The GOAL27-6 Study

Trial Title: The GOAL27-6 Study

NCT ID: NCT05859828

Condition: Head and Neck Cancer

Conditions: Official terms:
Head and Neck Neoplasms

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

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

Criteria for eligibility:

Study pop:
Head and neck squamous cell cancer patients, where palliative radiotherapy is the treatment. Up to 30 carers will also be recruited.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - Aged 18 and over - Histologically or cytologically confirmed squamous cell carcinoma of the head and neck - Neck disease from cutaneous squamous cell carcinoma of head and neck area - Measurable disease on clinical examination (e.g. transoral examination, neck palpation) for post-radiotherapy comparison or if no assessable disease at baseline, patient will have disease amenable to post-radiotherapy investigations of response per SOC - Patients not clinically deemed to be suitable for radical / curative surgery or radiotherapy - Life expectancy of at least 3 months - Patient due to undergo 27Gy in 6f palliative radiotherapy outside the study - Capable of providing written or witnessed informed consent according to ICH/GCP and national/local guidelines prior to registration - Patients consent to hospital and/or community palliative care referrals Inclusion Criteria for carers - consent is needed from the patient for carer involvement - carers should have adequate command of English language to read and answer questionnaires - capable of at least providing written or witnessed informed consent Exclusion Criteria: - Non squamous cell carcinoma of the head and neck - Previous radiotherapy to the head and neck - Palliative systemic treatment (chemotherapy/immunotherapy) given prior to palliative radiotherapy. Subsequent systemic treatment is allowed on progression of disease after palliative radiotherapy. - ECOG performance status 4 - Any psychological, familial, sociological or geographical condition in patients or carers potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the participant before registration in the study

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Mount Vernon Cancer Centre

Address:
City: Northwood
Zip: HA62RN
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Rishma Bhaati

Phone: 02038262075
Email: mvccresearch.enh-tr@nhs.net

Investigator:
Last name: Kevin Chiu, Dr
Email: Principal Investigator

Start date: April 21, 2022

Completion date: April 21, 2025

Lead sponsor:
Agency: East and North Hertfordshire NHS Trust
Agency class: Other

Collaborator:
Agency: Get A-Head Charitable Trust
Agency class: Other

Source: East and North Hertfordshire NHS Trust

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05859828