Modulation of Anti-tumor T Cell Responses in Cancer Patients Treated by Concomitant Radiochemotherapy

Not Applicable

Recruiting

• Conditions: Head and Neck Cancer; Lung Cancer

• Registration Number: NCT03117946
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-13
• Study First Submitted QC: 2017-04-13
• Study First Posted: 2017-04-18
• Study Start: 2017-05-29
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27
• Primary Completion: 2026-08-29
• Study Completion: 2026-11-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
tumor antigen specific T-cell responses	up to 12 months after the end of radiochemotherapy	tumor antigen specific T-cell responses

Secondary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (4)

CHU de Besançon; 🇫🇷 Besançon, France

Centre Georges François LECLERC; 🇫🇷 Dijon, France

Hôpital Nord Franche-Comté; 🇫🇷 Montbéliard, France

Institut Jean Godinot; 🇫🇷 Reims, France