To monitor the systemic effects of radiotherapy (RT) alone or in combination with concurrent chemotherapy (CRT) (Cisplatin) on the immune response and T-cells over time in patients with HPV+ head and neck squamous cell carcinoma (HNSCC).
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Hoofd-hals plaveiselcelcarcinomen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To monitor the systemic effects of radiotherapy (RT) alone or in combination
with concurrent chemotherapy (CRT) (Cisplatin) on the immune response and
T-cells over time in patients with head and neck squamous cell carcinoma
(HNSCC). T-cell fenotypic changes and T-cell related functional changes will be
investigated.
Secondary outcome
- To compare the systemic immunological effect of RT alone to CRT in HNSCC
patients.
- To determine the optimal timing for future vaccination in HNSCC patients
Background summary
(Chemo)Radiotherapy is an important treatment for head and neck squamous cell
cancer (HNSCC) which can be used in a curative setting.
Although radiotherapy is known to negatively affect lymphoid cells,
accumulating evidence indicates that radiotherapy may also modify the tumour
environment and stimulate an antitumoural immune response. These
immunomodulatory properties could predict collaboration between cancer
immunotherapy and radiotherapy in future. However, the effect of radiotherapy
on the general immune responses is currently not well evaluated.
Therefore the aim of this exploratory study is to investigate the T-cell
responses before, during and after (chemo)radiotherapy.
Study objective
To monitor the systemic effects of radiotherapy (RT) alone or in combination
with concurrent chemotherapy (CRT) (Cisplatin) on the immune response and
T-cells over time in patients with HPV+ head and neck squamous cell carcinoma
(HNSCC).
Study design
Single centre, open-label, observational, explorative study.
Study burden and risks
All participating patients will be treated with standard radiotherapy, exactly
the same as when they would not participate. Only some additional blood
sampling will take place for study purposes. Blood sampling will take place
during regular hospital visits and, if possible, during regular blood sampling.
We therefor consider the physical discomfort associated with participation in
this study as mild.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
- Patients should be at least 18 years of age
- Patients should be able and willing to provide informed consent
- Patients should have the clinical diagnosis of HNSCC
- Tumour should be HPV positive
- WHO performance status 0-2
- Patients are scheduled for:
1.Primary external beam radiotherapy (EBRT)
2.Primary EBRT with concurrent chemotherapy (Cisplatin);
Exclusion criteria
- Any medical condition that may interfere with the study objectives
- Positive test result for HIV or Hepatitis B or C
- Any other active malignancy than cervical cancer.
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 | NL46158.031.14 |