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

September 1, 2021 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: up to 5 years or loss of follow-up
Starting point for PFS measurement is the randomization date
up to 5 years or loss of follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Grades of the CTCAE-V4.02 classification
Time Frame: up to 5 years or loss of follow-up
Tolerance
up to 5 years or loss of follow-up
EQ-5D questionnaire
Time Frame: up to 5 years or loss of follow-up
Quality of life
up to 5 years or loss of follow-up
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)
up to 5 years or loss of follow-up
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
up to 5 years or loss of follow-up
Overall survival
Time Frame: up to 5 years or loss of follow-up
delay of death of any cause accounted starting from randomization
up to 5 years or loss of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pascal POMMIER, MD, Centre Léon Bérard

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 23, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2026

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 23, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2012-760

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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