RecruitingNCT02838602ETOILEUpdated Sep 2, 2021

Randomized Carbon Ions vs Standard Radiotherapy for Radioresistant Tumors

An interventional study of Carbon ions therapy and Advanced external radiotherapy by Xrays or protons in Malignant Tumors as Chordoma, Adenoid Cystic Carcinoma and Sarcoma, sponsored by Hospices Civils de Lyon. Recruiting at 21 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-02.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Treatment

From the registry’s dates

Started Dec 2017; still recruiting 8 years 9 months later.

Phase: Not applicable
Study type: Interventional
Enrollment: 250
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

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.

Conditions studied

Malignant Tumors as Chordoma, Adenoid Cystic Carcinoma and Sarcoma

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Keywords

carbon ions therapy
radiotherapy
radioresistant tumors
cancer
randomized trial

In context

Carcinoma, Adenoid Cystic

102 studies on the registry are indexed under Carcinoma, Adenoid Cystic; 23 are open to participants now.

This study's planned enrollment of 250 is above the median of 35 across 93 interventional studies indexed under Carcinoma, Adenoid Cystic.

Browse Carcinoma, Adenoid Cystic studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

age ≥ 18 years
No severe comorbidity, life expectancy above 10 years
Unresectable or inoperable or R2 resection of the tumor
Eligible radioresistant tumor according to the limitative list as following:
- adenoid cystic carcinoma of head and neck (larynx and trachea excluded)
- soft tissue sarcoma
- pleomorphic rhabdomyosarcoma only (alveolar and embryonal forms excluded)
- retroperitoneal sarcoma under condition of technical feasibility (movement)
- osteosarcoma of any grade and localisation (Ewing excluded)
- chondrosarcoma (except of skull base) OMS grade >= 2
- chordoma axial skeleton or pelvis (except of skull base)
- angiosarcoma
Absence of epidermal invasion (a hypodermic invasion is accepted with fixity of cutaneous plan but not true epidermal permeation)
Larger volume to be irradiated (PTV) less than 25 cm
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.

Exclusion criteria

Exclusion Criteria:

Complete macroscopic or microscopic surgical resection (R0 or R1)
previous irradiation in the volume to be treated
metastatic disease
disease not candidate to a curative approach (example accelerated progressive diseaseresistant to nay medical treatment especially for sarcoma)
any contra-indication to undergo a radiation therapy by Xray or particle therapy
planned surgery or chemotherapy to take place after completion of radiotherapy (example : absence of enough space between an organ risk and the target volume (at least 5 mm) except the possibility of a spacer insertion)
planned surgery or chemotherapy after radiotherapy
Presence in the target volume of metallic material which cannot be removed (carbon fibres matreial authorized)
history of concomittant (except in situ cervix carcinoma; or any cured basocellular cutaneous cancer tor any cured cancer with no sign of relapse during 5 years))
impossible follow-up over 5 years

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 250 participants (estimated)

Study arms

Experimental
Carbon ions therapy
Radical and exclusive carbon ions radiotherapy
Radiation: Carbon ions therapy
Active comparator
Conventional radiotherapy
Radical radiotherapy by Xrays and / or protons
Radiation: Advanced external radiotherapy by Xrays or protons

Interventions

RadiationCarbon ions therapy
External radiotherapy by accelerated carbon nucleus in a specialized hadrontherapy center
RadiationAdvanced external radiotherapy by Xrays or protons
Radiotherapy by any appropriate advance procedure of photontherapy (IMRT, Volumetric Modulated Arc Therapy (VMAT), Tomo, etc.) or when possible by protontherapy or even a combination of both types of radiotherapy

What researchers measure

Primary outcomes

Progression free survival (PFS)
Starting point for PFS measurement is the randomization date
Time frame: up to 5 years or loss of follow-up

