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
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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 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 |
Arm | Intervention/treatment |
---|---|
Experimental: 1DB
One daily Beam treatment
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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
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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 |
- 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.
- Determining the effectiveness of proton therapy [ Time Frame: 5-year follow-up visits ]Efficacy will be assessed in terms of relapse rate
- 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
- Determining the effectiveness of proton therapy [ Time Frame: 5 years follow-up ]Efficacy will be assessed in terms of overall survival
- 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.
- 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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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
Contact: Clement DEVIC, PhD | 0033492031511 | clement.devic@nice.unicancer.fr |
France | |
Centre Antoine lacassagne | Recruiting |
Nice, France, 06000 | |
Contact: BONDIAU Pierre Yves |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
protontherapy |
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 |