- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06029218
Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy (P1V2)
September 14, 2023 updated by: Centre Antoine Lacassagne
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
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
106
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clement DEVIC, PhD
- Phone Number: 0033492031511
- Email: clement.devic@nice.unicancer.fr
Study Locations
-
-
-
Nice, France, 06000
- Recruiting
- Centre Antoine Lacassagne
-
Contact:
- BONDIAU Pierre Yves
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1DB
One daily Beam treatment
|
A single daily beam is used, doubling the dose delivered for this treatment incidence.
|
Active Comparator: 2DB
Two daily beam goldstandard
|
two daily beams are used, in accordance with the initial treatment plan and the patient's standard of care
|
What is the study measuring?
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).
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.
|
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
Time Frame: 5-year follow-up visits
|
Efficacy will be assessed in terms of relapse rate
|
5-year follow-up visits
|
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
|
5-year follow-up visits
|
Determining the effectiveness of proton therapy
Time Frame: 5 years follow-up
|
Efficacy will be assessed in terms of overall survival
|
5 years follow-up
|
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.
|
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 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.
|
2-7 weeks of protontherapy treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 13, 2023
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
October 1, 2031
Study Registration Dates
First Submitted
July 25, 2023
First Submitted That Met QC Criteria
September 6, 2023
First Posted (Actual)
September 8, 2023
Study Record Updates
Last Update Posted (Actual)
September 15, 2023
Last Update Submitted That Met QC Criteria
September 14, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/72 (CHULiege)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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