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Phase II Study of Daily Adaptive Radiotherapy for Submandibular Gland-sparing in Head and Neck Cancer

ConditionSquamous Cell Cancer of Head and Neck (SCCHN)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Daily adaptive radiation therapy

    Radiation

    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

  • Image guided radiation therapy

    Radiation

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Image guided radiation therapyActive comparator 1 intervention
Group B: Daily Adaptive Radiation TherapyExperimental treatment 1 intervention

Trial outcomes

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

Time frame
6 months

Secondary outcomes

1

Change in saliva production

Saliva production measured by MST (Malnutrition Screening Test) during radiotherapy and at 1.5, 12 and 24 months

Time frame
24 months
2

MDADI (MD Anderson Dysphagia Inventory)

Patient reported outcomes at baseline, end of treatment and 1.5, 6, 12 and 24 months. Low score means low functioning. High score means high functioning/healthy.

Time frame
24 months
3

Swallow assessment

Swallow assessment via performance status scale (PSS) for Head and Neck Cancer (PSS-HNC) at baseline, end of treatment and 1.5, 6, 12 and 24 months. Higher score means high functional/healthy.

Time frame
24 months
4

Toxicity assessment

Clinician assessed toxicity at baseline, weekly during radiotherapy and 1.5, 6, 12,and 24 months (CTCAE v5). Low grade side toxicity and less number of toxicities means patients are healthier compared to high grade and high number of toxicities.

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov
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