Evaluating immune function in head and neck cancer patients treated with proton or photon therapy
Effect of Protons Versus Photons on Immunological Function in Head and Neck Cancer: a Pilot Study
This study is testing how different types of radiation therapy affect the immune system in patients with advanced head and neck cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Drugs / interventions | cetuximab, radiation |
| Locations | 1 site (Groningen) |
| Trial ID | NCT06016699 on ClinicalTrials.gov |
What this trial studies
This pilot observational cohort study focuses on patients with newly diagnosed stage III-IV head and neck squamous cell carcinoma (HNSCC) receiving definitive (chemo)radiation therapy using either proton or photon techniques. Patients will be assigned to one of the treatment modalities based on established guidelines. The study aims to assess immunological function by collecting peripheral blood mononuclear cells (PBMCs) at various time points throughout and after treatment, comparing these samples to baseline measurements. The evaluation will utilize IFN-γ-ELISPOT to determine the presence of antigen-specific T-cells.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed stage III-IV HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx who are eligible for definitive (chemo)radiation.
Not a fit: Patients who have undergone unilateral radiotherapy, have a history of autoimmune diseases, or are currently on high-dose immunosuppressive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how different radiation therapies impact immune function in head and neck cancer patients, potentially leading to improved treatment strategies.
How similar studies have performed: While this approach is observational and may not have been extensively tested in this specific context, similar studies evaluating immune responses to different radiation modalities have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newly diagnosed stage III-IV HNSCC of the oral cavity, oropharynx, hypopharynx or larynx. * Treatment with definitive (chemo)radiation (70 Gy with or without weekly cisplatin) with photons or protons. * Age of 18 years and older. * Elective or therapeutic bilateral neck irradiation indicated. * Written informed consent according to local guidelines. Exclusion Criteria: * Unilateral radiotherapy of the neck. * (Diagnostic) resection of the primary tumour. * Chemoradiation with carboplatin and 5-FU or radiation combined with cetuximab. * 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. * 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. * Participation 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. * Active infection requiring systemic therapy. * Current pregnancy. * 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.
Where this trial is running
Groningen
- University Medical Center Groningen (UMCG) — Groningen, Netherlands (Recruiting)
Study contacts
- Study coordinator: Tineke Meijer, MD, PhD
- Email: t.van.zon@umcg.nl
- Phone: 0015 361 6161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.