A study testing a more precise type of radiotherapy for head and neck cancer to reduce long-term side effects

Phase II randomized trial of RT-led daily adaptive radiotherapy for submandibular gland-sparing in head and neck cancer

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN60167386

Enrollment

Registered

2025-11-06

Start date

2025-11-07

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous cell carcinoma of head and neck (HNSCC) Cancer

Interventions

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 rando

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Change in saliva production from baseline measured using the Modified Schirmer Test (MST) at 6 months following IGRT or daily ART HN treatment?	—

Secondary

Measure	Time frame
1. Saliva production measured using the Modified Schirmer Test (MST) during radiotherapy and at 1.5, 12 and 24 months ? 2. Patient-reported outcomes measured using the MD Anderson Dysphagia Inventory (MDADI), xerostomia questionnaire, and European Organisation for Research and Treatment of Cancer (EORTC) QLQ-HN43 at baseline, end of treatment and 1.5, 6, 12 and 24 months 3. Clinician assessed toxicity, according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, measured using data collected from electronic Case Report Forms (eCRF) at baseline, weekly during radiotherapy and 1.5, 6, 12,and 24 months 4. Swallow assessment measured using the Performance Status Scale for Head and Neck Cancer (PSS-HNC) at baseline, end of treatment and 1.5, 6, 12 and 24 months?	—

Measure

Time frame

1. Saliva production measured using the Modified Schirmer Test (MST) during radiotherapy and at 1.5, 12 and 24 months ? 2. Patient-reported outcomes measured using the MD Anderson Dysphagia Inventory (MDADI), xerostomia questionnaire, and European Organisation for Research and Treatment of Cancer (EORTC) QLQ-HN43 at baseline, end of treatment and 1.5, 6, 12 and 24 months 3. Clinician assessed toxicity, according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, measured using data collected from electronic Case Report Forms (eCRF) at baseline, weekly during radiotherapy and 1.5, 6, 12,and 24 months 4. Swallow assessment measured using the Performance Status Scale for Head and Neck Cancer (PSS-HNC) at baseline, end of treatment and 1.5, 6, 12 and 24 months?

—

Countries

Canada

Contacts

Public ContactAndrew McPartlin

andrew.mcpartlin@uhn.ca+1 416-340-4800 ext 4855

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026