Modulation of Anti-tumor T Cell Responses in Cancer Patients Treated by Concomitant Radiochemotherapy (i-RTCT)

December 23, 2024 updated by: Centre Hospitalier Universitaire de Besançon
The aim of this study is to evaluate modulation of anti-tumor T cell responses in cancer patients treated by concomitant radiochemotherapy (i-RTCT)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Besançon, France, 25000
        • Recruiting
        • CHU de Besançon
        • Contact:
        • Principal Investigator:
          • Bernardino DE BARI, PH
      • Dijon, France, 21000
        • Recruiting
        • Centre Georges Francois Leclerc
        • Contact:
          • Etienne MARTIN, Dr
        • Principal Investigator:
          • Etienne MARTIN, Dr
      • Montbéliard, France
        • Recruiting
        • Hôpital Nord Franche-Comté
        • Contact:
          • SUN, Dr
        • Principal Investigator:
          • SUN, Dr
      • Reims, France
        • Recruiting
        • Institut Jean Godinot
        • Contact:
          • Stéphanie SERVAGI VERNAT, Dr
        • Principal Investigator:
          • Stéphanie SERVAGI VERNAT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tumor antigen specific T-cell responses
Time Frame: up to 12 months after the end of radiochemotherapy
tumor antigen specific T-cell responses
up to 12 months after the end of radiochemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 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
date of death from any cause (within 2 years after the initiation of the treatment)
monitoring of immune checkpoints, immune cell death, immune suppressive cells and T-cell polarisation
Time Frame: up to 12 months after the end of radiochemotherapy
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
Time Frame: 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
date of first progression of the disease (within 2 year after the initiation of the treatment)]
Quality of life related to health measured by EORTC-QLQC30
Time Frame: from the inclusion to patient death, up to 1 year
Quality of life related to health measured by EORTC-QLQC30
from the inclusion to patient death, up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besançon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2017

Primary Completion (Estimated)

August 29, 2026

Study Completion (Estimated)

November 29, 2026

Study Registration Dates

First Submitted

April 13, 2017

First Submitted That Met QC Criteria

April 13, 2017

First Posted (Actual)

April 18, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 23, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • API/2016/67

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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