Immune Response Evaluation to Curative Conventional Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Immune Response Evaluation to Curative Conventional Therapy of Stage III/IV Head and Neck Squamous Cell Carcinoma Patients

Conditions
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Head and Neck Squamous Cell Carcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| primary surgery + adj. C)RT<br>treatment naive patients to be treated by conventional primary surgery followed by adjuvant (chemo-)radiotherapy with curative intent | |
| primary chemoradiation<br>treatment naive patients to be treated by conventional primary chemoradiotherapy with curative intent | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of spontaneous tumor-specific immunity at baseline |  | baseline | 
| dynamics of tumor-specific immunity and immune modulatory cells during conventional treatment |  | 7-12 weeks (treatment phase) | 
| dynamics of tumor-specific immunity and immune modulatory cells during follow up |  | 12 months after end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival at 3 years |  | baseline - 3 years | 
| progression free survival at 3 years |  | baseline - 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and Neck Squamous Cell Carcinoma, cancer-specific immunity, cancer immunology, cancer-testis antigens, human papilloma virus, immune modulatory cells