Clinical trial · Observational
The GOAL27-6 Study
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
NCT05859828CI-TRIAL-00069097unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Head and Neck Cancer patients
- description
- Participants with incurable advanced head and neck cancer. Participants will have histologically or cytologically confirmed squamous cell carcinoma of the head and neck
- label
- Patient Caregivers
- description
- Caregivers to participants in the patient cohort
Primary outcomes (2)
- 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
- description
- measured via scores on validated FACT-HN questionnaire
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.