head and neck cancer
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Newly diagnosed stage III-IV HNSCC of the oral cavity, oropharynx, hypopharynx or larynx. 2) Treatment with definitive (chemo)radiation (70 Gy with or without weekly cisplatin) with photons or protons 3) Age of 18 years and older 4) Elective or therapeutic bilateral neck irradiation indicated 5) Written informed consent according to local guidelines
Exclusion criteria
Exclusion criteria: 1) Unilateral radiation therapy of the neck. 2) (Diagnostic) resection of the primary tumour. 3) Chemoradiation with carboplatin and 5-FU or radiation with cetuximab. 4) Has a history of an autoimmune disease or other systemic intercurrent disease that might affect the immunocompetence of the patient, or current or prior use (4 weeks before start of the trial) of high dose immunosuppressive therapy. 5) Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. 6) Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior enrolment in this trial. Note: participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent. 7) Has received a live vaccine within 30 days prior to enrolment in this trial. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed. In addition, Covid vaccines are allowed. 8) Has an active infection requiring systemic therapy. 9) Has a history or current evidence of any condition, therapy or laboratory abnormality that might confound the results of this trial, interfere with the subject*s participation for the full duration of this trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 10) Current pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoint is antigen-specific immunity. Antigen-specific immunity will be assessed in peripheral blood during and after (chemo)radiation, by monitoring T-cell responses to viral peptides, such as SARS-CoV-2, CEF (CMV, EBV and Influenza) and E6 and E7 antigens of HPV16. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Composition and function of circulating immune cells during and shortly after (chemo)radiation, including e.g. T- and B-lymphocytes and different myeloid cells. 2) Infiltration of immune cells within the primary tumor tissue during (chemo)radiation, including e.g. PD-1 positive T cells (optional part of the study). | — |
Countries
Netherlands
Outcome results
None listed