Immune Response Evaluation to Curative Conventional Therapy

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03053661

Acronym

IRECT-01

Enrollment

Registered

2017-02-15

Start date

2013-08-31

Completion date

2020-08-31

Last updated

2018-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Head and Neck Squamous Cell Carcinoma, cancer-specific immunity, cancer immunology, cancer-testis antigens, human papilloma virus, immune modulatory cells

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	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

Measure	Time frame
overall survival at 3 years	baseline - 3 years
progression free survival at 3 years	baseline - 3 years

Outcome results