Immune Response Evaluation to Curative Conventional Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2020-08-31

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.

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Detailed Description

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Conditions

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Head and Neck Squamous Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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primary surgery + adj. C)RT

treatment naive patients to be treated by conventional primary surgery followed by adjuvant (chemo-)radiotherapy with curative intent

No interventions assigned to this group

primary chemoradiation

treatment naive patients to be treated by conventional primary chemoradiotherapy with curative intent

No interventions assigned to this group

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No