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

NCT03117946 | Completed

• 1 other identifier: API/2016/67
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 4

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)

Conditions

Lung Cancer; Head and Neck Cancer

Keywords

immunomonitoring; immune checkpoint; chemoradiation; T cells

Outcome Measures

Primary Outcomes (1)

• tumor antigen specific T-cell responses

  tumor antigen specific T-cell responses

  up to 12 months after the end of radiochemotherapy

Secondary Outcomes (4)

• monitoring of immune checkpoints, immune cell death, immune suppressive cells and T-cell polarisation

  up to 12 months after the end of radiochemotherapy

• Progression free survival

  date of first progression of the disease (within 2 year after the initiation of the treatment)]

• overall survival

  date of death from any cause (within 2 years after the initiation of the treatment)

• Quality of life related to health measured by EORTC-QLQC30

  from the inclusion to patient death, up to 1 year

Study Arms (1)

Biological samples

EXPERIMENTAL

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

Interventions

Biological samples OTHER

blood and tumor tissue sample

Biological samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (4)

CHU de Besançon

Besançon, France, 25000, France

Location

Centre Georges François LECLERC

Dijon, 21000, France

Location

Hôpital Nord Franche-Comté

Montbéliard, France

Location

Institut Jean Godinot

Reims, France

Location

MeSH Terms

Conditions

Lung Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 18, 2017
• Study Start: May 29, 2017
• Primary Completion: August 17, 2023
• Study Completion: January 9, 2025
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

FR (4)