Back to resultsModulation of Anti-tumor T Cell Responses in Cancer Patients Treated by Concomitant Radiochemotherapy (i-RTCT)
Primary Purpose
Lung Cancer, Head and Neck Cancer
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biological samples
Sponsored by
About this trial
This is an interventional basic science trial for Lung Cancer focused on measuring immunomonitoring, immune checkpoint, chemoradiation, T cells
Eligibility Criteria
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.
Sites / Locations
- CHU de BesançonRecruiting
- Centre Georges François LECLERCRecruiting
- Hôpital Nord Franche-ComtéRecruiting
- Institut Jean GodinotRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Biological samples
Arm Description
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.
Outcomes
Primary Outcome Measures
tumor antigen specific T-cell responses
tumor antigen specific T-cell responses
Secondary Outcome Measures
monitoring of immune checkpoints, immune cell death, immune suppressive cells and T-cell polarisation
monitoring of immune checkpoints, immune cell death, immune suppressive cells and T-cell polarisation
Progression free survival
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
overall survival
time between the date of initiation of treatment and the date of death from any cause
Quality of life related to health measured by EORTC-QLQC30
Quality of life related to health measured by EORTC-QLQC30
Full Information
NCT ID
NCT03117946
First Posted
April 13, 2017
Last Updated
July 30, 2021
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT03117946
Brief Title
Modulation of Anti-tumor T Cell Responses in Cancer Patients Treated by Concomitant Radiochemotherapy
Acronym
i-RTCT
Official Title
Modulation of Anti-tumor T Cell Responses in Cancer Patients Treated by Concomitant Radiochemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 29, 2017 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Head and Neck Cancer
Keywords
immunomonitoring, immune checkpoint, chemoradiation, T cells
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biological samples
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Biological samples
Intervention Description
blood and tumor tissue sample
Primary Outcome Measure Information:
Title
tumor antigen specific T-cell responses
Description
tumor antigen specific T-cell responses
Time Frame
up to 12 months after the end of radiochemotherapy
Secondary Outcome Measure Information:
Title
monitoring of immune checkpoints, immune cell death, immune suppressive cells and T-cell polarisation
Description
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
Title
Progression free survival
Description
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
Time Frame
date of first progression of the disease (within 2 year after the initiation of the treatment)]
Title
overall survival
Description
time between the date of initiation of treatment and the date of death from any cause
Time Frame
date of death from any cause (within 2 years after the initiation of the treatment)
Title
Quality of life related to health measured by EORTC-QLQC30
Description
Quality of life related to health measured by EORTC-QLQC30
Time Frame
from the inclusion to patient death, up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier ADOTEVI, Pr
Phone
+33370632212
Email
olivier.adotevi@univ-fcomte.fr
Facility Information:
Facility Name
CHU de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Depierre
Phone
0381218745
Email
sdepierre@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Bernardino DE BARI, PH
Facility Name
Centre Georges François LECLERC
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Etienne MARTIN, Dr
First Name & Middle Initial & Last Name & Degree
Etienne MARTIN, Dr
Facility Name
Hôpital Nord Franche-Comté
City
Montbéliard
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SUN, Dr
First Name & Middle Initial & Last Name & Degree
SUN, Dr
Facility Name
Institut Jean Godinot
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphanie SERVAGI VERNAT, Dr
First Name & Middle Initial & Last Name & Degree
Stéphanie SERVAGI VERNAT
12. IPD Sharing Statement
Learn more about this trial
Modulation of Anti-tumor T Cell Responses in Cancer Patients Treated by Concomitant Radiochemotherapy
We'll reach out to this number within 24 hrs