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

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ClinicalTrials.gov Identifier: NCT02838602
Recruitment Status : Recruiting
First Posted : July 20, 2016
Last Update Posted : September 2, 2021
Sponsor:
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 : December 23, 2026
Estimated Study Completion Date : December 23, 2026

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Chordoma
MedlinePlus related topics: Adenoids

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 ]
    Tolerance

  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT02838602


Contacts
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Contact: Pascal POMMIER, MD (0)4 78 78 51 66 ext +33 pascal.pommier@lyon.unicancer.fr

Locations
Show Show 21 study locations
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Pascal POMMIER, MD Centre Leon Berard
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02838602    
Other Study ID Numbers: 2012-760
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: September 2, 2021
Last Verified: September 2021

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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
radiotherapy
radioresistant tumors
cancer
randomized trial
Additional relevant MeSH terms:
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Neoplasms
Carcinoma, Adenoid Cystic
Chordoma
Neoplasms by Histologic Type
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Germ Cell and Embryonal