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

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Recruiting
CT.gov ID
NCT03117946
Collaborator
(none)
220
4
1
66.1
55
0.8

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Other: Biological samples
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
220 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Modulation of Anti-tumor T Cell Responses in Cancer Patients Treated by Concomitant Radiochemotherapy
Actual Study Start Date :
May 29, 2017
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. tumor antigen specific T-cell responses [up to 12 months after the end of radiochemotherapy]

    tumor antigen specific T-cell responses

Secondary Outcome Measures

  1. 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

  2. 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

  3. 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

  4. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Besançon Besançon France 25000
2 Centre Georges François LECLERC Dijon France 21000
3 Hôpital Nord Franche-Comté Montbéliard France
4 Institut Jean Godinot Reims France

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Besancon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT03117946
Other Study ID Numbers:
  • API/2016/67
First Posted:
Apr 18, 2017
Last Update Posted:
Aug 2, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Besancon
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2021