Modulation of Anti-tumor T Cell Responses in Cancer Patients Treated by Concomitant Radiochemotherapy
i-RTCT
1 other identifier
interventional
220
1 country
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable lung-cancer
Started May 2017
Longer than P75 for not_applicable lung-cancer
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2017
CompletedFirst Posted
Study publicly available on registry
April 18, 2017
CompletedStudy Start
First participant enrolled
May 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 29, 2026
December 27, 2024
December 1, 2024
9.3 years
April 13, 2017
December 23, 2024
Conditions
Keywords
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
EXPERIMENTALBlood 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.
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
CHU de Besançon
Besançon, 25000, France
Centre Georges François LECLERC
Dijon, 21000, France
Hôpital Nord Franche-Comté
Montbéliard, France
Institut Jean Godinot
Reims, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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 (Estimated)
August 29, 2026
Study Completion (Estimated)
November 29, 2026
Last Updated
December 27, 2024
Record last verified: 2024-12