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

Sponsor
Centre Antoine Lacassagne
Study ID
NCT06029218
Status
Recruiting
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Conditions

  • Chondrosarcoma
  • Chordoma
  • Ewing Sarcoma
  • Osteosarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Proteus ONE one daily beam — RADIATION
    A single daily beam is used, doubling the dose delivered for this treatment incidence.
  • Proteus ONE two daily beam — RADIATION
    two daily beams are used, in accordance with the initial treatment plan and the patient's standard of care

Study Details

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.

Key Dates

First listed
Sep 8, 2023
Start date
Sep 13, 2023
Status verified
Aug 2024
Primary completion
Sep 1, 2026
Completion
Oct 1, 2031

Study Design

Enrollment
106 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1DB
    One daily Beam treatment
  • Active Comparator: 2DB
    Two daily beam goldstandard

Primary Outcome Measure

To evaluate the frequency of occurrence of toxicities in the group of patients treated with two daily beams (2DB) and in the group of patients treated with one daily beams (1DB). [ Time Frame: During 2 to 7 weeks of protontherapy treatment and during 5 years follow-up ]

Central Contacts

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