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Recruiting NCT06029218

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

No phase Interventional Chordoma Chondrosarcoma Ewing Sarcoma Osteosarcoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Proteus ONE one daily beam, Proteus ONE two daily beam.
Who it may be relevant to
Registry conditions: Chordoma, Chondrosarcoma, Ewing Sarcoma, Osteosarcoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (5)
  • Determining the effectiveness of proton therapy [Time frame: 5-year follow-up visits]
  • Determining the effectiveness of proton therapy [Time frame: 5-year follow-up visits]
  • Determining the effectiveness of proton therapy [Time frame: 5 years follow-up]
  • Quality of life assessment [Time frame: During 2-7 weeks of protontherapy treatment and during 5 years follow-up]
  • Evaluate the time saving between the two arms 1DB and 2DB [Time frame: 2-7 weeks of protontherapy treatment]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • Centre Antoine lacassagne — Nice

Identifiers

NCT: NCT06029218 · 2022/72

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