Improving patient experience in head and neck cancer radiation therapy
A Phase 3 Study Optimising Patient Experience in Head and Neck Radiotherapy
PHASE3 · Irish Research Radiation Oncology Group · NCT06327139
This study tests which of three different mask types helps head and neck cancer patients feel more comfortable and accurately positioned during radiation therapy.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 201 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Irish Research Radiation Oncology Group (network) |
| Drugs / interventions | radiation |
| Locations | 1 site (Dublin) |
| Trial ID | NCT06327139 on ClinicalTrials.gov |
What this trial studies
This phase III trial evaluates the setup accuracy of three immobilization methods for head and neck cancer patients undergoing radical radiation therapy. It compares two types of open-faced masks with a conventional closed-faced mask, measuring translational corrections using daily cone beam computed tomography (CBCT). The study also assesses patient distress levels associated with each immobilization device. A total of 198 patients will be enrolled, each receiving a minimum of 30 fractions of radiation therapy over an expected one-year enrollment period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are planned to receive 30-35 fractions of radical radiation therapy for head and neck cancer.
Not a fit: Patients who cannot tolerate or proceed with treatment using a closed mask will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the comfort and treatment accuracy for patients undergoing radiation therapy for head and neck cancer.
How similar studies have performed: Other studies have explored various immobilization techniques in radiation therapy, but this specific comparison of faceless masks is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. All radical H\&N patients receiving 30-35 fractions of Radiotherapy 2. Written informed consent obtained prior to any study-specific procedures 3. ≥18 years of age Exclusion Criteria: 1) Patient who from the outset who would not tolerate or would be unable to proceed with treatment if placed in a closed mask, at the discretion of either the patient or the clinician.
Where this trial is running
Dublin
- St. Luke's Radiation Oncology Network — Dublin, Ireland (RECRUITING)
Study contacts
- Study coordinator: Roisin O Maolalai
- Email: Roisin.OMaolalai@slh.ie
- Phone: 0035314065000
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.
Conditions: Head and Neck Cancer, Radiation Therapy, Set-up Accuracy, Faceless Mask, Immobilisation, Quality of Life