Secondary outcomes

Grades of the CTCAE-V4.02 classification
Tolerance
Time frame: up to 5 years or loss of follow-up
EQ-5D questionnaire
Quality of life
Time frame: up to 5 years or loss of follow-up
Local progression free survival
takes account of the local progression of the tumor in the planning target volume (PTV)
Time frame: up to 5 years or loss of follow-up
Metastases free survival
takes account of any site of relapse outside of the PTV
Time frame: up to 5 years or loss of follow-up
Overall survival
delay of death of any cause accounted starting from randomization
Time frame: up to 5 years or loss of follow-up

Study locations

13 of 21 sites recruiting

CHU Amiens - Hôpital Sud
Amiens, 80054, France
- Claude KRZISCH, MD · Contact
- Claude KRZISCH, MD · Principal investigator
Recruiting
Radiothérapie, CLCC François Baclesse
Caen, 14076, France
- Juliette THARIAT, MD · Contact
- Juliette THARIAT, MD · Principal investigator
- Dinu STEFAN, MD · Sub investigator
- Delphine LEROUGE, MD · Sub investigator
- Bernard GERY, MD · Sub investigator
- Laura MOISE, MD · Sub investigator
- Sabine NOAL, MD · Sub investigator
- Jacques BALOSSO, MD · Sub investigator
Recruiting
Radiothérapie, CRLCC Jean Perrin
Clermont-Ferrand, 63011, France
- Fanny MARTIN · Contact
- Fanny MARTIN, MD · Principal investigator
- Michel LAPEYRE, MD · Sub investigator
- Jessica MIROIR, MD · Sub investigator
Not yet recruiting
Radiothérapie, CRLCC GF Leclerc
Dijon, 21034, France
- Gilles TRUC, MD · Contact · 03.80.73.75.18
- Gilles TRUC, MD · Principal investigator
- Noémie VULQUIN, MD · Sub investigator
- David THIBOUW, MD · Sub investigator
- Caroline AMOYAL, MD · Sub investigator
Recruiting
Radiothérapie, Hôpital A. Michallon, CHU de Grenoble
Grenoble, 38043, France
- Camille, Olivier VERRY, MD · Contact · 04.76.76.54.35
- Camille, Olivier VERRY, MD · Principal investigator
- Julie VILLA, MD · Sub investigator
- Jacques BALOSSO, MD · Sub investigator
- Carole IRIART, MD · Sub investigator
- Violaine BRUN-BARONNAT, MD · Sub investigator
Recruiting
Radiothérapie, CRLCC Oscar Lambret
Lille, 59020, France
- Xavier MIRABEL, MD · Contact · 03.20.29.55.98
- Xavier MIRABEL, MD · Principal investigator
- Raphaëlle MOUTTET-AUDOUARD, MD · Sub investigator
- Abel CORDOBA, MD · Sub investigator
- Xavier LIEM, MD · Sub investigator
- David PASQUIER, MD · Sub investigator
Recruiting
Radiothérapie, CRLCC Léon Bérard
Lyon, 69373, France
- Pascal POMMIER, MD · Contact · pascal.pommier@lyon.unicancer.fr · (0)4 78 78 51 66
- Pascal POMMIER, MD · Principal investigator
- Marie-Pierre SUNYACH, MD · Sub investigator
- Vincent GREGOIRE, MD · Sub investigator
Recruiting
Radiothérapie, CRLCC Institut Paoli Calmettes
Marseille, 13009, France
- Laurence MOUREAU-ZABOTTO, MD · Contact · 04.91.22.36.37
- Laurence MOUREAU-ZABOTTO, MD · Principal investigator
Not yet recruiting
Radiothérapie, Institut Régional du Cancer Montpellier, ICM Val d'Aurelle
Montpellier, 34298, France
- Pierre BOISSELIER, MD · Contact
- Pierre BOISSELIER, MD · Principal investigator
Recruiting
Pôle de radiothérapie, Centre Antoine-Lacassagne
Nice, 06189, France
- Alexander FALK, MD · Contact
- Alexander FALK, MD · Principal investigator
- Jérôme DOYEN, MD · Sub investigator
- Pierre-Yves BONDIAU, MD · Sub investigator
- Karen BENEZERY, MD · Sub investigator
