Circulating Immunes Cells, Cytokines and Brain Radiotherapy (CYRAD)
Primary Purpose
Head and Neck Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Collection of blood samples
Sponsored by
About this trial
This is an interventional other trial for Head and Neck Cancer
Eligibility Criteria
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, 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
Sites / Locations
- Centre François BaclesseRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
X-ray photon therapy + biological samples
Protontherapy + biological samples
Arm Description
Outcomes
Primary Outcome Measures
CD8+ T-cell count.
Secondary Outcome Measures
CD4+ Lymphocytes T count
Regulatory T cells
Full Information
NCT ID
NCT05082961
First Posted
October 6, 2021
Last Updated
July 31, 2023
Sponsor
Centre Francois Baclesse
Collaborators
Centre National de la Recherche Scientifique, France, Ligue contre le cancer, France, Fondation de France
1. Study Identification
Unique Protocol Identification Number
NCT05082961
Brief Title
Circulating Immunes Cells, Cytokines and Brain Radiotherapy
Acronym
CYRAD
Official Title
Circulating Immunes Cells, Cytokines and Brain Radiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 27, 2022 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
Collaborators
Centre National de la Recherche Scientifique, France, Ligue contre le cancer, France, Fondation de France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
X-ray photon therapy + biological samples
Arm Type
Other
Arm Title
Protontherapy + biological samples
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Collection of blood samples
Intervention Description
Samples to evaluate the circulating CD8+ T cell count.
Primary Outcome Measure Information:
Title
CD8+ T-cell count.
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
CD4+ Lymphocytes T count
Time Frame
up to 3 months
Title
Regulatory T cells
Time Frame
up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mathieu CESAIRE, MD
Phone
+33 (0)2 31 45 50 20
Email
m.cesaire@baclesse.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Michel GRELLARD
Phone
+33 (0)2 31 45 50 50
Email
jm.grellard@baclesse.unicancer.fr
Facility Information:
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu Cesaire, MD
First Name & Middle Initial & Last Name & Degree
Mathieu Cesaire, MD
First Name & Middle Initial & Last Name & Degree
Juliette Thariat, PhD
First Name & Middle Initial & Last Name & Degree
Carmen Florescu, MD
First Name & Middle Initial & Last Name & Degree
Julien Geffrelot, MD
First Name & Middle Initial & Last Name & Degree
Fernand Missohou, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Circulating Immunes Cells, Cytokines and Brain Radiotherapy
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