Clinical trial · Interventional
Phase II Study of Daily Adaptive Radiotherapy for Submandibular Gland-sparing 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)
NCT07348887CI-TRIAL-00104640RTL-DARTrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Cancer of Head and Neck (SCCHN) | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Daily adaptive radiation therapy | Radiation | — | UNRESOLVED |
| Image guided radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Image guided radiation therapy
- description
- 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
- interventionNames
- Radiation: Image guided radiation therapy
- type
- EXPERIMENTAL
- label
- Daily Adaptive Radiation Therapy
- description
- 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.
- interventionNames
- Radiation: Daily adaptive radiation therapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.