NCT05082961Recruiting
Circulating Immunes Cells, Cytokines and Brain Radiotherapy
Source: ClinicalTrials.gov · Last updated 11 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 6 Oct 2021
- Start date
- 27 Jan 2022
- Primary completion date
- Apr 2028
- Lead sponsor
- Centre Francois Baclesse
- Diseases
- Head and neck cancer
- NCT number
- NCT05082961
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 27 Jan 2022 to the primary completion date, Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Previous cancer within 5 years (except treated basal cell skin carcinoma and treated cervical cancer).
Other
- Macroscopic postoperative tumour residue R2
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre François Baclesse Coordinator of this site? Confirm its status | Caen | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.