CYRAD: Circulating Immunes Cells, Cytokines and Brain Radiotherapy

Sponsor

Centre Francois Baclesse (Other)

Overall Status

Recruiting

CT.gov ID

NCT05082961

Collaborator

Centre National de la Recherche Scientifique, France (Other), Ligue contre le cancer, France (Other), Fondation de France (Other)

Enrollment

Location

Arms

44.1

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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 (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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Other: Collection of blood samples	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

Circulating Immunes Cells, Cytokines and Brain Radiotherapy

Actual Study Start Date :

Jan 27, 2022

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

CD8+ T-cell count. [up to 3 months]

Secondary Outcome Measures

CD4+ Lymphocytes T count [up to 3 months]
Regulatory T cells [up to 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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, other tumours
Patients undergoing exclusive postoperative radiotherapy with a minimum total dose of 60 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre François Baclesse	Caen		France	14076

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Francois Baclesse

ClinicalTrials.gov Identifier:

NCT05082961

Other Study ID Numbers:

2021-A01862-39

First Posted:

Oct 19, 2021

Last Update Posted:

Apr 1, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Head and Neck Neoplasms

Study Results

No Results Posted as of Apr 1, 2022