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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
106
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
Centre Antoine lacassagne
Nice, France
RECRUITINGTo 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
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