Comparing single vs double beam proton therapy for certain tumors
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
This study is testing whether using one beam of proton therapy is just as effective and safer than using two beams for patients with certain types of tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Antoine Lacassagne Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Nice) |
| Trial ID | NCT06029218 on ClinicalTrials.gov |
What this trial studies
This study evaluates the toxicity and efficacy of proton therapy delivered using either one or two beams for patients with chordoma, chondrosarcoma, Ewing sarcoma, and osteosarcoma. The Proteus®One system allows for precise targeting of tumors with reduced adverse effects compared to traditional radiation methods. By assessing the differences in patient outcomes between the two approaches, the study aims to determine if a single beam can be as effective as the conventional two-beam method while minimizing treatment time and patient discomfort.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with specific tumors requiring proton therapy and who meet the study's inclusion criteria.
Not a fit: Patients who are not eligible for proton therapy or those requiring symptom reduction surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more efficient and less toxic treatment option for patients with specific types of tumors.
How similar studies have performed: While proton therapy is established, this specific comparison of single vs double beam delivery is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nice
- Centre Antoine lacassagne — Nice, France (Recruiting)
Study contacts
- Study coordinator: Clement DEVIC, PhD
- Email: clement.devic@nice.unicancer.fr
- Phone: 0492031511
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.