Actively Recruiting
Analysis of the Toxicity and Effectiveness of One Daily Beam Versus Two Daily Beams in Proton Therapy for Chordoma, Chondrosarcoma, Ewing Sarcoma, and Osteosarcoma
Led by Centre Antoine Lacassagne · Updated on 2024-09-25
106
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating proton therapy in patients with chordoma, chondrosarcoma, Ewing sarcoma, and osteosarcoma who require two radiation beams for treatment. This study aims to compare the toxicity of proton therapy delivered using a single daily beam versus the conventional approach of two daily beams. The latest Proteus®One proton therapy equipment with a compact rotating gantry enables precise targeting of tumors from different angles, potentially reducing treatment side effects. Participants are randomly assigned to receive either one daily beam, which delivers a doubled dose in each session, or two daily beams delivered according to the standard treatment plan. Both beams are conventionally delivered in the same session but require repositioning the patient before each beam, which takes extra time. This study evaluates whether delivering only one beam daily can maintain treatment effectiveness while reducing toxicity and saving time over the 2 to 7 week treatment period. During the treatment and up to five years of follow-up, patients will be monitored for side effects, quality of life, and treatment effectiveness. Researchers will measure the frequency of toxicities and assess quality of life throughout treatment and follow-up. They will also evaluate the time saved by using a single daily beam. The total participant involvement includes initial treatment and long-term follow-up visits to assess outcomes and safety.
CONDITIONS
Brief Title
Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of chordoma, chondrosarcoma of the skull base or spine, Ewing sarcoma, or osteosarcoma suitable for proton therapy
- Tumor requires treatment with two radiation beams
- MRI scan less than one month old
- Performance status of 0 to 2
- Able to read patient information and sign consent
- Covered by healthcare insurance
- Age over 18 years
- For women of childbearing age, negative urine pregnancy test and effective contraception during treatment and for six months after
You will not qualify if you...
- Persons deprived of liberty or under guardianship
- Unable to attend medical follow-up due to geographical, social, or psychological reasons
- Eligible for symptom reduction surgery
- Vulnerable populations as defined by European regulations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 7 weeks
Participants receive proton therapy using either one daily beam or two daily beams to treat their condition.
Daily visits for treatment over 2 to 7 weeks
Duration - 5 years
Participants are monitored for effectiveness and toxicity of the proton therapy over a 5-year period.
Periodic follow-up visits during 5 years
Trial Site Locations
Total: 1 location
1
Centre Antoine lacassagne
Nice, France, 06000
Actively Recruiting
Research Team
C
Clement DEVIC, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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