NCT07348887

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
40mo left

Started Oct 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Oct 2025Oct 2029

Study Start

First participant enrolled

October 15, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 25, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

4 years

First QC Date

November 25, 2025

Last Update Submit

March 3, 2026

Conditions

Squamous Cell Cancer of Head and Neck (SCCHN)

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Secondary Outcomes (8)

  • Change in saliva production

    24 months

  • MDADI (MD Anderson Dysphagia Inventory)

    24 months

  • Swallow assessment

    24 months

  • Toxicity assessment

    24 months

  • Comparing dental health between two arms

    24 months

  • +3 more secondary outcomes

Study Arms (2)

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

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.

Radiation: Daily adaptive radiation therapy

Interventions

Daily adaptive radiation therapyRADIATION

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: 1. adjusting for gradual longitudinal changes in tumour and anatomy 2. adjusting to account for uncertainty in set up and anatomy via daily online

Also known as: Daily ART, DART
Daily Adaptive Radiation Therapy
Image guided radiation therapyRADIATION

The pre-treatment reference plan will be delivered daily for 35 fractions.

Also known as: IGRT
Image guided radiation therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Interventions

Radiotherapy, Image-Guided

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeutics

Central Study Contacts

Andrew McPartlin, MD

CONTACT

416-946-2132andrew.mcpartlin@uhn.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2025

First Posted

January 16, 2026

Study Start

October 15, 2025

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2029

Last Updated

March 4, 2026

Record last verified: 2026-03

Locations

CA(1)