The GOAL27-6 Study

NCT05859828 | Unknown

• 1 other identifier: RD2021-44
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (2)

• 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

  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

  12 months

Secondary Outcomes (1)

• Caregiver quality of life following patients receiving 27Gy in 6f IMRT

  12 months

Other Outcomes (2)

• Patient survival following 27 Gray (Gy) in 6 fractions (f) palliative Intensity Modulated Radiotherapy (IMRT).

  12 months

• Patient response following 27 Gray (Gy) in 6 fractions (f) palliative Intensity Modulated Radiotherapy (IMRT).

  12 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• East and North Hertfordshire NHS Trust: lead
• Get A-Head Charitable Trust: collaborator

Study Sites (1)

Mount Vernon Cancer Centre

Northwood, Middlesex, HA62RN, United Kingdom

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Kevin Chiu, Dr

CONTACT

02038262020; k.chiu@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 16, 2023
• Study Start: April 21, 2022
• Primary Completion: April 21, 2024
• Study Completion: April 21, 2025
• Last Updated: August 25, 2023

Record last verified: 2023-08

Locations

GB (1)