Recruiting
Radiothérapie, CHU Pitié-Salpétrière
Paris, 75013, France
- Loïc FEUVRET · Contact · 01.42.17.81.71
- Loïc FEUVRET, MD · Principal investigator
Not yet recruiting
Institut Curie, site Hôpital de Paris et site d'Orsay (Centre de protonthérapie)
Paris, 75231, France
- Rémi DENDALE, MD · Contact
- Rémi DENDALE, MD · Principal investigator
- Claire ALAPETITE, MD · Sub investigator
Not yet recruiting
Radiothérapie, Hôpital de Haut Lévêque, CHU Bordeaux
Pessac, 33604, France
- Charles DUPIN, MD · Contact
- Charles DUPIN, MD · Principal investigator
- Huchet AYMERI, MD · Sub investigator
Not yet recruiting
Radiothérapie, CRLCC Institut Jean Godinot
Reims, 51726, France
- Stéphanie SERVAGI-VERNAT, MD · Contact
- Stéphanie SERVAGI-VERNAT, MD · Principal investigator
Recruiting
Centre Eugene Marquis
Rennes, 35000, France
- Joël CASTELLI, MD · Contact
- Joël CASTELLI, MD · Principal investigator
Not yet recruiting
Radiothérapie, CRLCC René Gauducheau
Saint-Herblain, 44805, France
- Augustin MERVOYER, MD · Contact · 02.40.67.99.30
- Augustin MERVOYER, MD · Principal investigator
- Nadia WIAZZANE, MD · Sub investigator
Not yet recruiting
Radiothérapie, Institut de Cancérologie de la Loire Lucien Neuwirtz
St Priest en Jarez, 42270, France
- Nicolas MAGNE, MD · Contact
- Nicolas MAGNE, MD · Principal investigator
- Amel REHAILIA-BLANCHARD, MD · Sub investigator
- Grégoire PIGNE, MD · Sub investigator
Recruiting
Radiothérapie, CRLCC Paul Strauss
Strasbourg, 67065, France
- Georges NOEL, MD · Contact · 03.88.25.24.71
- Georges NOEL, MD · Principal investigator
Recruiting
Institut universitaire du cancer de Toulouse - Oncopole, Institut Claudius Regaud
Toulouse, 31059, France
- Anne DUCASSOU, MD · Contact
- Anne DUCASSOU, MD · Principal investigator
- Anne LAPRIE, MD · Principal investigator
- Martine DELANNES, MD · Sub investigator
Recruiting
Radiothérapie, Institut de Cancérologie de Lorraine Alexis Vautrin
Vandœuvre-lès-Nancy, 54500, France
- Guillaume VOGIN, MD · Contact · 03.83.59.84.27
- Guillaume VOGIN, MD · Principal investigator
- Sophie RENARD, MD · Sub investigator
Recruiting
Radiothérapie, Institut Gustave Roussy
Villejuif, 94805, France
- Cécile LE PECHOUX, MD · Contact · 01.42.11.42.11
- Cécile LE PECHOUX, MD · Principal investigator
- Stéphanie BOLLE, MD · Sub investigator
Not yet recruiting

References and documents

Publications

Balosso J, Febvey-Combes O, Iung A, Lozano H, Alloh AS, Cornu C, Herve M, Akkal Z, Lievre M, Plattner V, Valvo F, Bono C, Fiore MR, Vitolo V, Vischioni B, Patin S, Allemand H, Gueyffier F, Margier J, Guerre P, Chabaud S, Orecchia R, Pommier P. 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. BMC Cancer. 2022 May 23;22(1):575. doi: 10.1186/s12885-022-09564-7. PubMed 35606739 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02838602
Lead sponsor: Hospices Civils de Lyon
Responsible party: Sponsor
First posted: Jul 20, 2016
Start date: Dec 23, 2017
Primary completion: Dec 23, 2026 (estimated)
Completion: Dec 23, 2026 (estimated)
Last update: Sep 2, 2021

Study contacts

Pascal POMMIER, MD

Contact

pascal.pommier@lyon.unicancer.fr

(0)4 78 78 51 66 ext. +33

Pascal POMMIER, MD

principal investigator · Centre Leon Berard

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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