Back to resultsAnalysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy (P1V2)
Primary Purpose
Chordoma, Chondrosarcoma, Ewing Sarcoma
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Proteus ONE one daily beam
Proteus ONE two daily beam
Sponsored by
About this trial
This is an interventional treatment trial for Chordoma focused on measuring protontherapy
Eligibility 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.
Sites / Locations
- Centre Antoine lacassagneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1DB
2DB
Arm Description
One daily Beam treatment
Two daily beam goldstandard
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Determining the effectiveness of proton therapy
Efficacy will be assessed in terms of relapse rate
Determining the effectiveness of proton therapy
Efficacy will be assessed in terms of local control by MRI assessment
Determining the effectiveness of proton therapy
Efficacy will be assessed in terms of overall survival
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.
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.
Full Information
NCT ID
NCT06029218
First Posted
July 25, 2023
Last Updated
September 14, 2023
Sponsor
Centre Antoine Lacassagne
1. Study Identification
Unique Protocol Identification Number
NCT06029218
Brief Title
Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy
Acronym
P1V2
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2023 (Actual)
Primary Completion Date
September 1, 2026 (Anticipated)
Study Completion Date
October 1, 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Antoine Lacassagne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chordoma, Chondrosarcoma, Ewing Sarcoma, Osteosarcoma
Keywords
protontherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1DB
Arm Type
Experimental
Arm Description
One daily Beam treatment
Arm Title
2DB
Arm Type
Active Comparator
Arm Description
Two daily beam goldstandard
Intervention Type
Radiation
Intervention Name(s)
Proteus ONE one daily beam
Intervention Description
A single daily beam is used, doubling the dose delivered for this treatment incidence.
Intervention Type
Radiation
Intervention Name(s)
Proteus ONE two daily beam
Intervention Description
two daily beams are used, in accordance with the initial treatment plan and the patient's standard of care
Primary Outcome Measure Information:
Title
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).
Description
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
Secondary Outcome Measure Information:
Title
Determining the effectiveness of proton therapy
Description
Efficacy will be assessed in terms of relapse rate
Time Frame
5-year follow-up visits
Title
Determining the effectiveness of proton therapy
Description
Efficacy will be assessed in terms of local control by MRI assessment
Time Frame
5-year follow-up visits
Title
Determining the effectiveness of proton therapy
Description
Efficacy will be assessed in terms of overall survival
Time Frame
5 years follow-up
Title
Quality of life assessment
Description
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
Title
Evaluate the time saving between the two arms 1DB and 2DB
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clement DEVIC, PhD
Phone
0033492031511
Email
clement.devic@nice.unicancer.fr
Facility Information:
Facility Name
Centre Antoine lacassagne
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BONDIAU Pierre Yves
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy
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