Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT04809792

MR-Linac for Head and Neck SBRT

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SBRT on the MR-Linac

Radiation

Radiotherapy is performed on the 1.5 T MR Linac

Primary outcomes

  1. Proportion of patients who complete ≥80% of treatment fractions in ≤60 minutes.

    Time frame: 2 years

    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 outcomes

  1. Dosimetric outcomes in HN SBRT patients treated with MR-guided adaptation as compared to non-adaptive HN SBRT.

    Time frame: 2 years

    Prospectively recorded OAR dose, cumulative GTV/PTV dose, and projected dose that would have been delivered by non-adaptive plans.

  2. Number of participants with Acute and Late Toxicity

    Time frame: 2 years

    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.

  3. Quality of Life as measured by the MD Anderson Symptom Inventory - Head and Neck (MDASI-HN)

    Time frame: 2 years

    Patient Reported Outcome (PRO) measure of symptoms

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

    Time frame: 2 years

    Patient Reported Outcome (PRO) measure of symptoms

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

    Time frame: 2 years

    Patient Reported Outcome (PRO) measure of symptoms

  6. Quality of Life as measured by the Patient experience Questionnaire for MR-Linac

    Time frame: 2 years

    Patient Reported Outcome (PRO) measure of symptoms

  7. Locoregional control 6 months based on RECIST criteria 1.1 and assessed on MRI or CT scan imaging

    Time frame: 6 months

    Calculated from time of treatment completion to disease progression at primary site or regional lymph nodes

  8. Progression-free survival

    Time frame: 2 years

    Calculated as time from diagnosis to either death or detection of recurrent disease

  9. Overall survival

    Time frame: 2 years

    Calculated as time from diagnosis to either death or last follow-up

  10. Changes in tumor apparent diffusion coefficient (ADC) maps from diffusion weighted (DWI) MRI scan at baseline and at each fraction

    Time frame: 2 years

    Functional imaging kinetics as a correlate of treatment response

Study contacts

Contact information is provided by the study sponsor or research team.

Madette Galapin

CONTACT

[email protected]

(416) 480-6100 ext. 89638

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2030
First posted
Mar 22, 2021
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.