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Table 1 Inclusion and exclusion criteria for all patients in PATHOS trial

From: PATHOS: a phase II/III trial of risk-stratified, reduced intensity adjuvant treatment in patients undergoing transoral surgery for Human papillomavirus (HPV) positive oropharyngeal cancer

Inclusion criteria for all patients
1. Histologically confirmed diagnosis of OPSCC
2. HPV-positive on central testing
3. Stage T1-T3, N0-N2b tumours (based on cross-sectional imaging investigations carried out within 6 weeks of study entry)
4. Local MDT decision to treat with primary transoral resection and neck dissection
5. Fit for surgery and adjuvant treatment as assessed by the local MDT
6. Aged 18 or over
7. Able to provide written informed consent
Exclusion criteria for all patients
1. HPV-negative tumours
2. Stage T4 tumours and/or T1–T3 tumours where transoral surgery is considered not feasible
3. N2c–N3 nodal disease
4. Unresectable retropharyngeal node involvement
5. Current smokers with N2b disease including smokers up to 2 years before diagnosis
6. Any pre-existing medical condition likely to impair swallowing function and/or a history of pre-existing swallowing dysfunction prior to index oropharyngeal cancer
7. Patients with distant metastatic disease (stage IVc)
8. 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
9. Women who are pregnant or breastfeeding and fertile women who will not be using contraception during the trial