Abstract | BACKGROUND: 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: 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.
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Authors | Jacques Balosso, Olivia Febvey-Combes, Annie Iung, Hélène Lozano, Abdoulkader Soumai Alloh, Catherine Cornu, Magali Hervé, Zohra Akkal, Michel Lièvre, Valérie Plattner, Francesca Valvo, Cristina Bono, Maria Rosaria Fiore, Viviana Vitolo, Barbara Vischioni, Stéphanie Patin, Hubert Allemand, François Gueyffier, Jennifer Margier, Pascale Guerre, Sylvie Chabaud, Roberto Orecchia, Pascal Pommier |
Journal | BMC cancer
(BMC Cancer)
Vol. 22
Issue 1
Pg. 575
(May 23 2022)
ISSN: 1471-2407 [Electronic] England |
PMID | 35606739
(Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Copyright | © 2022. The Author(s). |
Chemical References |
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Topics |
- Carbon
(adverse effects)
- Carcinoma, Adenoid Cystic
- Heavy Ion Radiotherapy
(adverse effects)
- Humans
- Ions
(therapeutic use)
- Photons
(adverse effects)
- Prospective Studies
- Proton Therapy
(adverse effects)
- Protons
- Quality of Life
- Sarcoma
(drug therapy)
- Soft Tissue Neoplasms
(drug therapy)
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