NCT06029218Recruiting
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 : Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy
Source: ClinicalTrials.gov · Last updated 25 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 106 (estimated)
- First submitted
- 25 Jul 2023
- Start date
- 13 Sept 2023
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Centre Antoine Lacassagne
- Diseases
- Sarcoma
- NCT number
- NCT06029218
What you commit to
- Study type: Interventional
- Planned participants: 106
- From 13 Sept 2023 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.