i-RTCT: Modulation of Anti-tumor T Cell Responses in Cancer Patients Treated by Concomitant Radiochemotherapy
Study Details
Study Description
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)
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Biological samples Blood samples will be collected at baseline, at J15/J20 after RTCT initiation, and then 1 month, 3 months and 12 months after the end of RTCT treatment, and at disease progression if applicable. Tumor tissues will be collected if available. |
Other: Biological samples
blood and tumor tissue sample
|
Outcome Measures
Primary Outcome Measures
- tumor antigen specific T-cell responses [up to 12 months after the end of radiochemotherapy]
tumor antigen specific T-cell responses
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically confirmed NSCLC (Non Small Cell Lung Cancer) or SCLC (small cell lung cancer) OR histologically confirmed Head and neck cancer
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Patient candidate to a first-line concomitant radiochemotherapy
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Written informed consent
Exclusion Criteria:
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Sequential radiochemotherapy, exclusive radiotherapy, or stereotactic radiotherapy
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History of adjuvant radiochemotherapy for cancer treatment
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Patients under immunotherapy, chemotherapy or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed)
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HIV, hepatitis C or B virus
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Patients with any medical or psychiatric condition or disease,
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Patients under guardianship, curatorship or under the protection of justice.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | CHU de Besançon | Besançon | France | 25000 | |
2 | Centre Georges François LECLERC | Dijon | France | 21000 | |
3 | Hôpital Nord Franche-Comté | Montbéliard | France | ||
4 | Institut Jean Godinot | Reims | France |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Besancon
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- API/2016/67