- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05082961
Circulating Immunes Cells, Cytokines and Brain Radiotherapy (CYRAD)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mathieu CESAIRE, MD
- Phone Number: +33 (0)2 31 45 50 20
- Email: m.cesaire@baclesse.unicancer.fr
Study Contact Backup
- Name: Jean-Michel GRELLARD
- Phone Number: +33 (0)2 31 45 50 50
- Email: jm.grellard@baclesse.unicancer.fr
Study Locations
-
-
-
Caen, France, 14076
- Recruiting
- Centre Francois Baclesse
-
Sub-Investigator:
- Juliette THARIAT, PhD
-
Contact:
- Mathieu Cesaire, MD
-
Principal Investigator:
- Mathieu Cesaire, MD
-
Sub-Investigator:
- Carmen Florescu, MD
-
Sub-Investigator:
- Fernand Missohou, MD
-
Sub-Investigator:
- Julien GEFFRELOT, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: X-ray photon therapy + biological samples
|
Samples to evaluate the circulating CD8+ T cell count.
|
Other: Protontherapy + biological samples
|
Samples to evaluate the circulating CD8+ T cell count.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CD8+ T-cell count.
Time Frame: up to 3 months
|
up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CD4+ Lymphocytes T count
Time Frame: up to 3 months
|
up to 3 months
|
Regulatory T cells
Time Frame: up to 3 months
|
up to 3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-A01862-39
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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