To study the immune effects of novel radiotherapy schedules by longitudinal immune profiling. There will be a specific focus on actionable immune targets and their temporal patterns that can be tested in future immune-radiotherapy combination trials…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* 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 outcome
n.a.
Background summary
Radiotherapy (RT) for advanced-stage head and neck squamous cell carcinoma
(HNSCC) results in an unfavorable 5-year overall survival of 40%, and there is
a strong biological rationale for improving outcome by combinatorial treatment
with immunotherapy. However, also immunosuppressive effects of radiotherapy
have been reported and recently a randomized phase-III trial failed to show any
survival benefit following the combination of a PD-L1 inhibitor with
chemoradiotherapy. It is hypothesized that the combination of these
individually effective treatments failed because of radiation-induced
lymphodepletion and that the key therefore lies in reforming conventional
radiotherapy, which typically consists of large lymphotoxic radiation fields of
35 fractions. With the current study, we build a biobank for future immunologic
profiling to explore Immune sparing Radiotherapy strategies In head and neck
Squamous cell carcinoma (IRIS). Based on the acquired knowledge we may be able
to reshape conventional radiotherapy for future effective immune-radiotherapy
combinations.
Study objective
To study the immune effects of novel radiotherapy schedules by longitudinal
immune profiling. There will be a specific focus on actionable immune targets
and their temporal patterns that can be tested in future immune-radiotherapy
combination trials.
Study design
Biobank study of peripheral blood samples obtained at baseline, 2 weeks during
RT, end of RT, 2 weeks after RT, 6 weeks after RT and 3 months after RT.
Study burden and risks
To study the immune effects during and after treatment, patients will be asked
for 6 blood draws in total (2x10mL EDTA each time) during regular visits to the
outpatient clinic. Blood will be collected by vena punctures, which may cause
only slight physical discomfort. There will be no extra study related physical
examinations, tests or questionnaires.
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
Patients with mucosal squamous cell carcinoma of the head and neck amenable for
radiotherapy
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85175.078.23 |