Clinical trial NCT05859828: The GOAL27-6 Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Lead sponsor: East and North Hertfordshire NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: Get A-Head Charitable Trust
First posted: 2023-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Head and neck squamous cell cancer patients, where palliative radiotherapy is the treatment. Up to 30 carers will also be recruited.

Brief 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

Eligibility 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

Primary outcomes:
measure: Patient quality of life (QoL) in head and neck cancer patients receiving 27 Gray (Gy) in 6 fractions (f) palliative Intensity Modulated Radiotherapy (IMRT).
timeFrame: 12 months
measure: Toxicity (Grade 3 or worse) in head and neck cancer patients receiving 27 Gray (Gy) in 6 fractions (f) palliative Intensity Modulated Radiotherapy (IMRT).
timeFrame: 12 months
Secondary outcomes:
measure: Caregiver quality of life following patients receiving 27Gy in 6f IMRT
timeFrame: 12 months
Other outcomes:
measure: Patient survival following 27 Gray (Gy) in 6 fractions (f) palliative Intensity Modulated Radiotherapy (IMRT).
timeFrame: 12 months
measure: Patient response following 27 Gray (Gy) in 6 fractions (f) palliative Intensity Modulated Radiotherapy (IMRT).
timeFrame: 12 months
Locations:
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre
state: Middlesex
Study officials:
References: