Circulating Immunes Cells, Cytokines and Brain Radiotherapy

Head and Neck Cancer Clinical Trial

— CYRAD  

Official title:

Circulating Immunes Cells, Cytokines and Brain Radiotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05082961
• Other study ID #: 2021-A01862-39
• Status: Recruiting
• Phase: N/A
• Start date: January 27, 2022
• Est. completion date: October 2025

Study information

• Verified date: July 2023
• Source: Centre Francois Baclesse
• Contact: Mathieu CESAIRE, MD
• Phone: +33 (0)2 31 45 50 20
• Email: m.cesaire[@]baclesse.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• Collection of blood samples
Samples to evaluate the circulating CD8+ T cell count.

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen

Sponsors (4)

Lead Sponsor	Collaborator
Centre Francois Baclesse	Centre National de la Recherche Scientifique, France, Fondation de France, Ligue contre le cancer, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD8+ T-cell count.		up to 3 months
Secondary	CD4+ Lymphocytes T count		up to 3 months
Secondary	Regulatory T cells		up to 3 months