Lung Canceri-RTCTNCT03117946
Modulation of Anti-tumor T Cell Responses in Cancer Patients Treated by Concomitant Radiochemotherapy
A study testing Biological samples in people with Lung Cancer and Head and Neck Cancer, run by Centre Hospitalier Universitaire de Besancon at 4 sites in France.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Head and Neck Cancer
- What is being tested?
- Biological samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 4 sitesFrance
- Study dates
- 29 May 2017to 9 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU de Besançon
Besançon, France, 25000
Centre Georges François LECLERC
Dijon, 21000
Hôpital Nord Franche-Comté
Montbéliard
Institut Jean Godinot
Reims
About this study
The aim of this study is to evaluate modulation of anti-tumor T cell responses in cancer patients treated by concomitant radiochemotherapy (i-RTCT)
- Conditions
- Lung Cancer, Head and Neck Cancer
- Being tested
- Biological samples
- Keywords
- immunomonitoring, immune checkpoint, chemoradiation, T cells
- Medical subject headings
- Lung Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samplesOther
blood and tumor tissue sample
| Study group | Role | What they receive |
|---|---|---|
| Biological samples | Experimental | 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. Receives: Other: Biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor antigen specific T-cell responses
tumor antigen specific T-cell responses
Measured: 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
monitoring of immune checkpoints, immune cell death, immune suppressive cells and T-cell polarisation
Measured: up to 12 months after the end of radiochemotherapy
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
Measured: date of first progression of the disease (within 2 year after the initiation of the treatment)]
overall survival
time between the date of initiation of treatment and the date of death from any cause
Measured: 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
Quality of life related to health measured by EORTC-QLQC30
Measured: from the inclusion to patient death, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start29 May 2017
- Primary completion17 Aug 2023
- Study completion9 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117946
- Sponsor's protocol ID
- API/2016/67
- Acronym
- i-RTCT
- Status last verified
- Jul 2026
- First submitted
- 13 Apr 2017
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Anti-tumor T Cell Responses in Cancer Patients Treated by Concomitant Radiochemotherapy
- ClinicalTrials.gov ID
- NCT03117946
- Acronym / sponsor ID
- i-RTCT / API/2016/67
- Conditions
- Lung Cancer, Head and Neck Cancer
- Keywords
- immunomonitoring, immune checkpoint, chemoradiation, T cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 29 May 2017 (actual)
- Primary completion
- 17 Aug 2023 (actual)
- Study completion
- 9 Jan 2025 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biological samples | Experimental | Other: Biological samplesBlood 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological samplesblood and tumor tissue sample | Other | Biological samples |
Primary outcome
tumor antigen specific T-cell responses
Time frame: up to 12 months after the end of radiochemotherapy
tumor antigen specific T-cell responses
4 secondary outcomes
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
Progression free survival
Time frame: date of first progression of the disease (within 2 year after the initiation of the treatment)]
overall survival
Time frame: 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
Time frame: from the inclusion to patient death, up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological samples in people with Lung Cancer and Head and Neck Cancer, run by Centre Hospitalier Universitaire de Besancon at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor antigen specific T-cell responses (time frame: up to 12 months after the end of radiochemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.