Spotlight on: The PATHOS Study5 August 2020
PATHOS is a Phase III trial of risk-stratified, reduced intensity adjuvant treatment in patients undergoing transoral surgery for human papillomavirus (HPV)-positive oropharyngeal cancer.
The aim of the study is to tailor treatment for participants with HPV-positive oropharyngeal cancer to reduce side-effects, particularly swallowing problems, which have a major impact on quality of life.
We are interested to see if long term toxicity, can be reduced in patients receiving either lower dose radiotherapy (Group B) or no chemotherapy (Group C), whilst proving that cure rates can be maintained.
The PATHOS study team are working closely with local centres to ensure that the latest guidelines for surgery and radiotherapy / chemotherapy treatment in a COVID environment are applied as practically as possible for all participants on trial. Please feel free to contact your local PATHOS team if you have any questions that you would like to direct to the PATHOS study team.
Our recruitment target is 1,100 patients and we currently have over 400 participants enrolled. Together with your support, we are confident that we will meet this target.
We have 34 sites in the United Kingdom and international sites open in Florida and Australia. We hope to open 30 additional sites across Europe over the next few months.
Recruitment continues until October 2022 and follow-up visits will continue until 2026.
The results will be analysed and published in 2027. You will be able to access any publications and study results with the help of your study team. No confidential information will appear in any of the results or publications.
The data from the study is reviewed every 6 months by our Independent Data Monitoring Committee (IDMC) to make sure that all the patients are safe. The committee had their last meeting in April 2020 and they were very happy with the quality of the study and recommended that the study continues.
The Speech and Language Therapists are an integral part of the PATHOS study, and they are currently in the process of analysing the Videofluoroscopies (VFs).
We also collect several blood and tissue samples before treatment and at approximately 4 weeks, 6 months, 12 months, 18 months and 2 years following treatment. These blood and tissue samples will be used for future research projects, which will allow us to learn more about HPV related oropharynx cancer, as well as identifying better ways to treat the disease.
The study is looking at long term parameters, and therefore the success of the study is directly related to how many follow-up visits we manage to collect.
The key timepoints are:
- Pre-Surgery Assessments
- Baseline VFs and Water Swallow Tests
- 4 Weeks Post-Surgery
- 4 Weeks Post-Treatment Questionnaires (MDADI, QLQ C30 and H&N35)
- All 12 month follow-up assessments are important.
Further information is available at
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The Centre for Trials Research is a UKCRC-registered clinical trials unit. It is publicly-funded to enable applied research that informs policy in health and social care in Wales and the UK, and is currently running studies across Wales, the UK and internationally. The Centre is funded through Welsh government by Health and Care Research Wales, and Cancer Research UK.