MedTrace Logo

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

NCT01678664 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2024-09-25

Study results available
· View outcomes & findings →

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

Interventions

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

Sponsors & Collaborators

  • Federation Francophone de Cancerologie Digestive

    lead OTHER

Principal Investigators

  • Thomas WALTER, PhD · Hôpital Edouard Herriot - Lyon

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2018-09-30
Completion
2019-04-30

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01678664 on ClinicalTrials.gov