An interventional study of Proteus ONE one daily beam and Proteus ONE two daily beam in Chordoma, Chondrosarcoma and Ewing Sarcoma, sponsored by Centre Antoine Lacassagne. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-25.
Sponsored by Centre Antoine Lacassagne · Not applicable, Interventional, and Treatment
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.
68 studies on the registry are indexed under Chordoma; 15 are open to participants now.
This study's planned enrollment of 106 is above the median of 38 across 50 interventional studies indexed under Chordoma.
Browse Chordoma studies →Centre Antoine Lacassagne is the lead sponsor of 66 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One daily Beam treatment
Radiation: Proteus ONE one daily beam
Two daily beam goldstandard
Radiation: Proteus ONE two daily beam
A single daily beam is used, doubling the dose delivered for this treatment incidence.
two daily beams are used, in accordance with the initial treatment plan and the patient's standard of care
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).
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.
Time frame: During 2 to 7 weeks of protontherapy treatment and during 5 years follow-up
Determining the effectiveness of proton therapy
Efficacy will be assessed in terms of relapse rate
Time frame: 5-year follow-up visits
Determining the effectiveness of proton therapy
Efficacy will be assessed in terms of local control by MRI assessment
Time frame: 5-year follow-up visits
Determining the effectiveness of proton therapy
Efficacy will be assessed in terms of overall survival
Time frame: 5 years follow-up
Quality of life assessment
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.
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 savings will be assessed by measuring the time taken for door-to-door proton therapy treatment sessions.
Time frame: 2-7 weeks of protontherapy treatment
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2023 (actual). Primary completion is estimated for Sep 2026, 35 months after the start.
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Centre Antoine Lacassagne