Immune Response Evaluation to Curative Conventional Therapy (IRECT-01)

University of Ulm

Status: Unknown

Conditions: Head and Neck Squamous Cell Carcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT03053661

IRECT-01

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

22 participants in 2 patient groups

primary surgery + adj. C)RT

Description:

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

primary chemoradiation

Description:

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