Head and Neck Squamous Cell CarcinomaIRECT-01NCT03053661
Immune Response Evaluation to Curative Conventional Therapy
An observational study of Head and Neck Squamous Cell Carcinoma, run by University of Ulm.
Trial summary
The IRECT trial is a non-interventional, prospective clinical trial using modern immune monitoring techniques over the course of the standard of care for HNSCC. The dynamics of host/tumor immune interactions during the conventional standard treatment will be analyzed to find the most promising target antigen and to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Aug 2020
- Phase
- Observational
- 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
Study population: stage III-IVa/b treatment-naive head and neck squamous cell carcinoma patients
Who may be able to join
- newly diagnosed patients with stage III-IVa/b head and neck squamous cell carcinoma
- fit for treatment with curative intent
- conventional primary treatment
- primary surgical treatment
- primary radiotherapeutic treatment
- informed consent
- >18 years of age
- sufficient contraception
Who cannot join
- distant metastasis at baseline
- severe concomitant disease compromising curative treatment
- previously diagnosed other malignant diseases
- active immunosuppressive therapy
- known immune defect
- pregnancy
- anemia requiring treatment at study entry (<9g/dl)
About this study
Official title: Immune Response Evaluation to Curative Conventional Therapy of Stage III/IV Head and Neck Squamous Cell Carcinoma Patients
The IRECT trial is a non-interventional, prospective clinical trial using modern immune monitoring techniques over the course of the standard of care for HNSCC. The dynamics of host/tumor immune interactions during the conventional standard treatment will be analyzed to find the most promising target antigen and to develop a strategy how and when specific immunotherapy should be added to the current treatment schedule.
The results from this trial will help to understand how state of the art treatment can be complemented using cancer-testis antigen specific vaccines and immune-modulating drugs to improve the outcome of head and neck cancer patients.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Head and Neck Squamous Cell Carcinoma, cancer-specific immunity, cancer immunology, cancer-testis antigens, human papilloma virus, immune modulatory cells
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| primary surgery + adj. C)RT | treatment naive patients to be treated by conventional primary surgery followed by adjuvant (chemo-)radiotherapy with curative intent | |
| primary chemoradiation | treatment naive patients to be treated by conventional primary chemoradiotherapy with curative intent |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of spontaneous tumor-specific immunity at baseline
Measured: baseline
dynamics of tumor-specific immunity and immune modulatory cells during conventional treatment
Measured: 7-12 weeks (treatment phase)
dynamics of tumor-specific immunity and immune modulatory cells during follow up
Measured: 12 months after end of treatment
Secondary outcomes (2)
overall survival at 3 years
Measured: baseline - 3 years
progression free survival at 3 years
Measured: baseline - 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study startAug 2013
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Laban, MD, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053661
- Sponsor's protocol ID
- IRECT-01
- Acronym
- IRECT-01
- Status last verified
- Oct 2018
- First submitted
- 12 Feb 2017
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
von Witzleben A, Fehn A, Grages A, Ezic J, Jeske SS, Puntigam LK, Brunner C, Kraus JM, Kestler HA, Doescher J, Brand M, Theodoraki MN, Ottensmeier CH, Hoffmann TK, Schuler PJ, Laban S. Prospective longitudinal study of immune checkpoint molecule (ICM) expression in immune cell subsets during curative conventional therapy of head and neck squamous cell carcinoma (HNSCC). Int J Cancer. 2021 Apr 15;148(8):2023-2035. doi: 10.1002/ijc.33446. Epub 2020 Dec 30.
PubMed 33336372
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response Evaluation to Curative Conventional Therapy of Stage III/IV Head and Neck Squamous Cell Carcinoma Patients
- ClinicalTrials.gov ID
- NCT03053661
- Acronym / sponsor ID
- IRECT-01 / IRECT-01
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Head and Neck Squamous Cell Carcinoma, cancer-specific immunity, cancer immunology, cancer-testis antigens, human papilloma virus, immune modulatory cells
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 15 Feb 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 IRECT trial is a non-interventional, prospective clinical trial using modern immune monitoring techniques over the course of the standard of care for HNSCC. The dynamics of host/tumor immune interactions during the conventional standard treatment will be analyzed to find the most promising target antigen and to develop a strategy how and when specific immunotherapy should be added to the current treatment schedule.
The results from this trial will help to understand how state of the art treatment can be complemented using cancer-testis antigen specific vaccines and immune-modulating drugs to improve the outcome of head and neck cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| primary surgery + adj. C)RT | – | –treatment naive patients to be treated by conventional primary surgery followed by adjuvant (chemo-)radiotherapy with curative intent |
| primary chemoradiation | – | –treatment naive patients to be treated by conventional primary chemoradiotherapy with curative intent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- stage III-IVa/b treatment-naive head and neck squamous cell carcinoma patients
Key inclusion criteria (8 listed)
- newly diagnosed patients with stage III-IVa/b head and neck squamous cell carcinoma
- fit for treatment with curative intent
- conventional primary treatment
- primary surgical treatment
- primary radiotherapeutic treatment
Key exclusion criteria (7 listed)
- distant metastasis at baseline
- severe concomitant disease compromising curative treatment
- previously diagnosed other malignant diseases
- active immunosuppressive therapy
- known immune defect
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of spontaneous tumor-specific immunity at baseline
Time frame: baseline
dynamics of tumor-specific immunity and immune modulatory cells during conventional treatment
Time frame: 7-12 weeks (treatment phase)
dynamics of tumor-specific immunity and immune modulatory cells during follow up
Time frame: 12 months after end of treatment
2 secondary outcomes
overall survival at 3 years
Time frame: baseline - 3 years
progression free survival at 3 years
Time frame: baseline - 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Derived from this study: PubMed 33336372von Witzleben A, Fehn A, Grages A, Ezic J, Jeske SS, Puntigam LK, Brunner C, Kraus JM, Kestler HA, Doescher J, Brand M, Theodoraki MN, Ottensmeier CH, Hoffmann TK, Schuler PJ, Laban S. Prospective longitudinal study of immune checkpoint molecule (ICM) expression in immune cell subsets during curative conventional therapy of head and neck squamous cell carcinoma (HNSCC). Int J Cancer. 2021 Apr 15;148(8):2023-2035. doi: 10.1002/ijc.33446. Epub 2020 Dec 30.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Squamous Cell Carcinoma, run by University of Ulm.
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 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
prevalence of spontaneous tumor-specific immunity at baseline (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03053661, which also lists 1 linked publication.
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 11 Oct 2018.