MR-Linac for Head and Neck SBRT
Primary Purpose
Head and Neck Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SBRT on the MR-Linac
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring Adaptive radiotherapy
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Head and neck cancer
Arm Description
In this arm patients with head and neck cancers treated with SBRT are recruited.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Quality of Life as measured by the MD Anderson Symptom Inventory - Head and Neck (MDASI-HN)
Patient Reported Outcome (PRO) measure of symptoms
Quality of Life as measured by the MD Anderson Dysphagia Inventory (MDADI)
Patient Reported Outcome (PRO) measure of symptoms
Quality of Life as measured by the Xerostomia Questionnaire (XQ)
Patient Reported Outcome (PRO) measure of symptoms
Quality of Life as measured by the Patient experience Questionnaire for MR-Linac
Patient Reported Outcome (PRO) measure of symptoms
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
Progression-free survival
Calculated as time from diagnosis to either death or detection of recurrent disease
Overall survival
Calculated as time from diagnosis to either death or last follow-up
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
Full Information
NCT ID
NCT04809792
First Posted
March 15, 2021
Last Updated
May 19, 2023
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT04809792
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Adaptive radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Head and neck cancer
Arm Type
Experimental
Arm Description
In this arm patients with head and neck cancers treated with SBRT are recruited.
Intervention Type
Radiation
Intervention Name(s)
SBRT on the MR-Linac
Intervention Description
Radiotherapy is performed on the 1.5 T MR Linac
Primary Outcome Measure Information:
Title
Proportion of patients who complete ≥80% of treatment fractions in ≤60 minutes.
Description
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 Outcome Measure Information:
Title
Dosimetric outcomes in HN SBRT patients treated with MR-guided adaptation as compared to non-adaptive HN SBRT.
Description
Prospectively recorded OAR dose, cumulative GTV/PTV dose, and projected dose that would have been delivered by non-adaptive plans.
Time Frame
2 years
Title
Number of participants with Acute and Late Toxicity
Description
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
Title
Quality of Life as measured by the MD Anderson Symptom Inventory - Head and Neck (MDASI-HN)
Description
Patient Reported Outcome (PRO) measure of symptoms
Time Frame
2 years
Title
Quality of Life as measured by the MD Anderson Dysphagia Inventory (MDADI)
Description
Patient Reported Outcome (PRO) measure of symptoms
Time Frame
2 years
Title
Quality of Life as measured by the Xerostomia Questionnaire (XQ)
Description
Patient Reported Outcome (PRO) measure of symptoms
Time Frame
2 years
Title
Quality of Life as measured by the Patient experience Questionnaire for MR-Linac
Description
Patient Reported Outcome (PRO) measure of symptoms
Time Frame
2 years
Title
Locoregional control 6 months based on RECIST criteria 1.1 and assessed on MRI or CT scan imaging
Description
Calculated from time of treatment completion to disease progression at primary site or regional lymph nodes
Time Frame
6 months
Title
Progression-free survival
Description
Calculated as time from diagnosis to either death or detection of recurrent disease
Time Frame
2 years
Title
Overall survival
Description
Calculated as time from diagnosis to either death or last follow-up
Time Frame
2 years
Title
Changes in tumor apparent diffusion coefficient (ADC) maps from diffusion weighted (DWI) MRI scan at baseline and at each fraction
Description
Functional imaging kinetics as a correlate of treatment response
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Madette Galapin
Phone
(416) 480-6100
Ext
89638
Email
Madette.Galapin@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene Karam
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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MR-Linac for Head and Neck SBRT
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