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)
University Health Network, Toronto
50 participants
Oct 15, 2025
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
Inclusion Criteria8
- Age ≥ 18 years
- Histologically proven Squamous Cell carcinoma of head and neck
- Bilateral neck being treated
- At least one level 1b not being treated electively and with no target structure, other than elective level II/III, \<1cm to spared SMG
- ECOG PS 0-2
- Planned for curative (chemo)radiotherapy
- Able to receive and understand verbal and written information regarding study and able to give written informed consent
- Be able to lie comfortably on back and to wear immobilization for up to 1 hour
Exclusion Criteria3
- As judged by investigator evidence of systemic disease that makes unsuitable for study
- Pregnancy
- Underlying salivary dysfunction prior to treatment judged by investigator to affect likelihood of benefit from ART
Interventions
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
The pre-treatment reference plan will be delivered daily for 35 fractions.
Locations(1)
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NCT07348887