A Phase II Study of Parotid-gland Sparing IMRT in Patients With Midline Tumour of the Head and Neck
Completed
- Conditions
- Oropharyngeal Squamous Cell CancerHypopharyngeal Squamous Cell Cancer
- Interventions
- Radiation: Intensity modulated radiotherapy
- Registration Number
- NCT02149602
- Lead Sponsor
- Royal Marsden NHS Foundation Trust
- Brief Summary
This study is a phase II trial designed to test the feasibility of delivering IMRT to head and neck cancer patients with tumours arising in the midline (oropharynx and hypopharynx), and to assess possible improvement in reducing the incidence of xerostomia with bilateral superficial lobe parotid sparing IMRT.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- histologically confirmed locally advanced HNSCC arising from the oropharynx or hypopharynx with high risk of bilateral parapharyngeal space involvement
Exclusion Criteria
- Patients <18 years old or with a previous malignancy other than non-melanomatous skin cancer
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description oropharyngeal and hypopharyngeal HNSCC Intensity modulated radiotherapy Intensity Modulated Radiotherapy HPV positive and HPV negative
- Primary Outcome Measures
Name Time Method The proportion of patients reporting grade 2 or more xerostomia using subjective measure on the LENTSOMA late toxicity scoring scale one year after treatment. 12 months
- Secondary Outcome Measures
Name Time Method Late radiation toxicity 3-24 months Acute radiation toxicity 0-3 months Survival outcomes for entire cohort and according to HPV status where available : Local control, Loco regional control, Loco-regional progression-free survival (LRPFS), Disease free survival, Overall survival. 24 months
Trial Locations
- Locations (1)
Head and Neck Unit, Royal Marsden Hospital
🇬🇧London, United Kingdom