Immune Response Evaluation to Curative Conventional Therapy

• Conditions: Head and Neck Squamous Cell Carcinoma

• Registration Number: NCT03053661
• Lead Sponsor: University of Ulm

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2017-02-12
• Study First Submitted QC: 2017-02-12
• Study First Posted: 2017-02-15
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-11
• Primary Completion: 2020-08
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
prevalence of spontaneous tumor-specific immunity at baseline	baseline

Secondary Outcome Measures

Name	Time	Method
progression free survival at 3 years	baseline - 3 years
overall survival at 3 years	baseline - 3 years