NCT07348887

Phase II Study of Daily Adaptive Radiotherapy for Submandibular Gland-sparing in Head and Neck Cancer

Phase II Randomized Trial of RT-Led Daily Adaptive Radiotherapy for Submandibular Gland-Sparing in Head and Neck Cancer (RTL-DART)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, single centre, single blinded prospective study comparing the standard of care imaging guided radiation therapy and daily adaptive radiotherapy (ART) for submandibular gland-sparing in head and neck cancer

Detailed description

This study will recruit up to 50 patients planned to receive curative (chemo) radiotherapy for (head and neck squamous cell carcinoma) HNSCC with at least one level 1b lesion not being treated electively and with no high dose structure \<1cm to spared (submandibular gland) SMG. The effect of daily ART with SMG dose sparing will be studied using both doimetric analysis and externally-validated quantitative metrics of unstimulated salivary flow as an object assessment for submandibular gland function. Patient report outcomes will assess the effect of the intervention on self-reported quality of life following treatment. Patients, at the time of enrollment, will be randomized into one of the two treatment arms. The patients will be blinded to prevent bias in their quality of life assessments. Patients in both arms will undergo a baseline functional CT scan along with other assessments including oral and dental assessment, PSS-HNC swallow assessment, unstimulated salivary flow rate test, DMFS160 index, and quality of life questionnaire. The radiation treatment will take approximately 7 weeks to complete. The follow up visits will be at 1.5, 6, 12, and 24 months with assessments similar to baseline.

Conditions

• Squamous Cell Cancer of Head and Neck (SCCHN)

Interventions

Type	Name	Description
RADIATION	Daily adaptive radiation therapy	Adaptive radiotherapy (ART) is the modification of the radiotherapy plan during treatment to account of changes from the original anatomy and set up. Reduction in treatment volume can be achieved through ART by: 1. adjusting for gradual longitudinal changes in tumour and anatomy 2. adjusting to account for uncertainty in set up and anatomy via daily online
RADIATION	Image guided radiation therapy	The pre-treatment reference plan will be delivered daily for 35 fractions.

Timeline

• Start date: 2025-10-15
• Primary completion: 2029-10-01
• Completion: 2029-10-01
• First posted: 2026-01-16
• Last updated: 2026-03-04

Locations

1 site across 1 country: Canada