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

Not Applicable

Recruiting

• Conditions: Head and Neck Cancer; Lung Cancer
• Interventions: Other: Biological samples

• 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

Arm && Interventions

Group	Intervention	Description
Biological samples	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.

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