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

NCT02215265 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1269

Last updated 2025-02-19

No results posted yet for this 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.

Conditions

  • Human Papillomavirus (HPV)-Positive Oropharyngeal Cancer

Interventions

DRUG

Cisplatin

Chemotherapy

RADIATION

Postoperative radiotherapy

Postoperative radiotherapy (PORT)

Sponsors & Collaborators

  • UNICANCER

    collaborator OTHER

  • AdventHealth

    collaborator OTHER

  • University of Leipzig

    collaborator OTHER

  • Princess Alexandra Hospital, Brisbane, Australia

    collaborator OTHER

  • Stanford University

    collaborator OTHER

  • Lisette Nixon

    lead OTHER_GOV

Principal Investigators

  • Mererid Evans, MBBch, PhD · Velindre NHS Trust

  • Terrence Jones, MBBS,MD · Aintree University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2027-10-31
Completion
2028-04-30

Countries

  • United States
  • Australia
  • France
  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02215265 on ClinicalTrials.gov