Squamous Cell Cancer of Head and Neck (SCCHN)RTL-DARTNCT07348887
Phase II Study of Daily Adaptive Radiotherapy for Submandibular Gland-sparing in Head and Neck Cancer
A study testing Daily adaptive radiation therapy and Image guided radiation therapy in people with Squamous Cell Cancer of Head and Neck (SCCHN), run by University Health Network, Toronto at 1 site in Canada.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Cancer of Head and Neck (SCCHN)
- What is being tested?
- Daily adaptive radiation therapy and Image guided radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2025to 1 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Andrew McPartlin, MD, 416-946-4501 ext. 4855, andrew.mcpartlin@uhn.ca
About this study
Official title: Phase II Randomized Trial of RT-Led Daily Adaptive Radiotherapy for Submandibular Gland-Sparing in Head and Neck Cancer (RTL-DART)
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
Read the 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.
- Being tested
- Daily adaptive radiation therapy, Image guided radiation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily adaptive radiation therapyRadiation
Also called Daily ART, DART
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
Image guided radiation therapyRadiation
Also called IGRT
The pre-treatment reference plan will be delivered daily for 35 fractions.
| Study group | Role | What they receive |
|---|---|---|
| Image guided radiation therapy | Active comparator | 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 Receives: Radiation: Image guided radiation therapy |
| Daily Adaptive Radiation Therapy | Experimental | 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. Receives: Radiation: Daily adaptive radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in saliva production
Change in saliva production from baseline measured by MST (Malnutrition Screening Test) at 6 months following IGRT or daily ART HN treatment
Measured: 6 months
Secondary outcomes (8)
Change in saliva production
Saliva production measured by MST (Malnutrition Screening Test) during radiotherapy and at 1.5, 12 and 24 months
Measured: 24 months
MDADI (MD Anderson Dysphagia Inventory)
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.
Measured: 24 months
Swallow assessment
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.
Measured: 24 months
Toxicity assessment
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.
Measured: 24 months
Comparing dental health between two arms
Dental health following treatment (Dental assessment + DMFS 160 index). DMFS stands for Decayed, Missing, Filled Surfaces. Low score means healthy teeth and gums.
Measured: 24 months
Procedure delivery comparison
Analysis of average time and staff requirements to deliver daily ART versus IGRT
Measured: 24 months
Xerostomia questionnaire
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.
Measured: 24 months
EORTC QLQ HN43 (Quality of Life Questionnaire Head and Neck 43)
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start15 Oct 2025
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Cancer of Head and Neck (SCCHN)Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348887
- Sponsor's protocol ID
- 25-5273
- Acronym
- RTL-DART
- Status last verified
- Mar 2026
- First submitted
- 25 Nov 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Trial of RT-Led Daily Adaptive Radiotherapy for Submandibular Gland-Sparing in Head and Neck Cancer (RTL-DART)
- ClinicalTrials.gov ID
- NCT07348887
- Acronym / sponsor ID
- RTL-DART / 25-5273
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Image guided radiation therapy | Active comparator | Radiation: Image guided radiation therapyThis 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 |
| Daily Adaptive Radiation Therapy | Experimental | Radiation: Daily adaptive radiation therapyStructures 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily adaptive radiation therapyAlso: Daily ART, DARTAdaptive 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 | Daily Adaptive Radiation Therapy |
| Image guided radiation therapyAlso: IGRTThe pre-treatment reference plan will be delivered daily for 35 fractions. | Radiation | Image guided radiation therapy |
Primary outcome
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
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily adaptive radiation therapy and Image guided radiation therapy in people with Squamous Cell Cancer of Head and Neck (SCCHN), run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew McPartlin, MD (416-946-2132, andrew.mcpartlin@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in saliva production (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.