Ireland
--:--IST
Active, not recruiting Phase 3

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

NCT02215265 · tracked via the Priya Life Science France tracker
Sponsor
Lisette Nixon
Phase
Phase 3
Started
2015-10
Last updated
2025-02-19

Condition(s) studied

Human Papillomavirus (HPV)-Positive Oropharyngeal Cancer

Investigational drug(s) / intervention(s)

Cisplatin →Postoperative radiotherapy

Cisplatin: Chemotherapy

Postoperative radiotherapy: Postoperative radiotherapy (PORT)

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • MDADI/Overall survival co-primary endpoint — At 12 months following treatment measured using the MD Anderson Dysphagia Inventory (MDADI) score.

Trial sites (57)

FacilityCityRegionStatus
Board of Trustees of the Leland Stanford Junior University Redwood City California
Advent Health Orlando Florida
MD Anderson Cancer Centre Houston Texas
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
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
Velindre NHS Trust Cardiff United Kingdom
Castle Hill Hospital Cottingham United Kingdom
Derby Teaching Hospitals NHS Foundation Trust Derby United Kingdom
Western General Hospital Edinburgh United Kingdom
Royal Devon University Health Care NHS Foundation Trust Exeter United Kingdom
Royal Surrey County Hospital Guildford United Kingdom
St James University Hospital Leeds United Kingdom
Liverpool Head and Neck Centre Liverpool United Kingdom
University of Liverpool Liverpool United Kingdom
Cwm Taf Bro Morganwg Llantrisant United Kingdom
University College London Hospitals NHS Foundation Trust London United Kingdom
Guys and St Thomas's NHS Foundation Trust London United Kingdom
St Georges University Hospital London United Kingdom
Imperial College Healthcare NHS Trust London United Kingdom
Central Manchester University Hospital NHS Foundation Trust Manchester United Kingdom

+ 17 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02215265 on ClinicalTrials.gov ↗ ← All trials in France