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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2016 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT02838602
First received: July 18, 2016
Last updated: NA
Last verified: July 2016
History: No changes posted
  Purpose
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 Intervention Phase
Malignant Tumors as Chordoma, Adenoid Cystic Carcinoma and Sarcoma
Radiation: Carbon ions therapy
Radiation: Advanced external radiotherapy by Xrays or protons
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

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

  • 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


Estimated Enrollment: 250
Study Start Date: November 2016
Estimated Study Completion Date: May 2024
Estimated Primary Completion Date: November 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02838602

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

Locations
France
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    pascal.pommier@lyon.unicancer.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Pascal Pommier, MD Centre Leon Berard
  More Information

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02838602     History of Changes
Other Study ID Numbers: 2012-760 
Study First Received: July 18, 2016
Last Updated: July 18, 2016

Keywords provided by Hospices Civils de Lyon:
carbon ions therapy
radiotherapy
radioresistant tumors
cancer
randomized trial

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Adenoid Cystic
Chordoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal

ClinicalTrials.gov processed this record on February 24, 2017