Circulating Immunes Cells, Cytokines and Brain Radiotherapy

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Circulating Immunes Cells, Cytokines and Brain Radiotherapy

Study Purpose

Patients with malignant tumours of the cephalic pole have a poor prognosis, despite a wide range of treatments. prognosis despite a large therapeutic arsenal. Among this arsenal, radiotherapy (RT) is one of the standard treatments for these tumours. However, this treatment can cause damage to the surrounding healthy tissue, has limited efficacy in hypoxic However, this treatment can cause damage to the surrounding healthy tissue, has limited efficacy in hypoxic tissue and can promote pro-tumour inflammation. In these circumstances, hadrontherapy, which uses charged heavy particles, such as protons or carbon ions, is the preferred treatment. protons or carbon ions, seems more appropriate for the treatment of these tumours. However, although inflammation plays a major role in tumour development and tumour development and therapeutic response, few studies have evaluated the immune response response after proton therapy (PT) and carbon therapy (CT). The objective of this project is to study the effect of hadrontherapy on resident/circulating inflammation after brain irradiation. brain irradiation. In a first step, the impact of different PT and CT TEL on macrophages (MФ), the most abundant immune cells in malignant solid tumours, will be evaluated in vitro. malignant solid tumours, will be evaluated in vitro. In a second step, the evolution of circulating leukocytes after brain irradiation with X-rays or protons will be studied in vivo in rodents and patients. rodent and patient. In this project, we propose to study for the first time the inflammatory response after hadrontherapy in the context of a cephalic tumour. cephalic tumour. These results will allow a better understanding of the biological response response following PT and CT with the aim of optimising RT and potentially and potentially translate these data to the clinic.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patients > 18 years.

- Head and neck cancer: (upper aerodigestive tract, cavum, facial sinus, skull base, brain) operated.

- Surgery for complete tumour resection or with microscopic residue R1.

- All possible histologies: squamous cell carcinoma, undifferentiated carcinoma of the nasopharyngeal type (UCNT), adenocarcinoma, adenoid cystic carcinoma, chordoma, chondrosarcoma,meningioma other tumours.

- Patients undergoing exclusive postoperative radiotherapy with a minimum total dose of 54 Gy of X-ray photon radiation or equivalent proton radiation.

- Patient affiliated to a social security scheme.

- Signature of the informed consent before any specific procedure related to the study.

Exclusion Criteria:

- Macroscopic postoperative tumour residue R2.

- Previous cancer within 5 years (except treated basal cell skin carcinoma and treated cervical cancer).

- Previous radiotherapy (except brachytherapy of the cervix or prostate) - Chemotherapy or other systemic oncological treatment (cetuximab) concomitant with radiotherapy.

- Long-term immunosuppressive or corticosteroid therapy.

- Patient deprived of liberty or under guardianship, protected adult.

- Patient unable to undergo trial monitoring for geographical, social or psychopathological reasons.

- Pregnant or breastfeeding woman.

- Emergency situations

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05082961
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Centre Francois Baclesse
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Head and Neck Cancer

Arms & Interventions

Arms

Other: X-ray photon therapy + biological samples

Other: Protontherapy + biological samples

Interventions

Other: - Collection of blood samples

Samples to evaluate the circulating CD8+ T cell count.

Contact a Trial Team

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