Head and Neck CancerNCT05859828
The GOAL27-6 Study
An observational study of Head and Neck Cancer, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Apr 2022to 21 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Head and neck squamous cell cancer patients, where palliative radiotherapy is the treatment. Up to 30 carers will also be recruited.
Who may be able to join
- 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
Show all 12Show fewer
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Mount Vernon Cancer Centre
Northwood, Middlesex, HA62RN
Rishma Bhaati, 02038262075, mvccresearch.enh-tr@nhs.net
Kevin Chiu, Dr
About this 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
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.
Read the 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
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Head and Neck Cancer patients | Participants with incurable advanced head and neck cancer. Participants will have histologically or cytologically confirmed squamous cell carcinoma of the head and neck | |
| Patient Caregivers | Caregivers to participants in the patient cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient quality of life (QoL) in head and neck cancer patients receiving 27 Gray (Gy) in 6 fractions (f) palliative Intensity Modulated Radiotherapy (IMRT).
measured via scores on validated FACT-HN questionnaire
Measured: 12 months
Toxicity (Grade 3 or worse) in head and neck cancer patients receiving 27 Gray (Gy) in 6 fractions (f) palliative Intensity Modulated Radiotherapy (IMRT).
measurement as per Common Terminology Criteria of Adverse Events v5.0
Measured: 12 months
Secondary outcomes (1)
Caregiver quality of life following patients receiving 27Gy in 6f IMRT
Assessed via the CarGoQol questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start21 Apr 2022
- Primary completion21 Apr 2024 (estimated)
- Study completion21 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East and North Hertfordshire NHS Trust
- Sponsor type
- Other government
- Collaborators
- Get A-Head Charitable Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859828
- Sponsor's protocol ID
- RD2021-44
- Status last verified
- Aug 2023
- First submitted
- 5 May 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The research results will be published in international journals and presented at scientific meetings.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05859828
- Acronym / sponsor ID
- RD2021-44
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- East and North Hertfordshire NHS TrustOther government
- Collaborators
- Get A-Head Charitable Trust
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 21 Apr 2024 (estimated)
- Study completion
- 21 Apr 2025 (estimated)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Head and Neck Cancer patients | – | –Participants with incurable advanced head and neck cancer. Participants will have histologically or cytologically confirmed squamous cell carcinoma of the head and neck |
| Patient Caregivers | – | –Caregivers to participants in the patient cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Head and neck squamous cell cancer patients, where palliative radiotherapy is the treatment. Up to 30 carers will also be recruited.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient quality of life (QoL) in head and neck cancer patients receiving 27 Gray (Gy) in 6 fractions (f) palliative Intensity Modulated Radiotherapy (IMRT).
Time frame: 12 months
measured via scores on validated FACT-HN questionnaire
Toxicity (Grade 3 or worse) in head and neck cancer patients receiving 27 Gray (Gy) in 6 fractions (f) palliative Intensity Modulated Radiotherapy (IMRT).
Time frame: 12 months
measurement as per Common Terminology Criteria of Adverse Events v5.0
1 secondary outcome
Caregiver quality of life following patients receiving 27Gy in 6f IMRT
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: Undecided. The research results will be published in international journals and presented at scientific meetings.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kevin Chiu, Dr (02038262020, k.chiu@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.