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

University Health Network, Toronto50 enrolled

Overview

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

This study will recruit up to 50 patients planned to receive curative (chemo) radiotherapy for (head and neck squamous cell carcinoma) HNSCC with at least one level 1b lesion not being treated electively and with no high dose structure \<1cm to spared (submandibular gland) SMG. The effect of daily ART with SMG dose sparing will be studied using both doimetric analysis and externally-validated quantitative metrics of unstimulated salivary flow as an object assessment for submandibular gland function. Patient report outcomes will assess the effect of the intervention on self-reported quality of life following treatment. Patients, at the time of enrollment, will be randomized into one of the two treatment arms. The patients will be blinded to prevent bias in their quality of life assessments. Patients in both arms will undergo a baseline functional CT scan along with other assessments including oral and dental assessment, PSS-HNC swallow assessment, unstimulated salivary flow rate test, DMFS160 index, and quality of life questionnaire. The radiation treatment will take approximately 7 weeks to complete. The follow up visits will be at 1.5, 6, 12, and 24 months with assessments similar to baseline.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Squamous Cell Cancer of Head and Neck (SCCHN)

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

Image guided radiation therapyRADIATION

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

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

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

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

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

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

Comparing dental health between two arms

Dental health following treatment (Dental assessment + DMFS 160 index). DMFS stands for Decayed, Missing, Filled Surfaces. Low score means healthy teeth and gums.

Time frame: 24 months

Procedure delivery comparison

Central Contacts

Andrew McPartlin, MD

CONTACT

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

Data from ClinicalTrials.gov

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