A Phase II Study of Parotid-gland Sparing IMRT in Patients With Midline Tumour of the Head and Neck

Royal Marsden NHS Foundation Trust120 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Oropharyngeal Squamous Cell Cancer Hypopharyngeal Squamous Cell Cancer

Interventions

Intensity modulated radiotherapyRADIATION

Bilateral superficial lobe parotid sparing intensity modulated radiotherapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Head and Neck Unit, Royal Marsden Hospital

London, United Kingdom

Outcomes

Primary Outcomes

The proportion of patients reporting grade 2 or more xerostomia using subjective measure on the LENTSOMA late toxicity scoring scale one year after treatment.

Time frame: 12 months

Secondary Outcomes

Acute radiation toxicity

Time frame: 0-3 months

Late radiation toxicity

Time frame: 3-24 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.

Time frame: 24 months

Data from ClinicalTrials.gov

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