Immunological Function After Radiation With Either Proton or Photon Therapy

NCT06016699 | Unknown

• 1 other identifier: NL75013.042.20
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot prospective observational cohort study, comprising patients with head and neck cancer (HNSCC) treated with standard of care definitive (chemo)radiation either with photons or protons. Patients will be assigned for protons or photons based on the guidelines of the National Indication Protocol for Proton therapy of the Netherlands. Immunological function will be evaluated by the collection of peripheral blood mononuclear cells (PBMCs). Blood samples will be collected at baseline, during (chemo)radiation (end of week 3 and/or before week 4 of treatment) and after completion of (chemo)radiation (week 9, week 12, week 20, week 34 and week 60, respectively 1 week, 5 weeks, 3 months, 6 months and 12 months after completion of (chemo)radiation). To quantify immunological function, PBMCs collected during (chemo)radiation and after (chemo)radiation will be compared with that before (chemo)radiation (week 0), using IFN-γ-ELISPOT to screen for the presence of antigen-specific T-cell responses. Furthermore, flow cytometry panels will be used to determine global changes in immune cell proficiency. Histological evaluation will take place at baseline and week 3 to examine changes in immune infiltration within tumour tissue during proton versus photon (chemo)radiation. This biopsy part of the study is optional for the patient. Archival tissue from the biopsy that was taken at diagnosis will be used for the baseline assessments. Biopsy at week 3 week will be taken for all patients who agree to participate in this optional part of the study.

Conditions

HNSCC; Head and Neck Cancer; Oropharynx Cancer; Hypopharynx Cancer; Larynx Cancer

Outcome Measures

Primary Outcomes (1)

• The difference in antigen-specific immunity in HNSCC patients undergoing (chemo)radiation with protons versus photons.

  Antigen-specific immunity will be assessed by monitoring antigen-specific T-cell responses in peripheral blood before, during and after (chemo)radiation (up to 12 months after completion of (chemo)radiation) to viral peptides such as SARS-CoV-2 peptides and CEF peptides (CMV, EBV and Influenza).

  At baseline (week 0), during (chemo)radiation (week 3) and after (chemo)radiation (week 9, week 12, week 20, week 34 and week 60, respectively week, 5 weeks, 3 months, 6 months and 12 months after completion of (chemo)radiation)

Secondary Outcomes (2)

• Differences in composition and function of circulating immune cells during and after (chemo)radiation with protons versus photons.

  At baseline (week 0), during (chemo)radiation (week 3) and after (chemo)radiation (week 9, week 12, week 20, week 34 and week 60, respectively week, 5 weeks, 3 months, 6 months and 12 months after completion of (chemo)radiation)

• Immune infiltrate composition within the primary tumour tissue before and during (chemo)radiation with photons versus protons (optional part of the study).

  At baseline (week 0) and during (chemo)radiation (week 3)

Study Arms (4)

Chemoradiation with protons

HNSCC patients treated with standard-of-care chemoradiation with protons.

Other: blood draws

Chemoradiation with photons

HNSCC patients treated with standard-of-care chemoradiation with photons.

Other: blood draws

Radiation with protons

HNSCC patients treated with standard-of-care radiation with protons.

Other: blood draws

Radiation with photons

HNSCC patients treated with standard-of-care radiation with photons.

Other: blood draws

Interventions

blood draws OTHER

Blood draws to collect PBMCs at baseline (week 0), during (chemo)radiation treatment (end of week 3 and/or before delivery of cycle 4 of cisplatin) and after conclusion of (chemo)radiation (week 9, week 12, week 20, week 34 and week 60, respectively 1 week, 5 weeks, 3 months, 6 months and 12 months after completion of (chemo)radiation) in order to compare immunological function upon treatment with either protons or photons

Chemoradiation with photons; Chemoradiation with protons; Radiation with photons; Radiation with protons

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be recruited at the Univeristy Medical Center Groningen (UMCG( and consists of adult patients recently diagnosed with stage III-IV HNSCC. Both photon and proton radiation are standard-of-care treatments for patients with HNSCC.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen (UMCG)

Groningen, 9700 RB, Netherlands

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms; Oropharyngeal Neoplasms; Hypopharyngeal Neoplasms; Laryngeal Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Tineke Meijer, MD, PhD

CONTACT

0015 361 6161; t.van.zon@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 30, 2023
• Study Start: September 23, 2021
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

NL (1)