Evaluating palliative radiotherapy for non-curable head and neck cancer patients
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
This study is testing a specific type of radiotherapy combined with supportive care to see if it can improve the quality of life for patients with advanced head and neck cancer who can't be cured.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | East and North Hertfordshire NHS Trust Government |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Northwood, Middlesex) |
| Trial ID | NCT05859828 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the impact of a specific palliative radiotherapy regimen, 27Gy in 6 fractions, combined with palliative care support on the quality of life of patients with non-curable head and neck cancer. The study focuses on patients who are not suitable for curative treatments due to advanced disease or limited medical fitness. By utilizing intensity-modulated radiotherapy (IMRT), which is known for its precision and reduced toxicity, the study seeks to provide insights into effective symptom management for this patient population. The research will involve monitoring patients undergoing this treatment to evaluate their quality of life and symptom relief.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and over with histologically confirmed squamous cell carcinoma of the head and neck who are not suitable for curative treatments.
Not a fit: Patients with curable head and neck cancers or those not undergoing the specified palliative radiotherapy regimen may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance the quality of life for patients with non-curable head and neck cancer by optimizing palliative care approaches.
How similar studies have performed: While there is variability in palliative radiotherapy practices, the use of IMRT for palliative care has shown promise in other studies, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Northwood, Middlesex
- Mount Vernon Cancer Centre — Northwood, Middlesex, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Kevin Chiu, Dr
- Email: k.chiu@nhs.net
- Phone: 02038262020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.