of doxorubicine