Phase II Study of Daily Adaptive Radiotherapy for Submandibular Gland-sparing in Head and Neck Cancer
NCT ID: NCT07348887
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-10-15
2029-10-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Image guided radiation therapy
This arm will proceed as per the standard of care. The pre-treatment reference plan will be delivered daily for 35 fractions. If a notable change in anatomy is identified, a dose of the day calculation may be performed as per current standard head and neck workflow
Image guided radiation therapy
The pre-treatment reference plan will be delivered daily for 35 fractions.
Daily Adaptive Radiation Therapy
Structures of daily adaptive radiation therapy organ at risk will be AI generated in the Ethos platform on the daily CBCT and then edited by radiation therapy team as required. A rigid registration of CTV targets to the CBCT replicating the current radiation therapy led IGRT process.
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
Interventions
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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
Image guided radiation therapy
The pre-treatment reference plan will be delivered daily for 35 fractions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically proven Squamous Cell carcinoma of head and neck
* At least one level 1b not being treated electively and with no high dose structure \<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 Criteria
* Pregnancy
* Underlying salivary dysfunction prior to treatment judged by investigator to affect likelihood of benefit from ART
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Locations
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Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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25-5273
Identifier Type: -
Identifier Source: org_study_id
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