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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • 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 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:
          • Loïc 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

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
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

What is the study measuring?

Primary Outcome Measures

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

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

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Pascal POMMIER, MD, Centre Leon Berard

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)

December 23, 2017

Primary Completion (Anticipated)

December 23, 2026

Study Completion (Anticipated)

December 23, 2026

Study Registration Dates

First Submitted

July 18, 2016

First Submitted That Met QC Criteria

July 18, 2016

First Posted (Estimate)

July 20, 2016

Study Record Updates

Last Update Posted (Actual)

September 2, 2021

Last Update Submitted That Met QC Criteria

September 1, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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