Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy
- Conditions
- ChondrosarcomaEwing SarcomaChordomaOsteosarcoma
- Interventions
- Radiation: Proteus ONE one daily beamRadiation: Proteus ONE two daily beam
- Registration Number
- NCT06029218
- Lead Sponsor
- Centre Antoine Lacassagne
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 106
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1DB Proteus ONE one daily beam One daily Beam treatment 2DB Proteus ONE two daily beam Two daily beam goldstandard
- Primary Outcome Measures
Name Time Method 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). 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 Outcome Measures
Name Time Method Evaluate the time saving between the two arms 1DB and 2DB 2-7 weeks of protontherapy treatment Time savings will be assessed by measuring the time taken for door-to-door proton therapy treatment sessions.
Determining the effectiveness of proton therapy 5 years follow-up Efficacy will be assessed in terms of overall survival
Quality of life assessment 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.
Trial Locations
- Locations (1)
Centre Antoine lacassagne
🇫🇷Nice, France