NCT05859828

The GOAL27-6 Study

A sinGle-arm Phase 2 Study to Assess Efficacy, tOxicity, and quAlity of Life Following 27Gy in 6 Fractions Palliative Intensity Modulated Radiotherapy in Advanced Head and Neck Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: East and North Hertfordshire NHS Trust · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The main purpose and goal of this study is to find out if a particular course of radiotherapy for non-curable cancers, together with palliative care support, can help improve patients' quality of life.

Detailed description

Approximately a quarter of head and neck cancer patients are unfortunately not deemed curable. This is either due to the late advanced nature of the cancer at presentation, or patient's limited medical fitness to go through the intensive curative treatment. With the incurable growing cancer, these patients commonly have debilitating symptoms such as pain, discharge or bleeding that could adversely affect their quality of life and that of their caregivers. As well as palliative care input, palliative radiotherapy is given with the aim of relieving these symptoms. There is a wide variation in the palliative radiotherapy practice locally and internationally. Despite the differences, the paradigm certainly is that higher dose radiotherapy does not necessarily mean better palliation, as high dose radiation itself could lead to more treatment toxicity, which could affect the quality of patients' limited life expectancy. Intensity modulated radiotherapy (IMRT) is a more precise treatment known to offer fewer toxicity than the traditional (non-IMRT) radiotherapy. Not all centres in the UK offer palliative head and neck radiotherapy using IMRT. As a high volume centre, Mount Vernon has the experience of delivering palliative head and neck IMRT almost as quick as the non-IMRT technique. One of the departmental palliative regimens is 27Gy in 6 fractions, with treatment twice a week for 3 weeks. Since the implementation of IMRT with for this dose fractionation in 2019, there has been noticeable improvement in patients' quality of life as well as their caregivers. This is however anecdotal, and the aim of this study is to objectively evaluate this practice using validated quality of life questionnaires

Conditions

• Head and Neck Cancer

Timeline

• Start date: 2022-04-21
• Primary completion: 2024-04-21
• Completion: 2025-04-21
• First posted: 2023-05-16
• Last updated: 2023-08-25

Locations

1 site across 1 country: United Kingdom