Status:
RECRUITING
Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy
Lead Sponsor:
Centre Antoine Lacassagne
Conditions:
Chordoma
Chondrosarcoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 Cent...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2031
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT06029218
Start Date
September 13 2023
End Date
October 1 2031
Last Update
September 25 2024
Active Locations (1)
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1
Centre Antoine lacassagne
Nice, France, 06000