Immune sparing Radiotherapy strategies In head and neck Squamous cell carcinoma (IRIS)

Immune sparing Radiotherapy strategies In head and neck Squamous cell carcinoma (IRIS) - IRIS study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56801

Enrollment

Registered

2024-06-03

Start date

2024-10-01

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

head and neck cancer (HNC) head and neck squamous cell carcinoma (HNSCC)

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with mucosal squamous cell carcinoma of the head and neck amenable for radiotherapy

Exclusion criteria

Exclusion criteria: • Previously treated by irradiation in the head and neck region • Chronic inflammatory disease or immune disorders • Other malignant disease (unless in situ carcinoma or BCC) within the last 2 years.

Design outcomes

Primary

Measure	Time frame
* Numbers of immune cell populations and frequency of T cell subsets according to markers of maturation, activation, co-signaling and chemo-attractant receptors at baseline, related to patient- and tumor characteristics (tumor localization, TNM status, tumor subtype, comorbidities etc.). * Temporal changes of immune markers obtained in blood during/after treatment at 6 timepoints (baseline, 2 weeks during RT, end of RT, 2 weeks after RT, 6 weeks after RT and 3 months after RT).	—

Measure

Time frame

* Numbers of immune cell populations and frequency of T cell subsets according to markers of maturation, activation, co-signaling and chemo-attractant receptors at baseline, related to patient- and tumor characteristics (tumor localization, TNM status, tumor subtype, comorbidities etc.). * Temporal changes of immune markers obtained in blood during/after treatment at 6 timepoints (baseline, 2 weeks during RT, end of RT, 2 weeks after RT, 6 weeks after RT and 3 months after RT).

—

Secondary

Measure	Time frame
n.a.	—

Countries

Netherlands

Outcome results