Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Antoine Lacassagne

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Proteus ONE one daily beam
  • Proteus ONE two daily beam

Treatment groups

106 Participants
are divided into 2 treatment groups

Sponsors and collaborators