Clinical trial NCT05082961: Circulating Immunes Cells, Cytokines and Brain Radiotherapy
Official title: Circulating Immunes Cells, Cytokines and Brain Radiotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
Collaborators: name: Centre National de la Recherche Scientifique, France
name: Ligue contre le cancer, France
name: Fondation de France
First posted: 2021-10-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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\&#1060;), 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

Primary outcomes:
measure: CD8+ T-cell count.
timeFrame: up to 3 months
Secondary outcomes:
measure: CD4+ Lymphocytes T count
timeFrame: up to 3 months
measure: Regulatory T cells
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
Study officials:
References: