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NCT Number: NCT06029218

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

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.

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Key information

Conditions

Chordoma Chondrosarcoma Ewing Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Osteosarcoma Sarcoma Sarcoma, Ewing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Antoine lacassagne

Nice, 06000, France

Location status: Recruiting

Location contact

BONDIAU Pierre Yves

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

    Assessment of the incidence of grade ≥2 medical device-related toxicities assessed according to CTCAE version 5.0 in each of the two treatment arms.

Secondary outcomes

  1. Determining the effectiveness of proton therapy

    Time frame: 5-year follow-up visits

    Efficacy will be assessed in terms of relapse rate

  2. Determining the effectiveness of proton therapy

    Time frame: 5-year follow-up visits

    Efficacy will be assessed in terms of local control by MRI assessment

  3. Determining the effectiveness of proton therapy

    Time frame: 5 years follow-up

    Efficacy will be assessed in terms of overall survival

  4. Quality of life assessment

    Time frame: During 2-7 weeks of protontherapy treatment and during 5 years follow-up

    Quality of life will be assessed using the EORTC QLQ-C30 scale (Appendix 2), version 3 at the inclusion assessment, at the end-of-treatment visit and at each assessment visit for five years. Version 3.0 of the QLQ-C30 has four-point scales for the items 1 to 28 namely : 1 : "Not a tall", 2 : "A little", 3 : "Quite a bit" and 4 : "Very much." Higher score mean worse outcome. Item 29 and 30 has seven-point scales from 1 : " very bad " to 7 "Excellent". Lower score mean worse outcome.

  5. Evaluate the time saving between the two arms 1DB and 2DB

    Time frame: 2-7 weeks of protontherapy treatment

    Time savings will be assessed by measuring the time taken for door-to-door proton therapy treatment sessions.

Study contacts

Contact information is provided by the study sponsor or research team.

Clement DEVIC, PhD

CONTACT

[email protected]

0492031511

Sponsors and collaborators

Lead sponsor

Centre Antoine Lacassagne

Other

Registry information

Official study 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

Acronym: P1V2

Important dates

Study start
2023
Primary completion
2026
Study completion
2031
First posted
Sep 8, 2023
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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