Immune Response Evaluation to Curative Conventional Therapy

Head and Neck Squamous Cell Carcinoma Clinical Trial

— IRECT-01  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03053661
• Other study ID #: IRECT-01
• Status: Active, not recruiting
• Start date: August 2013
• Est. completion date: August 2020

Study information

• Verified date: October 2018
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of spontaneous tumor-specific immunity at baseline		baseline
Primary	dynamics of tumor-specific immunity and immune modulatory cells during conventional treatment		7-12 weeks (treatment phase)
Primary	dynamics of tumor-specific immunity and immune modulatory cells during follow up		12 months after end of treatment
Secondary	overall survival at 3 years		baseline - 3 years
Secondary	progression free survival at 3 years		baseline - 3 years