Daily adaptive radiotherapy to spare the submandibular gland in head and neck cancer
Phase II Randomized Trial of RT-Led Daily Adaptive Radiotherapy for Submandibular Gland-Sparing in Head and Neck Cancer (RTL-DART)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT07348887 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Toronto, Ontario
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Andrew McPartlin, MD
- Email: andrew.mcpartlin@uhn.ca
- Phone: 416-946-2132
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.