MR-Linac for Head and Neck SBRT

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04809792
• Other study ID #: 1509
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: June 1, 2030

Study information

• Verified date: May 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: Madette Galapin
• Phone: (416) 480-6100
• Email: Madette.Galapin[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 1, 2030
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Radiation:
• SBRT on the MR-Linac
Radiotherapy is performed on the 1.5 T MR Linac

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Quality of Life as measured by the MD Anderson Dysphagia Inventory (MDADI)	Patient Reported Outcome (PRO) measure of symptoms	2 years
Secondary	Quality of Life as measured by the Xerostomia Questionnaire (XQ)	Patient Reported Outcome (PRO) measure of symptoms	2 years
Secondary	Quality of Life as measured by the Patient experience Questionnaire for MR-Linac	Patient Reported Outcome (PRO) measure of symptoms	2 years
Secondary	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
Secondary	Progression-free survival	Calculated as time from diagnosis to either death or detection of recurrent disease	2 years
Secondary	Overall survival	Calculated as time from diagnosis to either death or last follow-up	2 years
Secondary	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