Post-operative Adjuvant Treatment for HPV-positive Tumours (PATHOS)

Running, not enrolling · Phase 3

Conditions studied: Human Papillomavirus (HPV)-Positive Oropharyngeal Cancer

In brief

The main objectives of the PATHOS study are: To assess whether swallowing function can be improved following transoral resection of HPV-positive OPSCC, by reducing the intensity of adjuvant treatment protocols. The aim is to personalise treatment, based on disease biology (HPV status and pathology findings), to optimise patient outcomes. To demonstrate the non-inferiority of reducing the intensity of adjuvant treatment protocols in terms of overall survival in the reduced intensity treatment arms.

Key facts

Study ID

NCT02215265

Run by

Lisette Nixon

People needed

1269

Starts

2015-10-01

Expected to finish

2028-04-01

Last updated by the study team

2025-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed or suspected squamous cell carcinoma of the oropharynx.
• UICC/AJCC TNM 7th edition stage T1-T3, N0-N2b (or UICC TNM 8th edition stage T1-T3, N0-N1) disease.
• Multidisciplinary team (MDT) decision to treat with primary transoral resection and neck dissection.
• Patients considered fit for surgery and adjuvant radiotherapy
• Aged 18 or over.
• Written informed consent provided.

You may not qualify if…

• Known HPV negative squamous cell carcinomas of the head and neck: A negative result for p16 Immunohistochemistry automatically excludes a patient from the trial. If initial p16 testing is positive but High Risk HPV (HR HPV) In-Situ Hybridization (ISH)/Polymerase Chain Reaction (PCR) does not demonstrate the presence of HR HPV DNA, the patient will also be excluded. Patients who are p16+ may complete swallowing assessments, excluding videofluoroscopy, and surgery whilst HR HPV DNA status is being determined (with recourse to central concordance testing, if appropriate, for UK centres). HPV positivity, as determined by p16 and the demonstration of HR HPV DNA is essential before patients undergo videofluoroscopy or randomisation.
• T4 and/or T1-T3 tumours where transoral surgery is considered not feasible.
• UICC/AJCC TNM 7th edition N2c-N3 nodal disease (or UICC/AJCC TNM 8th edition N2-N3 nodal disease).
• Patients for whom transoral surgery and neck dissection is not considered the primary treatment modality.
• Current smokers with clinically staged N2b disease (including smokers up to 6 months before diagnosis), even if HPV-positive. Vaping is permitted and should be considered as non-smoking status.
• Any pre-existing medical condition likely to impair swallowing function and/ or a history of pre-existing swallowing dysfunction prior to index oropharyngeal cancer.
• Patients with distant metastatic disease as determined by routine pre-operative staging radiological investigations e.g., CT thorax and upper abdomen or PET-CT.
• Patients with a history of malignancy in the last 5 years, except basal cell carcinoma of the skin or carcinoma in-situ of the cervix.
• Women who are pregnant or breastfeeding and fertile women who will not be using contraception during the trial.

Where it is running

• Advent Health — Orlando, Florida, United States
• MD Anderson Cancer Centre — Houston, Texas, United States
• Metro South Health — Brisbane, Australia
• Unicancer — Paris, France
• Vivantes Klinikum — Berlin, Germany
• Zentrum für Hals-, Nasen- und Ohrenheilkunde — Giessen, Germany
• Asklepios Kliniken — Hamburg, Germany
• Kath Marienkrankenhaus gGmbH — Hamburg, Germany
• Universitaetsklinikum des Saarlandes — Homburg, Germany
• Universitat Leipzig — Leipzig, Germany
• Ernst von Bergmann Klinikum — Potsdam, Germany
• Städtisches Klinikum Solingen — Solingen, Germany
• Universitätsklinikum Ulm — Ulm, Germany
• University Hospitals Dorset NHS Foundation — Poole, Dorset, United Kingdom
• Royal United Hospitals Bath NHS Foundation Trust — Bath, United Kingdom
• Queen Elizabeth Hospital — Birmingham, United Kingdom
• Royal Blackburn Hospital — Blackburn, United Kingdom
• Royal Sussex County Hospital — Brighton, United Kingdom
• University Hospitals Bristol NHS Foundation Trust — Bristol, United Kingdom
• Cambridge University Hospitals NHS Foundation Trust — Cambridge, United Kingdom
• Kent and Canterbury Hospital — Canterbury, United Kingdom
• HPV Research Group Section of Pathology Cardiff University ,School of Medicine — Cardiff, United Kingdom
• Cardiff and Vale University Local Health Board — Cardiff, United Kingdom
• Centre for Trials Research — Cardiff, United Kingdom
• Board of Trustees of the Leland Stanford Junior University — Redwood City, California, United States

Full record on ClinicalTrials.gov

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