Post-operative adjuvant treatment for HPV-positive tumours (PATHOS)
Research type
Research Study
Full title
A Phase II/III trial of risk-stratified, reduced intensity adjuvant treatment in patients undergoing transoral surgery for Human papillomavirus (HPV)-positive oropharyngeal cancer
IRAS ID
159836
Contact name
Sarah Townsend
Contact email
Sponsor organisation
Velindre Cancer Centre
Eudract number
2014-003392-32
Clinicaltrials.gov Identifier
2014/VCC/0014, Sponsor Number; CRUK/13/025, Funder Number
Duration of Study in the UK
4 years, 1 months, 20 days
Research summary
Oropharyngeal cancer caused by Human Papillomavirus (HPV) infection is increasing in incidence in the UK and other developed countries. It affects younger patients and has a better prognosis than most other head and neck cancers. Patients cured of their disease often have to live for several decades with the side-effects of their treatment which can be permanent and have a major impact on quality of life. This study will recruit approximately 242 UK patients over 3 years.
For patients enrolled into PATHOS, it will have been decided by local teams that they should undergo surgery to remove the primary tumour using a laser or robot, and a neck dissection to remove the lymph glands in the neck which may also contain cancerous cells. After surgery, the cancer that has been removed will be examined by a pathologist for features that can help predict whether further treatment in the form of radiotherapy and/or chemotherapy is recommended.
Around 10% of patients will not require any further treatment after surgery (group A). Patients for whom radiotherapy alone is recommended (group B), will be randomly allocated to receive either standard dose post-operative radiotherapy (60 Gray in 30 treatments over 6 weeks) or lower dose radiotherapy (50 Gray in 25 treatments over 5 weeks). Other patients (group C) will be allocated to receive either radiotherapy with chemotherapy (2 doses of Cisplatin) or radiotherapy alone at the same dose (60 Gray in 30 treatments over 6 weeks).
The aim is to see if long term toxicity, particularly swallowing problems, can be reduced in patients receiving either lower dose radiotherapy (group B) or no chemotherapy (group C), without affecting the chance of cure. If the study recruits well, it will continue to recruit >800 patients to prove that cure rates are maintained.REC name
Wales REC 3
REC reference
14/WA/1118
Date of REC Opinion
24 Oct 2014
REC opinion
Further Information Favourable Opinion