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Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy (P1V2)

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ClinicalTrials.gov Identifier: NCT06029218
Recruitment Status : Recruiting
First Posted : September 8, 2023
Last Update Posted : September 15, 2023
Sponsor:
Information provided by (Responsible Party):
Centre Antoine Lacassagne

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chordoma Chondrosarcoma Ewing Sarcoma Osteosarcoma Radiation: Proteus ONE one daily beam Radiation: Proteus ONE two daily beam Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 13, 2023
Estimated Primary Completion Date : September 1, 2026
Estimated Study Completion Date : October 1, 2031

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


Outcome Measures
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Primary Outcome Measures :
  1. 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). [ Time Frame: 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 :
  1. Determining the effectiveness of proton therapy [ Time Frame: 5-year follow-up visits ]
    Efficacy will be assessed in terms of relapse rate

  2. Determining the effectiveness of proton therapy [ Time Frame: 5-year follow-up visits ]
    Efficacy will be assessed in terms of local control by MRI assessment

  3. Determining the effectiveness of proton therapy [ Time Frame: 5 years follow-up ]
    Efficacy will be assessed in terms of overall survival

  4. Quality of life assessment [ Time Frame: 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.

  5. Evaluate the time saving between the two arms 1DB and 2DB [ Time Frame: 2-7 weeks of protontherapy treatment ]
    Time savings will be assessed by measuring the time taken for door-to-door proton therapy treatment sessions.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06029218


Contacts
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Contact: Clement DEVIC, PhD 0033492031511 clement.devic@nice.unicancer.fr

Locations
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France
Centre Antoine lacassagne Recruiting
Nice, France, 06000
Contact: BONDIAU Pierre Yves         
Sponsors and Collaborators
Centre Antoine Lacassagne
More Information
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Responsible Party: Centre Antoine Lacassagne
ClinicalTrials.gov Identifier: NCT06029218    
Other Study ID Numbers: 2022/72
First Posted: September 8, 2023    Key Record Dates
Last Update Posted: September 15, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Antoine Lacassagne:
protontherapy
Additional relevant MeSH terms:
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Osteosarcoma
Sarcoma, Ewing
Chondrosarcoma
Chordoma
Sarcoma
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Germ Cell and Embryonal