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NCT Number: NCT07348887

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

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

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Key information

Conditions

Squamous Cell Cancer of Head and Neck (SCCHN)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location status: Recruiting

Location contact

Andrew McPartlin, MD

CONTACT

[email protected]

416-946-4501 ext. 4855

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Daily adaptive radiation therapy

Radiation

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:

  • adjusting for gradual longitudinal changes in tumour and anatomy
  • adjusting to account for uncertainty in set up and anatomy via daily online

Other names: Daily ART, DART

Image Guided Radiation Therapy

Radiation

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

Other names: IGRT

Primary outcomes

  1. Change in saliva production

    Time frame: 6 months

    Change in saliva production from baseline measured by MST (Malnutrition Screening Test) at 6 months following IGRT or daily ART HN treatment

Secondary outcomes

  1. Change in saliva production

    Time frame: 24 months

    Saliva production measured by MST (Malnutrition Screening Test) during radiotherapy and at 1.5, 12 and 24 months

  2. MDADI (MD Anderson Dysphagia Inventory)

    Time frame: 24 months

    Patient reported outcomes at baseline, end of treatment and 1.5, 6, 12 and 24 months. Low score means low functioning. High score means high functioning/healthy.

  3. Swallow assessment

    Time frame: 24 months

    Swallow assessment via performance status scale (PSS) for Head and Neck Cancer (PSS-HNC) at baseline, end of treatment and 1.5, 6, 12 and 24 months. Higher score means high functional/healthy.

  4. Toxicity assessment

    Time frame: 24 months

    Clinician assessed toxicity at baseline, weekly during radiotherapy and 1.5, 6, 12,and 24 months (CTCAE v5). Low grade side toxicity and less number of toxicities means patients are healthier compared to high grade and high number of toxicities.

  5. Comparing dental health between two arms

    Time frame: 24 months

    Dental health following treatment (Dental assessment + DMFS 160 index). DMFS stands for Decayed, Missing, Filled Surfaces. Low score means healthy teeth and gums.

  6. Procedure delivery comparison

    Time frame: 24 months

    Analysis of average time and staff requirements to deliver daily ART versus IGRT

  7. Xerostomia questionnaire

    Time frame: 24 months

    Patient reported qualitative measurements at baseline, end of treatment and 1.5, 6, 12 and 24 months. Lower score means that patients are producing an adequate amount of saliva. High score means their mouths are dry.

  8. EORTC QLQ HN43 (Quality of Life Questionnaire Head and Neck 43)

    Time frame: 24 months

    Patient reported qualitative measurements at baseline, end of treatment and 1.5, 6, 12 and 24 months. Low score means that patients do not have problems in their daily life. High score means they are having more difficulties.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew McPartlin, MD

CONTACT

[email protected]

416-946-2132

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: RTL-DART

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jan 16, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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