A Phase II/III trial of risk-stratified, reduced intensity adjuvant treatment in patients undergoing transoral surgery for Human papillomavirus (HPV)-positive oropharyngeal cancer - Post-operative adjuvant treatment for HPV-positive tumours (PATHOS)

Velindre NHS Trust0 个研究点目标入组 242 人开始时间: 2014年8月27日最近更新: 2016年1月11日

适应症

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•Histologically confirmed diagnosis of squamous cell carcinoma of the oropharynx.
•HPV positive on central testing.
•UICC TNM (7th edition) stage T1-T3, N0-N2b 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 145
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 99

•HPV negative squamous cell carcinomas of the head and neck.
•Patients with T4 primary oropharyngeal tumours and/or T1-T3 tumours where transoral surgery is considered not feasible.
•N2c-N3 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 pre-operative staging radiological investigations e.g., CT thorax and upper abdomen or PET-CT.
•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.

发起方

Velindre NHS Trust