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

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

Not applicable Interventional Hospices Civils de Lyon · NCT02838602

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

PhaseNot applicable
Study typeInterventional
Enrollment250 (estimated)
Ages18 Years and up
SexAll
SponsorHospices Civils de Lyon Academic / other
Drugs / interventionschemotherapy, radiation
Locations21 sites (Amiens and 20 other locations)
Trial IDNCT02838602 on ClinicalTrials.gov

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.

Who should consider this trial

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

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

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

Eligibility criteria

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 this trial is running

Amiens and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Malignant Tumors as Chordoma, Adenoid Cystic Carcinoma and Sarcomacarbon ions therapyradiotherapyradioresistant tumorscancerrandomized trial
Last reviewed 2026-06-13 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.