Clinical trial Recruiting at 13 sites Interventional Ages 18 and up

Comparing carbon ion therapy to standard radiotherapy for hard-to-treat tumors

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

Run by Hospices Civils de Lyon · NCT02838602 · Data updated 2026-11-12

This study is testing whether carbon ion therapy can help people with hard-to-treat tumors live longer without their cancer coming back compared to standard radiation treatments.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment250 (estimated)
SponsorHospices Civils de Lyon
Academic / other
Drugs / interventionschemotherapy, radiation
Locations21 sites (Amiens and 20 other locations)
StatusRecruiting
StartedDecember 23, 2017
Main results expectedDecember 23, 2026
Study endsDecember 23, 2026
Registry record updatedSeptember 2, 2021
Trial IDNCT02838602 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with specific unresectable or incompletely resected radioresistant tumors.

Probably not a fit

Patients with severe comorbidities or those who have previously undergone radiation therapy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a transnational prospective randomized comparison of carbon ion therapy versus standard photon or combined photon and proton therapy for patients with unresectable or incompletely resected radioresistant tumors. Eligible tumors include specific types of chordoma, adenoid cystic carcinoma, and sarcomas. The study aims to enroll 250 patients, with a balanced randomization of participants receiving either treatment. The primary endpoint is progression-free survival at five years, with an expected absolute difference of 20% in relapse-free survival.

Why it matters

Potential benefit: If successful, this trial could provide a more effective treatment option for patients with radioresistant tumors.

How similar studies have gone: Other studies have shown promise with carbon ion therapy, suggesting potential benefits in treating radioresistant tumors.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • CHU Amiens - Hôpital Sud
    Amiens, France
    Recruiting
  • Radiothérapie, CLCC François Baclesse
    Caen, France
    Recruiting
  • Radiothérapie, CRLCC GF Leclerc
    Dijon, France
    Recruiting
  • Radiothérapie, Hôpital A. Michallon, CHU de Grenoble
    Grenoble, France
    Recruiting
  • Radiothérapie, CRLCC Oscar Lambret
    Lille, France
    Recruiting
  • Radiothérapie, CRLCC Léon Bérard
    Lyon, France
    Recruiting
Show 15 more locations
  • Radiothérapie, Institut Régional du Cancer Montpellier, ICM Val d'Aurelle
    Montpellier, France
    Recruiting
  • Pôle de radiothérapie, Centre Antoine-Lacassagne
    Nice, France
    Recruiting
  • Radiothérapie, CRLCC Institut Jean Godinot
    Reims, France
    Recruiting
  • Radiothérapie, Institut de Cancérologie de la Loire Lucien Neuwirtz
    Saint-Priest-en-Jarez, France
    Recruiting
  • Radiothérapie, CRLCC Paul Strauss
    Strasbourg, France
    Recruiting
  • Institut universitaire du cancer de Toulouse - Oncopole, Institut Claudius Regaud
    Toulouse, France
    Recruiting
  • Radiothérapie, Institut de Cancérologie de Lorraine Alexis Vautrin
    Vandœuvre-lès-Nancy, France
    Recruiting
  • Radiothérapie, CRLCC Jean Perrin
    Clermont-Ferrand, France
    Not yet recruiting
  • Radiothérapie, CRLCC Institut Paoli Calmettes
    Marseille, France
    Not yet recruiting
  • Radiothérapie, CHU Pitié-Salpétrière
    Paris, France
    Not yet recruiting
  • Institut Curie, site Hôpital de Paris et site d'Orsay (Centre de protonthérapie)
    Paris, France
    Not yet recruiting
  • Radiothérapie, Hôpital de Haut Lévêque, CHU Bordeaux
    Pessac, France
    Not yet recruiting
  • Centre Eugene Marquis
    Rennes, France
    Not yet recruiting
  • Radiothérapie, CRLCC René Gauducheau
    Saint-Herblain, France
    Not yet recruiting
  • Radiothérapie, Institut Gustave Roussy
    Villejuif, France
    Not yet recruiting

Study contacts

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.