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ACTIVE NOT RECRUITING
NCT02215265
PHASE3

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

Sponsor: Lisette Nixon

View on ClinicalTrials.gov

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.

Official title: A Phase III Trial of Risk-stratified, Reduced Intensity Adjuvant Treatment in Patients Undergoing Transoral Surgery for Human Papillomavirus (HPV)-Positive Oropharyngeal Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1269

Start Date

2015-10

Completion Date

2028-04

Last Updated

2025-02-19

Healthy Volunteers

No

Interventions

DRUG

Cisplatin

Chemotherapy

RADIATION

Postoperative radiotherapy

Postoperative radiotherapy (PORT)

Locations (57)

Board of Trustees of the Leland Stanford Junior University

Redwood City, California, United States

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

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

The Christie NHS Foundation Trust

Manchester, United Kingdom

The Pennine Acute Hospital Trust

Manchester, United Kingdom

The James Cook University Hospital

Middlesbrough, United Kingdom

Royal Victoria Infirmary

Newcastle upon Tyne, United Kingdom

Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, United Kingdom

Aneurin Bevan University Health Board

Newport, United Kingdom

Northampton General Hospital

Northampton, United Kingdom

Nottingham City Hospital

Nottingham, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

University Hospital Plymouth

Plymouth, United Kingdom

Queen Alexandra Hospital

Portsmouth, United Kingdom

Royal Preston Hospital

Preston, United Kingdom

Royal Berkshire Hospital

Reading, United Kingdom

University Hospital Southampton

Southampton, United Kingdom

Royal Stoke Hospital

Stoke, United Kingdom

City Hospitals Sunderland NHS Foundation Trust

Sunderland, United Kingdom

Swansea Bay University Local Health Board

Swansea, United Kingdom