Phase II Study of Daily Adaptive Radiotherapy for Submandibular Gland-sparing in Head and Neck Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Daily adaptive radiation therapy, Image guided radiation therapy.
- Who it may be relevant to
- Registry conditions: Squamous Cell Cancer of Head and Neck (SCCHN). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase II Randomized Trial of RT-Led Daily Adaptive Radiotherapy for Submandibular Gland-Sparing in Head and Neck Cancer (RTL-DART)
Overview
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.
Interventions
- 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.
Primary outcome measures
- Change in saliva production [Time frame: 6 months]
Secondary outcome measures (8)
- Change in saliva production [Time frame: 24 months]
- MDADI (MD Anderson Dysphagia Inventory) [Time frame: 24 months]
- Swallow assessment [Time frame: 24 months]
- Toxicity assessment [Time frame: 24 months]
- Comparing dental health between two arms [Time frame: 24 months]
- Procedure delivery comparison [Time frame: 24 months]
- Xerostomia questionnaire [Time frame: 24 months]
- EORTC QLQ HN43 (Quality of Life Questionnaire Head and Neck 43) [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Princess Margaret Cancer Centre — Toronto
Identifiers
NCT: NCT07348887 · 25-5273