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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 : September 2, 2021
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE July 18, 2016
First Posted Date  ICMJE July 20, 2016
Last Update Posted Date September 2, 2021
Actual Study Start Date  ICMJE December 23, 2017
Estimated Primary Completion Date December 23, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2016)
Progression free survival (PFS) [ Time Frame: up to 5 years or loss of follow-up ]
Starting point for PFS measurement is the randomization date
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2016)
  • Grades of the CTCAE-V4.02 classification [ Time Frame: 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
  • 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)
  • 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
  • Overall survival [ Time Frame: up to 5 years or loss of follow-up ]
    delay of death of any cause accounted starting from randomization
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Randomized Carbon Ions vs Standard Radiotherapy for Radioresistant Tumors
Official Title  ICMJE Transnational Randomized Study Comparing Carbon Ions Therapy Versus Conventional Radiotherapy - Including Protontherapy - for the Treatment of Radioresistant Tumors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malignant Tumors as Chordoma, Adenoid Cystic Carcinoma and Sarcoma
Intervention  ICMJE
  • Radiation: Carbon ions therapy
    External radiotherapy by accelerated carbon nucleus in a specialized hadrontherapy center
  • 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
Study Arms  ICMJE
  • Experimental: Carbon ions therapy
    Radical and exclusive carbon ions radiotherapy
    Intervention: Radiation: Carbon ions therapy
  • Active Comparator: Conventional radiotherapy
    Radical radiotherapy by Xrays and / or protons
    Intervention: Radiation: Advanced external radiotherapy by Xrays or protons
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2016)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 23, 2026
Estimated Primary Completion Date December 23, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pascal POMMIER, MD (0)4 78 78 51 66 ext +33
Listed Location Countries  ICMJE France
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02838602
Other Study ID Numbers  ICMJE 2012-760
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pascal POMMIER, MD Centre Leon Berard
PRS Account Hospices Civils de Lyon
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP