MR-Linac for Head and Neck SBRT

N/ANot Yet RecruitingNCT04809792

Sunnybrook Health Sciences Centre30 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer

Interventions

SBRT on the MR-LinacRADIATION

Radiotherapy is performed on the 1.5 T MR Linac

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: 2 years

Quality of Life as measured by the MD Anderson Dysphagia Inventory (MDADI)

Patient Reported Outcome (PRO) measure of symptoms

Time frame: 2 years

Quality of Life as measured by the Xerostomia Questionnaire (XQ)

Patient Reported Outcome (PRO) measure of symptoms

Time frame: 2 years

Central Contacts

Madette Galapin

CONTACT

(416) 480-6100 Madette.Galapin@sunnybrook.ca

Data from ClinicalTrials.gov

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