A study testing a more precise type of radiotherapy for head and neck cancer to reduce long-term side effects
| ISRCTN | ISRCTN60167386 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60167386 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | University Health Network |
| Funder | Varian Medical Systems |
- Submission date
- 04/11/2025
- Registration date
- 06/11/2025
- Last edited
- 07/11/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Head and neck radiotherapy has a small efficacy. Adaptive radiotherapy (ART) has the potential to improve this, but has failed to deliver meaningful outcome benefits and/or required non-scalable daily Radiation Oncologist input. To drive routine adoption, ART must achieve measurable clinical benefit without requiring significant changes to the current radiotherapy delivery staffing resources. We will investigate first-in-kind daily Radiotherapist-led ART-enabled Target Volume margin reduction and salivary glands sparing to deliver clinically meaningful reductions in xerostomia. This study will leverage our institutional expertise and experience in radiotherapy-led Magnetic Resonance Lymphangiography ART and is anticipated to demonstrate clinical benefit from a world-first RT-led Head and Neck ART workflow.
Who can participate?
Patients aged at least 18 years old and diagnosed with head and neck squamous cell carcinoma who are planned for curative (chemo)therapy and have at least one level 1b that has not been treated.
What does the study involve?
This study involves participants being randomly assigned to either a control group or an ART group. They will be blinded to the treatment as they will be completing quality-of-life questionnaires, and we don't expect any bias in their responses. This study is only open at Princess Margaret Hospital in Toronto, ON, Canada. The participation will last approximately 7 weeks, but may vary slightly depending on your treatment needs.
What are the possible benefits and risks of participating?
There are no direct benefits to participating in the study, as we don't know how beneficial ART is. The risks of participating are the same as the standard of care palliative radiation therapies for both the control and the ART group.
Where is the study run from?
University Health Network, Canada.
When is the study starting and how long is it expected to run for?
July 2025 to November 2028
Who is funding the study?
Varian Medical Systems, USA
Who is the main contact?
Dr Andrew McPartlin, andrew.mcpartlin@uhn.ca
Contact information
Public, Scientific, Principal investigator
OPG Building, 700 University Avenue, 7th Floor
Toronto
M5G 1Z5
Canada
| Phone | +1 416-340-4800 ext 4855 |
|---|---|
| andrew.mcpartlin@uhn.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-blinded site, phase II randomized study |
| Secondary study design | Randomised controlled trial |
| Scientific title | Phase II randomized trial of RT-led daily adaptive radiotherapy for submandibular gland-sparing in head and neck cancer |
| Study acronym | RTL-DART |
| Study objectives | 1. Analyze dose sparing to organs at risk achieved by daily ART 2. Assess the effect of SMG dose sparing on repeat MST assessment 3. Assess clinician and patient-reported outcomes before and following treatment Hypotheses: RT-led daily ART 1. Reduces the delivered dose to organs at risk 2. Improves unstimulated salivary flow following radiotherapy 3. Improves patient-reported outcome measures following treatment |
| Ethics approval(s) |
Approved 18/07/2025, University Health Network Research Ethics Board (UHN REB) (700 University Ave, 4th Floor, Toronto, M5G 1Z5, Canada; +1 416-581-7849; reb@uhnresearch.ca), ref: 25-5273 |
| Health condition(s) or problem(s) studied | Squamous cell carcinoma of head and neck (HNSCC) |
| Intervention | This is a single-blinded, phase II randomized study that compares daily adaptive radiation therapy to the standard of care palliative radiation therapy. Randomization will be performed using the randomization module of the REDCap electronic research data capture software. Daily adaptive radiotherapy (ART): modification of the radiotherapy plan during treatment to account for changes from the original anatomy and set-up. Broadly, reductions in treatment volume can be achieved through ART by: 1. Adjusting for gradual longitudinal changes in tumor and anatomy through several weeks of treatment via intermittent offline (performed between treatments) re-planning. 2. Improving plan conformality and reducing treatment volumes by adjusting to account for uncertainty in set-up and anatomy via daily online (performed while the patient is on the treatment couch) re-planning |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Change in saliva production from baseline measured using the Modified Schirmer Test (MST) at 6 months following IGRT or daily ART HN treatment |
| Key secondary outcome measure(s) |
1. Saliva production measured using the Modified Schirmer Test (MST) during radiotherapy and at 1.5, 12 and 24 months |
| Completion date | 01/11/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | 1. Age ≥ 18 years 2. Histologically proven Squamous Cell carcinoma of head and neck 3. At least one level 1b not being treated electively and with no high dose structure <1cm to spared SMG 4. ECOG PS 0-2 5. Planned for curative (chemo)radiotherapy 6. Able to receive and understand verbal and written information regarding study and able to give written informed consent 7. Be able to lie comfortably on back and to wear immobilization for up to 1 hour |
| Key exclusion criteria | 1. As judged by the investigator, evidence of systemic disease that makes them unsuitable for study 2. Pregnancy 3. Underlying salivary dysfunction prior to treatment judged by the investigator to affect the likelihood of benefit from ART |
| Date of first enrolment | 07/11/2025 |
| Date of final enrolment | 01/11/2028 |
Locations
Countries of recruitment
- Canada
Study participating centre
Toronto
M5G 2C4
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available |
Editorial Notes
07/11/2025: The public title was updated from "A study testing a safer, more precise type of radiotherapy for head and neck cancer" to "A study testing a more precise type of radiotherapy for head and neck cancer to reduce long-term side effects".
05/11/2025: Study's existence confirmed by the University Health Network, Canada's Hospital, Research Ethics Board, Canada.
