A Phase 3 trial optimizing patient experience in Head and Neck Radiotherapy for Head and Neck Cancer reached primary completion on 2025-05-31, enrolling 201 participants.
Background
Head and Neck Cancer encompasses a group of cancers that originate in the mouth, throat, voice box, sinuses, and salivary glands. Treatment often involves radical radiation therapy, which requires precise targeting to maximize tumor eradication while minimizing damage to surrounding healthy tissues. Accurate patient immobilization is critical during radiotherapy sessions to ensure consistent positioning and delivery of radiation doses. Conventional immobilization methods, such as closed-faced masks, can sometimes be uncomfortable for patients, potentially affecting compliance and treatment accuracy. Investigating alternative immobilization techniques, like open-faced masks combined with intra-fraction surface guided monitoring, aims to improve both the accuracy of treatment setup and the overall patient experience during a demanding course of therapy.
Trial design
This completed study, identified as Phase PHASE3, enrolled 201 participants with Head and Neck Cancer. The trial is a randomized, single-centre, multiple-arm study designed to examine the set-up accuracy of three different types of immobilization methods for patients receiving radical radiation therapy. The methods under investigation include two types of open-faced head and neck masks, compared against a conventional closed-faced head and neck mask. Patients treated with an open-faced mask will also have their intra-fraction motion monitored using surface-guided technology. The study's primary objective is to determine the set-up accuracy of these immobilization techniques.
What this means
The primary completion of this Phase 3 trial signifies that data collection for its main objectives regarding immobilization methods in Head and Neck Cancer radiotherapy is complete. The study's focus on comparing different mask types and incorporating intra-fraction surface guided monitoring suggests an effort to enhance both the precision of radiation delivery and patient comfort. The findings from this trial could provide valuable insights into optimizing radiotherapy protocols, potentially leading to improved treatment outcomes and a better experience for patients undergoing radiation therapy for Head and Neck Cancer.
Source
The information regarding this trial's primary completion was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for the study NCT06327139, titled "Optimising Patient Experience in Head and Neck Radiotherapy", was posted on 2025-05-31 on clinicaltrials.gov.