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Neuroendocrine TumorsPhase 2EVACELNCT01678664

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

A Phase 2 study testing Everolimus, embolization and Doxorubicin in people with Neuroendocrine Tumors and Hepatic Metastases, run by Federation Francophone de Cancerologie Digestive at 18 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Everolimus, embolization and Doxorubicin
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
18 sitesFrance
Study dates
Dec 2012to Apr 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Well differentiated (grade 1 and 2 according to WHO classification 2010 appendix 2), histologically-proven endocrine tumor of the gastrointestinal tract (TENpath review mandatory),
  • Measurable liver metastasis (or metastases) as defined in RECIST v1.1 that are unresectable and inaccessible to radiofrequency ablation-type local treatment
  • Hepatic arterial embolization or chemoembolization indicated for tumor size reduction, confirmed in an multidisciplinary team (MDT) meeting, due to the progressive nature of the liver metastases (morphological progression during the past 12 months as defined in RECIST v1.1)
  • Age ≥ 18 years
  • WHO performance status ≤ 2
  • No contraindications to embolization or chemoembolization or everolimus
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  • Satisfactory laboratory assessments:Neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, Hb > 10 g/dL, serum bilirubin ≤ 1.5 x the upper limit of normal (ULN), INR < 1.3 (or < 3 for patients on anticoagulant therapy) ALT and AST ≤ 5 x ULN, creatinine ≤ 1.5 x ULN, fasting serum cholesterol ≤ 300 mg/dL or 7.75 mmol/L and triglycerides ≤ 2.5 x ULN (if either or both of these limits are exceeded, the patient may only be included into the study after institution of appropriate lipid-lowering therapy)
  • Complete resolution of toxic effects of any prior treatments, or persistence at grade 1 at most (CTCAE version 4.0)
  • Minimum time since previous treatment: 28 days
  • Patient has been informed and has signed an informed consent form, after verification of the eligibility criteria
  • Patient covered by a French national health insurance scheme

Who cannot join

  • Duodenopancreatic neuroendocrine tumor
  • Poorly differentiated and/or grade 3 endocrine tumor,
  • Embolization or chemoembolization indicated for symptomatic control only
  • Prior hepatic TACE or embolization
  • Prior treatment with an mTOR inhibitor (somatostatin analogs to control secretion are permitted)
  • Symptomatic bone metastasis (or metastases)
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  • Any uncontrolled progressive disease: hepatic failure, renal failure, respiratory failure, NYHA class III-IV congestive heart failure, unstable angina, myocardial infarction, significant arrhythmia
  • Interstitial lung disease
  • Uncontrolled diabetes, defined by HbA1c > 8%
  • Chronic corticosteroid or immunosuppressant therapy
  • Hypersensitivity to everolimus, other rapamycin derivatives, or one of the excipients
  • Major surgery, open biopsy, or significant traumatic lesion during the 28 days prior to starting the investigational treatment Incompletely healed wound or foreseeable need for major surgery during the study
  • Contraindication to vascular occlusion procedures: Portal thrombosis, biliodigestive anastomosis
  • Malignancy during the past 5 years, with the exception of curatively treated basal cell skin carcinoma or in situ cervical cancer
  • Foreseeable non-compliance
  • Medical, geographic, sociological, psychological, or legal situation that would preclude the patient from completing the study or signing an informed consent form
  • Pregnant or breast-feeding women
  • Men or women of child-bearing potential not using effective contraception
  • Concurrent participation in another investigational study that could affect the primary endpoint of this study

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

France18 sites

  • CHU - Hôtel Dieu

    Angers

  • Hôpital Avicenne

    Bobigny

  • Hôpital Saint André

    Bordeaux

  • Hôpital Côte de Nacre

    Caen

  • CHU - Estaing

    Clermont-Ferrand

  • Hôpital Beaujon

    Clichy

  • Centre GF Leclerc

    Dijon

  • CHU - Hôpital François Mitterand

    Dijon

  • Hôpital Edouard Herriot

    Lyon

  • CHU La Timone

    Marseille

  • CHR

    Orléans

  • CHU Cochin

    Paris

  • Hôpital Européen Georges Pompidou

    Paris

  • Hôpital Robert Debré

    Reims

  • CHU

    Rouen

  • Hôpital Rangueil

    Toulouse

  • Hôpital Trousseau

    Tours

  • Institut Gustave Roussy

    Villejuif

Other trials in France

About this study

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

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%
Being tested
Everolimus, embolization, Doxorubicin
Keywords
cancer, neuroendocrine tumors, gastrointestinal tract, metastases, liver, hepatic
Medical subject headings
Neuroendocrine Tumors, Neoplasm Metastasis, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EverolimusDrug

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

  • embolizationDevice

    Also called spheric particules of 100 to 500 µm

    2 sessions embolization with spheric particles

  • DoxorubicinDrug

    Also called Chemoembolization

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

Study groups in NCT01678664
Study groupRoleWhat they receive
embolization or chemoembolization plus everolimusExperimentalAfter 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).
Receives: Drug: Everolimus; Device: embolization; Drug: Doxorubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Hepatic Progression Free Survival at 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.

    Progression-free survival rate (PFS) (based on the investigator) 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.

    Measured: Up to 24 months

Secondary outcomes (2)

  1. Progression-free Survival (Hepatic or Not)

    Progression-free survival rate was 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 news for alive patients

    Measured: From randomization until the date of first progression (clinical or radiological) or death from any cause whichever came first, assessed up to 3 years

  2. Overall Survival

    Overall survival was 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.

    Measured: From randomization until death or last news for alive patients

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionSep 2018
  4. Study completionApr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01678664
Sponsor's protocol ID
FFCD 1104
Acronym
EVACEL
Status last verified
Sep 2024
First submitted
22 Aug 2012
Last updated
25 Sep 2024
Data monitoring committee
Yes

Publications

  • Walter T, Lepage C, Coriat R, Barbier E, Cadiot G, Caroli-Bosc FX, Aparicio T, Bouhier-Leporrier K, Hentic-Dhome O, Gay F, Dupont-Gossart AC, Duluc M, Lepere C, Lecomte T, Smith D, Petorin C, Di-Fiore F, Ghiringhelli F, Legoux JL, Guimbaud R, Baudin E, Lombard-Bohas C, de Baere T; FFCD 1104 investigators/investigators. Everolimus after hepatic arterial embolisation therapy of metastases from gastrointestinal neuroendocrine tumours: The FFCD 1104-EVACEL-GTE phase II study. Eur J Cancer. 2019 Dec;123:92-100. doi: 10.1016/j.ejca.2019.09.021. Epub 2019 Oct 31.

    PubMed 31678771

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Everolimus, embolization and Doxorubicin in people with Neuroendocrine Tumors and Hepatic Metastases, run by Federation Francophone de Cancerologie Digestive at 18 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Hepatic Progression Free Survival at 24 Months (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01678664, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.

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