Circulating Immunes Cells, Cytokines and Brain Radiotherapy (CYRAD)

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Other: Collection of blood samples

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mathieu CESAIRE, MD; Phone Number: +33 (0)2 31 45 50 20; Email: m.cesaire@baclesse.unicancer.fr
• Study Contact Backup: Name: Jean-Michel GRELLARD; Phone Number: +33 (0)2 31 45 50 50; Email: jm.grellard@baclesse.unicancer.fr

Study Locations

• France
  • Caen, France, 14076
    • Recruiting
    • Centre François Baclesse
    • Contact: Julien GEFFRELOT, MD
    • Contact: Mathieu Cesaire, MD
    • Contact: Fernand Missohou, MD
    • Contact: Juliette Thariat, PhD
    • Contact: Carmen Florescu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: X-ray photon therapy + biological samples	Other: Collection of blood samples; Samples to evaluate the circulating CD8+ T cell count.
Other: Protontherapy + biological samples	Other: Collection of blood samples; Samples to evaluate the circulating CD8+ T cell count.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
CD8+ T-cell count.	up to 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
CD4+ Lymphocytes T count	up to 3 months
Regulatory T cells	up to 3 months

Collaborators and Investigators

• Sponsor: Centre Francois Baclesse
• Collaborators: Ligue contre le cancer, France; Fondation de France; Centre National de la Recherche Scientifique, France

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2022
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: October 6, 2021
• First Submitted That Met QC Criteria: October 6, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: 2021-A01862-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No