RecruitingNot ApplicableNCT07348887

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)


Sponsor

University Health Network, Toronto

Enrollment

50 participants

Start Date

Oct 15, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a technique called daily adaptive radiotherapy for head and neck cancer that aims to protect the submandibular glands (saliva glands under the jaw) from radiation damage. When these glands are damaged, it can cause permanent dry mouth. Adaptive radiotherapy adjusts the radiation plan daily based on changes in the patient's anatomy to better avoid healthy tissue. **You may be eligible if...** - You are 18 or older - You have confirmed squamous cell carcinoma of the head and neck - Both sides of your neck are included in the radiation treatment area - You are planned for curative radiotherapy (with or without chemotherapy) - You are able to lie comfortably for up to 1 hour in the radiation mask **You may NOT be eligible if...** - You have evidence of disease that has spread beyond the head and neck region - You are pregnant - You already have salivary gland problems before treatment that would reduce benefit from this approach Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONDaily 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

RADIATIONImage guided radiation therapy

The pre-treatment reference plan will be delivered daily for 35 fractions.


Locations(1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

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NCT07348887


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