MR-Linac for Head and Neck SBRT

Magnetic Resonance Imaging-Guided Radiotherapy for Head & Neck SBRT on the 1.5T MR-Linac

This study will evaluate the feasibility and safety of using MR-guided adaptive Head and Neck stereotactic radiotherapy (SBRT) at each fraction on the 1.5T MR-Linac.

Study Overview

• Status: Not yet recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Radiation: SBRT on the MR-Linac

Detailed Description

At the Sunnybrook Odette Cancer Centre (OCC), stereotactic body radiation therapy (SBRT) (35- 50 Gy in 5 fractions delivered 2x/week) has been employed in a subgroup of palliative Head and Neck cancer (HNC) patients, as part of an institutional protocol, when greater tumor response is desirable when compared to more palliative regimens.

The MR-Linac has been approved by Health Canada for radiation treatment. With superior soft tissue contrast and the possibility for daily plan adaptation, it allows for higher treatment precision delivery, improved target coverage and greater normal tissue sparing.

As a first step, this study will evaluate the feasibility and safety of using the 1.5T MR-Linac on patients with HNC who are treated with SBRT.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Madette Galapin; Phone Number: 89638 (416) 480-6100; Email: Madette.Galapin@sunnybrook.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients aged 18 years and older
• Karnofsky performance status score of ≥70
• Biopsy-proven oligometastatic cancer to the HN
• Biopsy-proven primary HN cancer (either mucosal, nodal, skin)
• Patients deemed unsuitable by the treating radiation oncologist for radiation treatment with curative intent owing to advanced age, significant comorbidities, poor performance status, distant metastatic disease.
• ≥ 1 site amenable to HN SBRT
• Capable of providing informed consent
• Required to complete any systemic therapy ≥ 10 days prior to planned start of HN SBRT, with no plans to initiate systemic therapy ≥10 days following completion of HN SBRT.

Exclusion Criteria:

• History of radiation within the projected treatment field
• Contraindications to MR imaging per institutional policy
• Patients with connective tissue disorders
• History of severe claustrophobia
• Pregnant and or breastfeeding females
• Having an estimated glomerular filtration rate (GFR) <40 ml/min/1.73m2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Head and neck cancer; In this arm patients with head and neck cancers treated with SBRT are recruited.	Radiation: SBRT on the MR-Linac; Radiotherapy is performed on the 1.5 T MR Linac

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who complete ≥80% of treatment fractions in ≤60 minutes.	Clinical feasibility of delivering radiotherapy treatment on the MR Linac within 60 minutes and the need for patients to transfer to a CT-based linear accelerator will be monitored. The radiotherapy timing sheet will be used to record the length of time for patients to have their MR guided adaptive radiotherapy for each fraction.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosimetric outcomes in HN SBRT patients treated with MR-guided adaptation as compared to non-adaptive HN SBRT.	Prospectively recorded OAR dose, cumulative GTV/PTV dose, and projected dose that would have been delivered by non-adaptive plans.	2 years
Number of participants with Acute and Late Toxicity	Acute toxicity (during and up to 3 months from the end of treatment) and late toxicity (after 3 months) secondary to SBRT will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0) scale.	2 years
Quality of Life as measured by the MD Anderson Symptom Inventory - Head and Neck (MDASI-HN)	Patient Reported Outcome (PRO) measure of symptoms	2 years
Quality of Life as measured by the MD Anderson Dysphagia Inventory (MDADI)	Patient Reported Outcome (PRO) measure of symptoms	2 years
Quality of Life as measured by the Xerostomia Questionnaire (XQ)	Patient Reported Outcome (PRO) measure of symptoms	2 years
Quality of Life as measured by the Patient experience Questionnaire for MR-Linac	Patient Reported Outcome (PRO) measure of symptoms	2 years
Locoregional control 6 months based on RECIST criteria 1.1 and assessed on MRI or CT scan imaging	Calculated from time of treatment completion to disease progression at primary site or regional lymph nodes	6 months
Progression-free survival	Calculated as time from diagnosis to either death or detection of recurrent disease	2 years
Overall survival	Calculated as time from diagnosis to either death or last follow-up	2 years
Changes in tumor apparent diffusion coefficient (ADC) maps from diffusion weighted (DWI) MRI scan at baseline and at each fraction	Functional imaging kinetics as a correlate of treatment response	2 years

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Irene Karam, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): June 1, 2025
• Study Completion (Anticipated): June 1, 2030

Study Registration Dates

• First Submitted: March 15, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Adaptive radiotherapy
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 1509

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No