Etude : ETOILE /

ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.

Acronyme / Nom
Situation thérapeutique
Cadre réglementaire
Présentation de l'étude
Acronyme / Nom : ETOILE

Situation thérapeutique :

Traitement : Radiothérapie

Cadre réglementaire : RIPH1

Dernière MÀJ : 15/12/2021
CIM10 - Localisation(s)
Informations principales
Titre : Transnational Randomized Study Comparing Carbon Ions Therapy Versus Conventional Radiotherapy - Including Protontherapy - for the Treatment of Radioresistant Tumors

Spécialité : Toutes tumeurs solides
Localisation : C - Toutes localisations
Informations complémentaires
Schéma : This is a transnational prospective randomized trial comparing definitive carbon ion therapy versus photon or combined photon and protontherapy as standard treatment for unresectable or macroscopically uncompleted resected radioresistant tumors. Eligible tumors are axial chordoma (except of base of skull), adenoid cystic carcinoma of head and neck (except of trachea) and sarcomas of any site (except chondrosarcoma of the skull base), non previously irradiated and without pre-planned surgery or chemotherapy after the clinical trial procedure. Randomization is balanced 1 for 1. Patients of the experimental arm are treated in carbon ions centers in Europe and patients of the standard arm are treated in France in their closest participating radiotherapy center. An accrual of 250 patients is needed and an absolute difference of 20% of relapse free survival at five years is awaited. The main endpoint is the progression free survival at five years. The trial is supported by the French program of clinical research and the national health insurance. Two associated studies are carried out: a radiobiological one looking for radioresistance markers in the sarcomas biopsies, and the second one is about medico economics.

Phase : III

Stade : Localisé à Localement avancé

Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - age ≥ 18 years
- No severe comorbidity, life expectancy above 10 years
- Unresectable or inoperable or R2 resection of the tumor
- Radioresistant tumor according to the limitative list as following:
adenoid cystic carcinoma of head and neck (larynx and trachea excluded)
soft tissue sarcoma
retroperitoneal sarcoma
osteosarcoma (Ewing excluded)
chondrosarcoma (except of skull base)
axial skeleton chordoma (except of skull base)
- No skin involvement
- ECOG Performance Status ≤ 2 or Karnovsky index ≥ 60
- no pregnancy of possibility of pregnancy during the treatment
- having an health insurance
- signature of a written informed consent
- validation of the randomization criteria: namely, a carbon ions therapy indication assessed by the medical team of a hadrontherapy center and able to by treated within two month from registration.

Critères de non-inclusion : - previous irradiation in of the same tumor site
- active metastatic disease
- any contra-indication to undergo a radiation therapy by Xray or particle therapy
- planned surgery or chemotherapy to take place after completion of radiotherapy
- removable metallic material in the planning target volume
- any history of another cancer in remission since less than 5 years (except in situ cervix carcinoma of basocellular skin cancer treated in a curative manner)
- impossible follow-up.
Informations relatives au promoteur
Promoteur :
HOSPICES civils de Lyon
Type de sponsor : Institutionnel
69002 LYON 02

Coordonnateur :
Docteur Pascal POMMIER
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
Centre Oscar Lambret - 3 Rue Frédéric Combemale - 59000 LILLE

Investigateur :
Docteur Xavier MIRABEL

Unité Intégrée de Recherche Clinique

Statut de l'essai : CLOS

MAJ : 14/12/2021