CYRAD: a translational study assessing immune response to radiotherapy by photons or protons in postoperative head and neck cancer patients through circulating leukocyte subpopulations and cytokine levels.


Journal

BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800

Informations de publication

Date de publication:
05 Oct 2024
Historique:
received: 21 05 2024
accepted: 27 09 2024
medline: 6 10 2024
pubmed: 6 10 2024
entrez: 5 10 2024
Statut: epublish

Résumé

Radiotherapy has both immunostimulant and immunosuppressive effects, particularly in radiation-induced lymphopenia. Proton therapy has demonstrated potential in mitigating this lymphopenia, yet the mechanisms by which different types of radiation affect the immune system function are not fully characterized. The Circulating Immunes Cells, Cytokines and Brain Radiotherapy (CYRAD) trial aims to compare the effects of postoperative X-ray and proton radiotherapy on circulating leukocyte subpopulations and cytokine levels in patients with head and neck (CNS and ear nose throat) cancer. CYRAD is a prospective, non-randomized, single-center non interventional study assessing changes in the circulating leukocyte subpopulations and cytokine levels in head and neck cancer patients receiving X-ray or proton radiotherapy following tumor resection. Dosimetry parameters, including dose deposited to organs-at-risk such as the blood and cervical lymph nodes, are computed. Participants undergo 29 to 35 radiotherapy sessions over 40 to 50 days, followed by a 3-month follow-up. Blood samples are collected before starting radiotherapy (baseline), before the 11th (D15) and 30th sessions (D40), and three months after completing radiotherapy. The study will be conducted with 40 patients, in 2 groups of 20 patients per modality of radiotherapy (proton therapy and photon therapy). Statistical analyses will assess the absolute and relative relationship between variations (depletion, recovery) in immune cells, biomarkers, dosimetry parameters and early outcomes. Previous research has primarily focused on radiation-induced lymphopenia, paying less attention to the specific impacts of radiation on different lymphoid and myeloid cell types. Early studies indicate that X-ray and proton irradiation may lead to divergent outcomes in leukocyte subpopulations within the bloodstream. Based on these preliminary findings, this study aims to refine our understanding of how proton therapy can better preserve immune function in postoperative (macroscopic tumor-free) head and neck cancer patients, potentially improving treatment outcomes. Version 2.1 dated from January 18, 2023. The CYRAD trial is registered from October 19, 2021, at the US National Library of Medicine, ClinicalTrials.gov ID NCT05082961.

Sections du résumé

BACKGROUND BACKGROUND
Radiotherapy has both immunostimulant and immunosuppressive effects, particularly in radiation-induced lymphopenia. Proton therapy has demonstrated potential in mitigating this lymphopenia, yet the mechanisms by which different types of radiation affect the immune system function are not fully characterized. The Circulating Immunes Cells, Cytokines and Brain Radiotherapy (CYRAD) trial aims to compare the effects of postoperative X-ray and proton radiotherapy on circulating leukocyte subpopulations and cytokine levels in patients with head and neck (CNS and ear nose throat) cancer.
METHODS METHODS
CYRAD is a prospective, non-randomized, single-center non interventional study assessing changes in the circulating leukocyte subpopulations and cytokine levels in head and neck cancer patients receiving X-ray or proton radiotherapy following tumor resection. Dosimetry parameters, including dose deposited to organs-at-risk such as the blood and cervical lymph nodes, are computed. Participants undergo 29 to 35 radiotherapy sessions over 40 to 50 days, followed by a 3-month follow-up. Blood samples are collected before starting radiotherapy (baseline), before the 11th (D15) and 30th sessions (D40), and three months after completing radiotherapy. The study will be conducted with 40 patients, in 2 groups of 20 patients per modality of radiotherapy (proton therapy and photon therapy). Statistical analyses will assess the absolute and relative relationship between variations (depletion, recovery) in immune cells, biomarkers, dosimetry parameters and early outcomes.
DISCUSSION CONCLUSIONS
Previous research has primarily focused on radiation-induced lymphopenia, paying less attention to the specific impacts of radiation on different lymphoid and myeloid cell types. Early studies indicate that X-ray and proton irradiation may lead to divergent outcomes in leukocyte subpopulations within the bloodstream. Based on these preliminary findings, this study aims to refine our understanding of how proton therapy can better preserve immune function in postoperative (macroscopic tumor-free) head and neck cancer patients, potentially improving treatment outcomes.
PROTOCOL VERSION METHODS
Version 2.1 dated from January 18, 2023.
TRIAL REGISTRATION BACKGROUND
The CYRAD trial is registered from October 19, 2021, at the US National Library of Medicine, ClinicalTrials.gov ID NCT05082961.

Identifiants

pubmed: 39369231
doi: 10.1186/s12885-024-13002-1
pii: 10.1186/s12885-024-13002-1
doi:

Substances chimiques

Cytokines 0

Banques de données

ClinicalTrials.gov
['NCT05082961']

Types de publication

Journal Article Clinical Trial Protocol

Langues

eng

Sous-ensembles de citation

IM

Pagination

1230

Subventions

Organisme : ligue contre le cancer, France
ID : 2021-A01862-39
Organisme : ligue contre le cancer, France
ID : 2021-A01862-39

Informations de copyright

© 2024. The Author(s).

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Auteurs

Juliette Thariat (J)

Department of Radiation Oncology, Comprehensive Cancer Centre François Baclesse, Caen, Normandy, France. jthariat@gmail.com.
Laboratoire de physique corpusculaire, UMR6534 IN2P3/ENSICAEN, France-Normandie Université, France. jthariat@gmail.com.

Thao-Nguyen Pham (TN)

Laboratoire de physique corpusculaire, UMR6534 IN2P3/ENSICAEN, France-Normandie Université, France.
Université de Caen Normandie, CNRS, Normandie Université, ISTCT UMR6030, GIP CYCERON, Caen, F-14000, France.

Julie Coupey (J)

Université de Caen Normandie, CNRS, Normandie Université, ISTCT UMR6030, GIP CYCERON, Caen, F-14000, France.

Benedicte Clarisse (B)

Clinical Research Department, Comprehensive Cancer Centre François Baclesse, Caen, Normandy, France.

Jean-Michel Grellard (JM)

Clinical Research Department, Comprehensive Cancer Centre François Baclesse, Caen, Normandy, France.

Nathalie Rousseau (N)

TCNB, Tumorothèque de Caen, Caen, Normandy, France.

Mathieu Césaire (M)

Department of Radiation Oncology, Comprehensive Cancer Centre François Baclesse, Caen, Normandy, France.

Samuel Valable (S)

Université de Caen Normandie, CNRS, Normandie Université, ISTCT UMR6030, GIP CYCERON, Caen, F-14000, France.

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