Circulating Immunes Cells, Cytokines and Brain Radiotherapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Francois Baclesse

About this trial

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\Ф), 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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Collection of blood samples

    Other intervention

    Samples to evaluate the circulating CD8+ T cell count.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: X-ray photon therapy + biological samplesOther 1 intervention
Group B: Protontherapy + biological samplesOther 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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Centre Francois Baclesse

Lead sponsor

Centre National de la Recherche Scientifique, France

Collaborator

Ligue contre le cancer, France

Collaborator

Fondation de France

Collaborator