PATHOS

Trial Info

Status: Open

Specialty: Head & Neck

Date Opened: 23/03/2023

Planned Close Date: 01/10/2024

Sponsor: University Hospitals Bristol and Weston NHS Foundation Trust

Principal Investigator: Mr Chakkyath Jayaram Sharan

Trial Description

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 sideeffects

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 postoperative 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.

Inclusion Criteria

• Histologically confirmed diagnosis of squamous cell carcinoma of the oropharynx.

• HPV positive on central testing.

• UICC TNM (7th edition) stage T1T3, N0N2b tumours of the oropharynx. Staging should be based on cross sectional imaging investigations carried out within 6 weeks of study entry*.

• Local MDT decision to treat with primary transoral resection and neck dissection.

• Patients considered fit for surgery and adjuvant treatment by the local MDT.

• Aged 18 or over.

• Written informed consent provided.

* Please Note: Current smokers with N2b disease (including smokers up to 2 years before diagnosis) are not eligible to be included.

Exclusion Criteria

• HPV negative squamous cell carcinomas of the head and neck.

• Patients with T4 primary oropharyngeal tumours and/or T1T3 tumours where transoral surgery is considered not feasible.

• N2cN3 nodal disease.

• Unresectable retropharyngeal node involvement.

• Current smokers with N2b disease (including smokers up to 2 years before diagnosis).

• Any pre-existing medical condition likely to impair swallowing function and/ or a history of pre-existing swallowing dysfunction.

• Patients with distant metastatic disease (UICC TNM stage IVC disease) as determined by routine preoperative staging radiological investigations e.g., CT thorax and upper abdomen or PETCT.

• 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.

• Pregnant or lactating women and fertile women who will not be using contraception during the trial.

Contacts

Research Nurse: Jessica Westney (x4656) Jessica.Westney@lthtr.nhs.uk

Administrator: Aaisha Khan (x8475)

Link to EDGE

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