NCT06029218 Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy
| NCT ID | NCT06029218 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Antoine Lacassagne |
| Condition | Chordoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 106 participants |
| Start Date | 2023-09-13 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 106 participants in total. It began in 2023-09-13 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Thanks to the intrinsic qualities of the proton beam, proton therapy will reduce adverse effects of irradiation. The Proteus®One is the latest generation of proton therapy equipment, enabling the Centre Antoine Lacassagne to expand its range of treatments by carrying out new proton therapy treatments. It has an innovative compact isocentric rotating head (Gantry) that allows the radiation beam to be directed at different angles around the patient. In some cases, two beams are used to treat tumours, and by convention, both beams are delivered during the same session. However, it is necessary to position the patient before each beam, which is time-consuming because 2 beams have to be positioned very precisely each day. The aim of this study is therefore to assess the toxicity of proton therapy delivered by a single daily beam compared with proton therapy delivered by two daily beams, which is the conventional technique.
Eligibility Criteria
Inclusion Criteria: * Chordoma, chondrosarcoma of the skull base and spine, Ewing's sarcoma, and osteosarcoma meeting the criteria for treatment by proton therapy * Tumour requiring 2 beams * MRI less than one month old * PS 0-2. * Patient who has read the patient information note and signed the consent form. * Patient with healthcare insurance cover. * Age over 18 years. * For women of childbearing age, negative urine pregnancy test and effective contraception in place for the duration of treatment and for six months following the end of treatment. Exclusion Criteria: * Persons deprived of their liberty or under guardianship. * Unable to undergo the medical follow-up of the clinical investigation for geographical, social or psychological reasons. * Patient eligible for symptom reduction surgery Vulnerable populations and participants defined in Articles 64 to 68 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06029218 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chordoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06029218 currently recruiting?
Yes, NCT06029218 is actively recruiting participants. Contact the research team at clement.devic@nice.unicancer.fr for enrollment information.
Where is the NCT06029218 trial being conducted?
This trial is being conducted at Nice, France.
Who is sponsoring the NCT06029218 clinical trial?
NCT06029218 is sponsored by Centre Antoine Lacassagne. The trial plans to enroll 106 participants.