HNSCCPRO-IMMUNONCT06016699
Immunological Function After Radiation With Either Proton or Photon Therapy
An observational study of HNSCC and Head and Neck Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HNSCC, Head and Neck Cancer, Oropharynx Cancer
- What is being tested?
- blood draws
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Sep 2021to 1 Apr 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen (UMCG)
Groningen, 9700 RB
Anneke Eerkens, MSc, 0015 361 6161, a.l.eerkens@umcg.nl
About this study
Official title: Effect of Protons Versus Photons on Immunological Function in Head and Neck Cancer: a Pilot Study
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.
- Being tested
- blood draws
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms, Oropharyngeal Neoplasms, Hypopharyngeal Neoplasms, Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Chemoradiation with protons | HNSCC patients treated with standard-of-care chemoradiation with protons. Receives: Other: blood draws | |
| Chemoradiation with photons | HNSCC patients treated with standard-of-care chemoradiation with photons. Receives: Other: blood draws | |
| Radiation with protons | HNSCC patients treated with standard-of-care radiation with protons. Receives: Other: blood draws | |
| Radiation with photons | HNSCC patients treated with standard-of-care radiation with photons. Receives: Other: blood draws |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Differences in composition and function of circulating immune cells will be determined by flow cytometry-based assays using marker for e.g. T- and B-lymphocytes and different myeloid cells such as derived suppressor cells.
Measured: 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).
Immunohistological staining will be performed on these tumour tissues to assess changes in the composition of immune cells after (chemo)radiation with protons versus photons These assays include molecular analyses and immunohistochemical staining to characterize the type of the intratumoral immune cell infiltrate. In particular, immunohistochemical staining to identify immune cell populations and T cell subpopulations within the tumour tissue can be applied, including, but not limited to, CD4, CD8, FoxP3, CD20, CD163, CD68, PDL1 and PD1. Both changes in absolute numbers and ratios of different immune cell types will be assessed.
Measured: At baseline (week 0) and during (chemo)radiation (week 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start23 Sep 2021
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HNSCCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016699
- Sponsor's protocol ID
- NL75013.042.20
- Acronym
- PRO-IMMUNO
- Status last verified
- Aug 2023
- First submitted
- 23 Aug 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Protons Versus Photons on Immunological Function in Head and Neck Cancer: a Pilot Study
- ClinicalTrials.gov ID
- NCT06016699
- Acronym / sponsor ID
- PRO-IMMUNO / NL75013.042.20
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chemoradiation with protons | – | Other: blood drawsHNSCC patients treated with standard-of-care chemoradiation with protons. |
| Chemoradiation with photons | – | Other: blood drawsHNSCC patients treated with standard-of-care chemoradiation with photons. |
| Radiation with protons | – | Other: blood drawsHNSCC patients treated with standard-of-care radiation with protons. |
| Radiation with photons | – | Other: blood drawsHNSCC patients treated with standard-of-care radiation with photons. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood drawsBlood 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 | Other | Chemoradiation with photons, Chemoradiation with protons, Radiation with photons, Radiation with protons |
Primary outcome
The difference in antigen-specific immunity in HNSCC patients undergoing (chemo)radiation with protons versus photons.
Time frame: 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)
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).
2 secondary outcomes
Differences in composition and function of circulating immune cells during and after (chemo)radiation with protons versus photons.
Time frame: 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).
Time frame: At baseline (week 0) and during (chemo)radiation (week 3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HNSCC and Head and Neck Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tineke Meijer, MD, PhD (0015 361 6161, t.van.zon@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in antigen-specific immunity in HNSCC patients undergoing (chemo)radiation with protons versus photons. (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.