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NCT Number: NCT03117946

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

The aim of this study is to evaluate modulation of anti-tumor T cell responses in cancer patients treated by concomitant radiochemotherapy (i-RTCT)

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Key information

Conditions

Lung Cancer Head and Neck Cancer Head and Neck Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Besançon, Besançon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biological Samples

Other

blood and tumor tissue sample

Primary outcomes

  1. tumor antigen specific T-cell responses

    Time frame: up to 12 months after the end of radiochemotherapy

    tumor antigen specific T-cell responses

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: i-RTCT

Important dates

Study start
2017
Primary completion
2023
Study completion
2025
First posted
Apr 18, 2017
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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