Clinical trial NCT04809792: MR-Linac for Head and Neck SBRT
Official title: Magnetic Resonance Imaging-Guided Radiotherapy for Head & Neck SBRT on the 1.5T MR-Linac
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Adaptive radiotherapy
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who complete ≥80% of treatment fractions in ≤60 minutes.
timeFrame: 2 years
Secondary outcomes:
measure: Dosimetric outcomes in HN SBRT patients treated with MR-guided adaptation as compared to non-adaptive HN SBRT.
timeFrame: 2 years
measure: Number of participants with Acute and Late Toxicity
timeFrame: 2 years
measure: Quality of Life as measured by the MD Anderson Symptom Inventory - Head and Neck (MDASI-HN)
timeFrame: 2 years
measure: Quality of Life as measured by the MD Anderson Dysphagia Inventory (MDADI)
timeFrame: 2 years
measure: Quality of Life as measured by the Xerostomia Questionnaire (XQ)
timeFrame: 2 years
measure: Quality of Life as measured by the Patient experience Questionnaire for MR-Linac
timeFrame: 2 years
measure: Locoregional control 6 months based on RECIST criteria 1.1 and assessed on MRI or CT scan imaging
timeFrame: 6 months
measure: Progression-free survival
timeFrame: 2 years
measure: Overall survival
timeFrame: 2 years
measure: Changes in tumor apparent diffusion coefficient (ADC) maps from diffusion weighted (DWI) MRI scan at baseline and at each fraction
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Irene Karam
role: PRINCIPAL_INVESTIGATOR
References: