search
Back to results

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
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Adaptive radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    March 15, 2021
    Last Updated
    May 19, 2023
    Sponsor
    Sunnybrook Health Sciences Centre
    search

    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

    Learn more about this trial

    MR-Linac for Head and Neck SBRT

    We'll reach out to this number within 24 hrs