Status:
UNKNOWN
Immunological Function After Radiation With Either Proton or Photon Therapy
Lead Sponsor:
University Medical Center Groningen
Conditions:
HNSCC
Head and Neck Cancer
Eligibility:
All Genders
18+ years
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. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 23 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06016699
Start Date
September 23 2021
End Date
April 1 2024
Last Update
August 30 2023
Active Locations (1)
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1
University Medical Center Groningen (UMCG)
Groningen, Netherlands, 9700 RB