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Randomized Carbon Ions vs Standard Radiotherapy for Radioresistant Tumors (ETOILE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02838602
Recruitment Status : Recruiting
First Posted : July 20, 2016
Last Update Posted : March 7, 2018
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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.

Condition or disease Intervention/treatment Phase
Malignant Tumors as Chordoma, Adenoid Cystic Carcinoma and Sarcoma Radiation: Carbon ions therapy Radiation: Advanced external radiotherapy by Xrays or protons Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transnational Randomized Study Comparing Carbon Ions Therapy Versus Conventional Radiotherapy - Including Protontherapy - for the Treatment of Radioresistant Tumors
Actual Study Start Date : December 23, 2017
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : May 2024

Arm Intervention/treatment
Experimental: Carbon ions therapy
Radical and exclusive carbon ions radiotherapy
Radiation: Carbon ions therapy
External radiotherapy by accelerated carbon nucleus in a specialized hadrontherapy center

Active Comparator: Conventional radiotherapy
Radical radiotherapy by Xrays and / or protons
Radiation: Advanced 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

Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: up to 5 years or loss of follow-up ]
    Starting point for PFS measurement is the randomization date

Secondary Outcome Measures :
  1. Grades of the CTCAE-V4.02 classification [ Time Frame: up to 5 years or loss of follow-up ]

  2. EQ-5D questionnaire [ Time Frame: up to 5 years or loss of follow-up ]
    Quality of life

  3. Local progression free survival [ Time Frame: up to 5 years or loss of follow-up ]
    takes account of the local progression of the tumor in the planning target volume (PTV)

  4. Metastases free survival [ Time Frame: up to 5 years or loss of follow-up ]
    takes account of any site of relapse outside of the PTV

  5. Overall survival [ Time Frame: up to 5 years or loss of follow-up ]
    delay of death of any cause accounted starting from randomization

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
  • Radioresistant tumor according to the limitative list as following:

    • adenoid cystic carcinoma of head and neck (larynx and trachea excluded)
    • soft tissue sarcoma
    • rhabdomyosarcoma
    • retroperitoneal sarcoma
    • osteosarcoma (Ewing excluded)
    • chondrosarcoma (except of skull base)
    • axial skeleton chordoma (except of skull base)
    • angiosarcoma
  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02838602

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Contact: Pascal Pommier, MD (0)4 78 78 51 66 ext +33

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Institut de Cancérologie de la Loire Lucien Neuwirtz Not yet recruiting
St Priest en Jarez, Saint Priest En Jarez, France, 42270
Contact: Nicolas MAGNE         
CRLCC Paul Strauss Not yet recruiting
Strasbourg, Strasbourg., France, 67065
Contact: Georges NOEL      
Institut de Cancérologie de Lorraine Recruiting
Vandœuvre-lès-Nancy, Vandoeuvre-Lès-Nancy, France, 54500
Contact: Guillaume VOGIN      
CHU Amiens - Hôpital Sud Not yet recruiting
Amiens, France, 80000
Contact: Claude KRZISCH         
CLCC François Baclesse Not yet recruiting
Caen, France, 14076
Contact: Juliette THARIAT         
CRLCC Jean Perrin Not yet recruiting
Clermont-Ferrand, France, 63000
Contact: Fanny MARTIN         
CRLCC GF Leclerc Not yet recruiting
Dijon, France, 21000
Contact: Gilles TRUC      
CHU de Grenoble Not yet recruiting
Grenoble, France, 38000
Contact: Camille, Olivier VERRY      
CRLCC Oscar Lambret Not yet recruiting
Lille, France, 59020
Contact: Xavier MIRABEL      
Centre Léon Bérard, 28 Prom. Léa et Napoléon Bullukian Not yet recruiting
Lyon, France, 69008
Contact: Pascal Pommier, MD    (0)4 78 78 51 66 ext +33   
CRLCC Institut Paoli Calmettes Not yet recruiting
Marseille, France, 13009
Contact: Laurence MOUREAU-ZABOTTO      
Institut Régional du Cancer Montpellier Not yet recruiting
Montpellier, France, 34200
Contact: Pierre BOISSELIER         
Centre Antoine-Lacassagne Not yet recruiting
Nice, France, 06189
Contact: Alexander FALK         
Institut Curie Not yet recruiting
Paris, France, 75005
Contact: Rémi DENDALE         
CHU Pitié-Salpétrière Not yet recruiting
Paris, France, 75013
Contact: Loïc FEUVRET      
Hôpital de Haut Lévêque Not yet recruiting
Pessac, France, 33600
Contact: Charles DUPIN         
CRLCC Institut Jean Godinot Not yet recruiting
Reims, France, 51700
Contact: Stéphanie SERVAGI-VERNAT         
CRLCC René Gauducheau Not yet recruiting
Saint-Herblain, France, 44800
Contact: Augustin MERVOYER      
Institut Claudius Regaud Not yet recruiting
Toulouse, France, 31000
Contact: Anne DUCASSOU         
Institut Gustave Roussy Not yet recruiting
Villejuif, France, 94805
Contact: Cécile LE PECHOUX      
Sponsors and Collaborators
Hospices Civils de Lyon
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Principal Investigator: Pascal Pommier, MD Centre Leon Berard

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Responsible Party: Hospices Civils de Lyon Identifier: NCT02838602     History of Changes
Other Study ID Numbers: 2012-760
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
carbon ions therapy
radioresistant tumors
randomized trial
Additional relevant MeSH terms:
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Carcinoma, Adenoid Cystic
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Germ Cell and Embryonal