A clinical trial to investigate reduced intensity post-operative treatment for HPV positive throat cancer

• Conditions: Oropharyngeal cancer; MedDRA version: 18.1Level: PTClassification code 10031096Term: Oropharyngeal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-003392-32-GB
• Lead Sponsor: Velindre NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-27
• Last Update Posted: 11 January 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 242

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified