Evidence map›Paper›PMID 35606739›Full record

Trial reportBMC cancer2022

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: the ETOILE trial.

Jacques Balosso, Olivia Febvey-Combes, Annie Iung, Hélène Lozano, Abdoulkader Soumai Alloh, Catherine Cornu, Magali Hervé, Zohra Akkal, Michel Lièvre, Valérie Plattner and 13 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02838602 (Transnational Randomized Study Comparing Carbon Ions Therapy Versus Conventional Radiotherapy - Including Protontherapy - for the Treatment of Radioresistant Tumors), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.9field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02838602 narecruitingnot on this map

Transnational Randomized Study Comparing Carbon Ions Therapy Versus Conventional Radiotherapy - Including Protontherapy - for the Treatment of Radioresistant Tumors

TypeinterventionalSponsorHospices Civils de LyonRan2017 to 2026Enrolled250ConditionsMalignant Tumors as Chordoma, Adenoid Cystic Carcinoma and SarcomaArmsCarbon ions therapy, Advanced external radiotherapy by Xrays or protons
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 22 citations in OpenAlex.

  1. Article
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  12. Advances in Radiation Therapy for Primary Bone Malignancies.Technology in cancer research & treatment
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors at 6 institutions in 3 countries.

Jacques BalossoCentre François Baclesse, Service de radiothérapie, BP 45026, F-14076, Caen, Cedex 5, France. j.balosso@baclesse.unicancer.fr.ORCID http://orcid.org/0000-0003-0714-9003
Olivia Febvey-CombesHospices Civils de Lyon, Pôle de Santé Publique, Lyon, France.
Annie IungHospices Civils de Lyon, Direction de la Recherche en Santé, Lyon, France.
Hélène LozanoHospices Civils de Lyon, Pôle de Santé Publique, Lyon, France.
Abdoulkader Soumai AllohHospices Civils de Lyon, Direction de la Recherche en Santé, Lyon, France.
Catherine CornuUMR 5558, Université Claude Bernard Lyon 1, Lyon, France.
Magali HervéHospices Civils de Lyon, Pôle de Santé Publique, Lyon, France.
Zohra AkkalHospices Civils de Lyon, Pôle de Santé Publique, Lyon, France.
Michel LièvreUMR 5558, Université Claude Bernard Lyon 1, Lyon, France.
Valérie PlattnerHospices Civils de Lyon, Direction de la Recherche en Santé, Lyon, France.
Francesca ValvoCentro Nazionale di Adroterapia Oncologica, Pavia, Italy.
Cristina BonoCentro Nazionale di Adroterapia Oncologica, Pavia, Italy.
Maria Rosaria FioreCentro Nazionale di Adroterapia Oncologica, Pavia, Italy.
Viviana VitoloCentro Nazionale di Adroterapia Oncologica, Pavia, Italy.
Barbara VischioniCentro Nazionale di Adroterapia Oncologica, Pavia, Italy.
Stéphanie PatinGroupement Coopération Sanitaire Centre Etoile, Lyon, France.
Hubert AllemandCaisse Nationale d'Assurance Maladie des Travailleurs Salariés, Paris, France.
François GueyffierHospices Civils de Lyon, Pôle de Santé Publique, Lyon, France.
Jennifer MargierHospices Civils de Lyon, Pôle de Santé Publique, Lyon, France.
Pascale GuerreHospices Civils de Lyon, Pôle de Santé Publique, Lyon, France.
Sylvie ChabaudCentre Léon Bérard, Direction de la Recherche Clinique et de l'Innovation, Lyon, France.
Roberto OrecchiaCentro Nazionale di Adroterapia Oncologica, Pavia, Italy.
Pascal PommierCentre Léon Bérard, Service de Radiothérapie, Lyon, France.
Hospices Civils de Lyon · FRNational Center for Oncological Hadrontherapy · ITUniversité Claude Bernard Lyon 1 · FRCentre Léon Bérard · FRCentre François Baclesse · LUl'Assurance Maladie · FR

Funding

French ministry of health PHRC-K 11-115
6 · The paper itself

Abstract

backgroundSome 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.

methodsThe 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 registrationClinicalTrials.gov identifier: NCT02838602 . Date of registration: July 20, 2016. The posted information will be updated as needed to reflect protocol amendments and study progress.

Indexed as

Carcinoma, Adenoid CysticHeavy Ion RadiotherapyProton TherapySarcomaSoft Tissue NeoplasmsCarbonHumansIonsPhotonsProspective StudiesProtonsQuality of LifeCarbonIonsProtonsCarbon ion therapyPhoton therapyProton therapyRadioresistant tumorsRadiotherapy

Identifiers

PMID35606739
PMCPMC9128242
OpenAlexW4281382329

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.