Actively Recruiting
Circulating Immunes Cells, Cytokines and Brain Radiotherapy
Led by Centre Francois Baclesse · Updated on 2024-12-11
40
Participants Needed
1
Research Sites
348 weeks
Total Duration
On this page
Sponsors
C
Centre Francois Baclesse
Lead Sponsor
C
Centre National de la Recherche Scientifique, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Circulating Immunes Cells, Cytokines and Brain Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients older than 18 years
- Diagnosed with head and neck cancer (upper aerodigestive tract, cavum, facial sinus, skull base, brain) and operated
- Surgery performed for complete tumor removal or with microscopic residue (R1)
- Any histology including squamous cell carcinoma, undifferentiated carcinoma of nasopharyngeal type, adenocarcinoma, adenoid cystic carcinoma, chordoma, chondrosarcoma, meningioma, or other tumors
- Undergoing exclusive postoperative radiotherapy with at least 54 Gy of X-ray photon radiation or equivalent proton radiation
- Affiliated with a social security scheme
- Signed informed consent before any study-related procedure
You will not qualify if you...
- Macroscopic postoperative tumor residue (R2)
- Previous cancer within 5 years except treated basal cell skin carcinoma and treated cervical cancer
- Previous radiotherapy except brachytherapy of cervix or prostate
- Concomitant chemotherapy or systemic oncological treatment (cetuximab) with radiotherapy
- Long-term immunosuppressive or corticosteroid therapy
- Patient deprived of liberty or under guardianship, or protected adult
- Unable to undergo trial monitoring due to geographical, social, or psychological reasons
- Pregnant or breastfeeding women
- Emergency situations
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centre François Baclesse
Caen, France, 14076
Actively Recruiting
Research Team
M
Mathieu CESAIRE, MD
CONTACT
J
Jean-Michel GRELLARD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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