NCT05082961 Circulating Immunes Cells, Cytokines and Brain Radiotherapy
| NCT ID | NCT05082961 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Francois Baclesse |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-01-27 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2022-01-27 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 (M\Ф), 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05082961 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05082961 currently recruiting?
Yes, NCT05082961 is actively recruiting participants. Contact the research team at m.cesaire@baclesse.unicancer.fr for enrollment information.
Where is the NCT05082961 trial being conducted?
This trial is being conducted at Caen, France.
Who is sponsoring the NCT05082961 clinical trial?
NCT05082961 is sponsored by Centre Francois Baclesse. The trial plans to enroll 40 participants.
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