Daily adaptive radiotherapy to spare the submandibular gland in head and neck cancer
Official title: Phase II Randomized Trial of RT-Led Daily Adaptive Radiotherapy for Submandibular Gland-Sparing in Head and Neck Cancer (RTL-DART)
Run by University Health Network, Toronto · NCT07348887 · Data updated 2026-11-12
This study tests whether daily adaptive radiotherapy can better protect the submandibular gland and reduce dry mouth for adults having curative radiotherapy for head and neck squamous cell carcinoma.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | October 15, 2025 |
| Main results expected | October 1, 2029 |
| Study ends | October 1, 2029 |
| Registry record updated | March 4, 2026 |
| Trial ID | NCT07348887 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with histologically proven head and neck squamous cell carcinoma planned for curative (chemo)radiotherapy with bilateral neck treatment, at least one non-electively treated level 1b, suitable anatomy allowing the submandibular gland to be spared (>1 cm from high-dose targets), and ECOG performance status 0–2 are ideal candidates.
✕Probably not a fit
Patients with pre-existing salivary gland dysfunction, metastatic or otherwise unsuitable systemic disease, pregnancy, or anatomy that places the submandibular gland too close to high-dose targets are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, single-centre, single-blinded comparison of standard image-guided radiotherapy versus daily adaptive radiotherapy (ART) aimed at sparing the submandibular gland in patients with head and neck squamous cell carcinoma. Up to 50 patients planned for curative (chemo)radiotherapy with bilateral neck treatment and at least one non-electively treated level 1b will be randomized to one of the two arms. Outcomes include dosimetric comparisons, objective unstimulated salivary flow measurements, and patient-reported quality-of-life measures, with baseline assessments and follow-up at 1.5, 6, 12, and 24 months. Treatment runs about seven weeks and patients are blinded to treatment arm to reduce bias in self-reported outcomes.
Why it matters
Potential benefit: If successful, the approach could lower radiation dose to the submandibular gland, preserve saliva production, and reduce long-term dry mouth and related swallowing problems.
How similar studies have gone: Prior work with IMRT and image-guided techniques has shown that sparing salivary glands can reduce xerostomia, but daily adaptive radiotherapy specifically targeting submandibular gland sparing is relatively new and less extensively proven.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Princess Margaret Cancer Centre
Toronto, Ontario, Canada Recruiting
Study contacts
- Study coordinator: Andrew McPartlin, MD
- Email: andrew.mcpartlin@uhn.ca
- Phone: 416-946-2132
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Safe use of metformin and naproxen to help prevent cancer in people with Fanconi anemia
This study tests whether metformin and naproxen can lower the chance of cancer developing in adults with Fanconi anemia.
-
Nivolumab-IRDyE800CW imaging agent used before surgery in head and neck cancer
This early-stage trial tests whether nivolumab labeled with IRDye800CW can safely be given before surgery to see if it helps image head and neck squamous cell carcinoma.
-
MRI-guided focused ultrasound mesencephalotomy for opioid-resistant head, neck, and brachial cancer pain
This study will try MRI-guided focused ultrasound to make a tiny, precise lesion in the midbrain to relieve severe, opioid-resistant head, neck, or brachial cancer pain.
-
Postoperative cisplatin with radiation versus radiation alone for intermediate‑risk head and neck squamous cell carcinoma
This test sees if adding cisplatin chemotherapy to radiation after surgery helps people with intermediate‑risk head and neck squamous cell carcinoma stay cancer‑free longer and live longer.
-
TMV vaccine alone or with toripalimab for recurrent head and neck cancer
This study tests a personalized TMV vaccine, alone and with toripalimab, in adults whose head and neck cancer has returned and is planning salvage surgery.
-
Ficerafusp alfa with nivolumab in platinum-refractory head and neck cancer
This study tests whether adding ficerafusp alfa to nivolumab helps patients with head and neck squamous cell cancer that progressed after platinum therapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.