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NCT Number: NCT05082961

Circulating Immunes Cells, Cytokines and Brain Radiotherapy

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre François Baclesse

Caen, 14076, France

Location status: Recruiting

Location contact

Carmen Florescu, MD

CONTACT

Fernand Missohou, MD

CONTACT

Julien Geffrelot, MD

CONTACT

Juliette Thariat, PhD

CONTACT

Mathieu Cesaire, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of blood samples

Other

Samples to evaluate the circulating CD8+ T cell count.

Primary outcomes

  1. CD8+ T-cell count.

    Time frame: up to 3 months

Secondary outcomes

  1. CD4+ Lymphocytes T count

    Time frame: up to 3 months

  2. Regulatory T cells

    Time frame: up to 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Michel GRELLARD

CONTACT

[email protected]

+33 (0)2 31 45 50 50

Mathieu CESAIRE, MD

CONTACT

[email protected]

+33 (0)2 31 45 50 20

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Collaborators

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

Registry information

Acronym: CYRAD

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Oct 19, 2021
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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