Head and Neck Cancer, Lung Cancer
Conditions
Keywords
immunomonitoring, immune checkpoint, chemoradiation, T cells
Brief summary
The aim of this study is to evaluate modulation of anti-tumor T cell responses in cancer patients treated by concomitant radiochemotherapy (i-RTCT)
Interventions
OTHERBiological samples
blood and tumor tissue sample
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed NSCLC (Non Small Cell Lung Cancer) or SCLC (small cell lung cancer) OR histologically confirmed Head and neck cancer * Patient candidate to a first-line concomitant radiochemotherapy * Written informed consent
Exclusion criteria
* Sequential radiochemotherapy, exclusive radiotherapy, or stereotactic radiotherapy * History of adjuvant radiochemotherapy for cancer treatment * Patients under immunotherapy, chemotherapy or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed) * HIV, hepatitis C or B virus * Patients with any medical or psychiatric condition or disease, * Patients under guardianship, curatorship or under the protection of justice.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| tumor antigen specific T-cell responses | up to 12 months after the end of radiochemotherapy | tumor antigen specific T-cell responses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| monitoring of immune checkpoints, immune cell death, immune suppressive cells and T-cell polarisation | up to 12 months after the end of radiochemotherapy | monitoring of immune checkpoints, immune cell death, immune suppressive cells and T-cell polarisation |
| Progression free survival | date of first progression of the disease (within 2 year after the initiation of the treatment)] | time interval between the date of initiation of treatment and the date of first progression (local, remote \[extent of the disease by RECIST v1.1\] second cancer) or death from any cause |
| overall survival | date of death from any cause (within 2 years after the initiation of the treatment) | time between the date of initiation of treatment and the date of death from any cause |
| Quality of life related to health measured by EORTC-QLQC30 | from the inclusion to patient death, up to 1 year | Quality of life related to health measured by EORTC-QLQC30 |
Countries
France
Outcome results
None listed