TY - JOUR
T1 - A randomized controlled phase III study comparing hadrontherapy with carbon ions versus conventional radiotherapy – including photon and proton therapy – for the treatment of radioresistant tumors
T2 - the ETOILE trial
AU - Balosso, Jacques
AU - Febvey-Combes, Olivia
AU - Iung, Annie
AU - Lozano, Hélène
AU - Alloh, Abdoulkader Soumai
AU - Cornu, Catherine
AU - Hervé, Magali
AU - Akkal, Zohra
AU - Lièvre, Michel
AU - Plattner, Valérie
AU - Valvo, Francesca
AU - Bono, Cristina
AU - Fiore, Maria Rosaria
AU - Vitolo, Viviana
AU - Vischioni, Barbara
AU - Patin, Stéphanie
AU - Allemand, Hubert
AU - Gueyffier, François
AU - Margier, Jennifer
AU - Guerre, Pascale
AU - Chabaud, Sylvie
AU - Orecchia, Roberto
AU - Pommier, Pascal
N1 - Funding Information:
The trial is funded by the Programme Hospitalier de Recherche Clinique en cancérologie (PHRC-K, 2011) from the French Ministry of Health, and the study protocol has undergone external peer review during the funding process. The French National Health Insurance Fund (Caisse nationale de l’Assurance Maladie, CNAM) pays for the experimental treatment. The French League against cancer (Ligue Nationale contre le Cancer) agrees to support patients when needed. The funders will not be involved in data collection, analysis, and interpretation of data.
Funding Information:
We want to thank the ULICE project for the so-called HIRO-ULICE platform , which is a specific service provided by the NEXUS/CHILI GmbH, Dossenheim, Germany, near Heidelberg, initially developed for hadrontherapy clinical research purposes and having been co-funded in the frame of the European Commission FP7 INFRASTRUCTURE – 2008 – 1 – 228436 agreement: ULICE project.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/12
Y1 - 2022/12
N2 - Background: Some cancers such as sarcomas (bone and soft tissue sarcomas) and adenoid cystic carcinomas are considered as radioresistant to low linear energy transfer radiation (including photons and protons) and may therefore beneficiate from a carbon ion therapy. Despite encouraging results obtained in phase I/II trials compared to historical data with photons, the spread of carbon ions has been limited mainly because of the absence of randomized medical data. The French health authorities stressed the importance of having randomized data for carbon ion therapy. Methods: The ETOILE study is a multicenter prospective randomized phase III trial comparing carbon ion therapy to either advanced photon or proton radiotherapy for inoperable or macroscopically incompletely resected (R2) radioresistant cancers including sarcomas and adenoid cystic carcinomas. In the experimental arm, carbon ion therapy will be performed at the National Center for Oncological Hadrontherapy (CNAO) in Pavia, Italy. In the control arm, photon or proton radiotherapy will be carried out in referent centers in France. The primary endpoint is progression-free survival (PFS). Secondary endpoints are overall survival and local control, toxicity profile, and quality of life. In addition, a prospective health-economic study and a radiobiological analysis will be conducted. To demonstrate an absolute improvement in the 5-year PFS rate of 20% in favor of carbon ion therapy, 250 patients have to be included in the study. Discussion: So far, no clinical study of phase III has demonstrated the superiority of carbon ion therapy compared to conventional radiotherapy, including proton therapy, for the treatment of radioresistant tumors. Trial registration: ClinicalTrials.gov identifier: NCT02838602. Date of registration: July 20, 2016. The posted information will be updated as needed to reflect protocol amendments and study progress.
AB - Background: Some cancers such as sarcomas (bone and soft tissue sarcomas) and adenoid cystic carcinomas are considered as radioresistant to low linear energy transfer radiation (including photons and protons) and may therefore beneficiate from a carbon ion therapy. Despite encouraging results obtained in phase I/II trials compared to historical data with photons, the spread of carbon ions has been limited mainly because of the absence of randomized medical data. The French health authorities stressed the importance of having randomized data for carbon ion therapy. Methods: The ETOILE study is a multicenter prospective randomized phase III trial comparing carbon ion therapy to either advanced photon or proton radiotherapy for inoperable or macroscopically incompletely resected (R2) radioresistant cancers including sarcomas and adenoid cystic carcinomas. In the experimental arm, carbon ion therapy will be performed at the National Center for Oncological Hadrontherapy (CNAO) in Pavia, Italy. In the control arm, photon or proton radiotherapy will be carried out in referent centers in France. The primary endpoint is progression-free survival (PFS). Secondary endpoints are overall survival and local control, toxicity profile, and quality of life. In addition, a prospective health-economic study and a radiobiological analysis will be conducted. To demonstrate an absolute improvement in the 5-year PFS rate of 20% in favor of carbon ion therapy, 250 patients have to be included in the study. Discussion: So far, no clinical study of phase III has demonstrated the superiority of carbon ion therapy compared to conventional radiotherapy, including proton therapy, for the treatment of radioresistant tumors. Trial registration: ClinicalTrials.gov identifier: NCT02838602. Date of registration: July 20, 2016. The posted information will be updated as needed to reflect protocol amendments and study progress.
KW - Carbon ion therapy
KW - Photon therapy
KW - Proton therapy
KW - Radioresistant tumors
KW - Radiotherapy
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UR - http://www.scopus.com/inward/citedby.url?scp=85130450013&partnerID=8YFLogxK
U2 - 10.1186/s12885-022-09564-7
DO - 10.1186/s12885-022-09564-7
M3 - Article
C2 - 35606739
AN - SCOPUS:85130450013
SN - 1471-2407
VL - 22
JO - BMC Cancer
JF - BMC Cancer
IS - 1
M1 - 575
ER -