PRESERVE
Research type
Research Study
Full title
Preservation of Swallowing in Resected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
IRAS ID
277078
Contact name
Claire Paterson
Contact email
Sponsor organisation
London Health Sciences Centre(LHSC)
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 10 months, 0 days
Research summary
The standard or usual treatment for this type and stage of disease is to administer radiation to the entire area the surgeon operated on, including the site of the tumor, the side(s) of the neck from which lymph nodes were removed, and sometimes nearby areas of the neck where lymph nodes were not taken out. Some patients may also be recommended to receive chemotherapy with radiation.
Radiation treatment to the head and neck has many potential side effects, including painful sores in the mouth and throat, irritation and sunburn of the skin, weight loss, difficulty swallowing that may require long-term use of a feeding tube, permanent mouth dryness or taste changes, hoarse voice, and thick saliva. Based on results from previous studies, it has been suggested that giving radiation to a smaller treatment area may help reduce these side effects, without increasing the risk of the cancer coming back.
This study will compare radiation therapy to the standard areas (where the surgeon operated and the neck) vs. radiation therapy to a reduced region where the side(s) of the neck that did not contain any cancer won’t receive radiation. This study aims to determine if treatment side effects will be reduced by making the area treated with radiation smaller.
The purpose of this study is to compare the usual treatment area of radiation to a reduced treatment area to see if radiation to a smaller area on the neck reduces side effects and compare the effectiveness of the two radiation options
REC name
West of Scotland REC 1
REC reference
20/WS/0170
Date of REC Opinion
3 Dec 2020
REC opinion
Favourable Opinion