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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Osteosarcoma, Chordoma, Chondrosarcoma, Ewing Sarcoma

Intervention / Treatment
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* Radiation: Proteus ONE one daily beam
* Radiation: Proteus ONE two daily beam


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1DB<br>One daily Beam treatment | Radiation: Proteus ONE one daily beam<br>* A single daily beam is used, doubling the dose delivered for this treatment incidence.<br>|
| Active Comparator: 2DB<br>Two daily beam goldstandard | Radiation: Proteus ONE two daily beam<br>* two daily beams are used, in accordance with the initial treatment plan and the patient's standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During 2 to 7 weeks of protontherapy treatment and during 5 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determining the effectiveness of proton therapy | Efficacy will be assessed in terms of relapse rate | 5-year follow-up visits | 
| Determining the effectiveness of proton therapy | Efficacy will be assessed in terms of local control by MRI assessment | 5-year follow-up visits | 
| Determining the effectiveness of proton therapy | Efficacy will be assessed in terms of overall survival | 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. | 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. | 2-7 weeks of protontherapy treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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protontherapy