ChordomaP1V2NCT06029218
Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy
A study testing Proteus ONE one daily beam and Proteus ONE two daily beam in people with Chordoma and Chondrosarcoma, run by Centre Antoine Lacassagne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chordoma, Chondrosarcoma, Ewing Sarcoma
- What is being tested?
- Proteus ONE one daily beam and Proteus ONE two daily beam
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteFrance
- Study dates
- 13 Sep 2023to 1 Oct 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Antoine lacassagne
Nice, 06000
BONDIAU Pierre Yves, pierre-yves.bondiau@nice.unicancer.fr
About this study
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
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.
- Conditions
- Chordoma, Chondrosarcoma, Ewing Sarcoma, Osteosarcoma
- Being tested
- Proteus ONE one daily beam, Proteus ONE two daily beam
- Keywords
- protontherapy
- Medical subject headings
- Chordoma, Chondrosarcoma, Sarcoma, Ewing, Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proteus ONE one daily beamRadiation
A single daily beam is used, doubling the dose delivered for this treatment incidence.
Proteus ONE two daily beamRadiation
two daily beams are used, in accordance with the initial treatment plan and the patient's standard of care
| Study group | Role | What they receive |
|---|---|---|
| 1DB | Experimental | One daily Beam treatment Receives: Radiation: Proteus ONE one daily beam |
| 2DB | Active comparator | Two daily beam goldstandard Receives: Radiation: Proteus ONE two daily beam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During 2 to 7 weeks of protontherapy treatment and during 5 years follow-up
Secondary outcomes (5)
Determining the effectiveness of proton therapy
Efficacy will be assessed in terms of relapse rate
Measured: 5-year follow-up visits
Determining the effectiveness of proton therapy
Efficacy will be assessed in terms of local control by MRI assessment
Measured: 5-year follow-up visits
Determining the effectiveness of proton therapy
Efficacy will be assessed in terms of overall survival
Measured: 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.
Measured: 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.
Measured: 2-7 weeks of protontherapy treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start13 Sep 2023
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChordomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029218
- Sponsor's protocol ID
- 2022/72
- Acronym
- P1V2
- Status last verified
- Aug 2024
- First submitted
- 25 Jul 2023
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06029218
- Acronym / sponsor ID
- P1V2 / 2022/72
- Conditions
- Chordoma, Chondrosarcoma, Ewing Sarcoma, Osteosarcoma
- Keywords
- protontherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2031 (estimated)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1DB | Experimental | Radiation: Proteus ONE one daily beamOne daily Beam treatment |
| 2DB | Active comparator | Radiation: Proteus ONE two daily beamTwo daily beam goldstandard |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proteus ONE one daily beamA single daily beam is used, doubling the dose delivered for this treatment incidence. | Radiation | 1DB |
| Proteus ONE two daily beamtwo daily beams are used, in accordance with the initial treatment plan and the patient's standard of care | Radiation | 2DB |
Primary outcome
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.
5 secondary outcomes
Determining the effectiveness of proton therapy
Time frame: 5-year follow-up visits
Determining the effectiveness of proton therapy
Time frame: 5-year follow-up visits
Determining the effectiveness of proton therapy
Time frame: 5 years follow-up
Quality of life assessment
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 frame: 2-7 weeks of protontherapy treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proteus ONE one daily beam and Proteus ONE two daily beam in people with Chordoma and Chondrosarcoma, run by Centre Antoine Lacassagne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clement DEVIC, PhD (0492031511, clement.devic@nice.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.