Head and Neck CancerNCT04809792
MR-Linac for Head and Neck SBRT
A study testing SBRT on the MR-Linac in people with Head and Neck Cancer, run by Sunnybrook Health Sciences Centre.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- SBRT on the MR-Linac
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Magnetic Resonance Imaging-Guided Radiotherapy for Head & Neck SBRT on the 1.5T MR-Linac
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- SBRT on the MR-Linac
- Keywords
- Adaptive radiotherapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRT on the MR-LinacRadiation
Radiotherapy is performed on the 1.5 T MR Linac
| Study group | Role | What they receive |
|---|---|---|
| Head and neck cancer | Experimental | In this arm patients with head and neck cancers treated with SBRT are recruited. Receives: Radiation: SBRT on the MR-Linac |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (10)
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.
Measured: 2 years
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.
Measured: 2 years
Quality of Life as measured by the MD Anderson Symptom Inventory - Head and Neck (MDASI-HN)
Patient Reported Outcome (PRO) measure of symptoms
Measured: 2 years
Quality of Life as measured by the MD Anderson Dysphagia Inventory (MDADI)
Patient Reported Outcome (PRO) measure of symptoms
Measured: 2 years
Quality of Life as measured by the Xerostomia Questionnaire (XQ)
Patient Reported Outcome (PRO) measure of symptoms
Measured: 2 years
Quality of Life as measured by the Patient experience Questionnaire for MR-Linac
Patient Reported Outcome (PRO) measure of symptoms
Measured: 2 years
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
Measured: 6 months
Progression-free survival
Calculated as time from diagnosis to either death or detection of recurrent disease
Measured: 2 years
Overall survival
Calculated as time from diagnosis to either death or last follow-up
Measured: 2 years
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Irene Karam, Sunnybrook Health Sciences Centre
- Investigators
- Irene Karam, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809792
- Sponsor's protocol ID
- 1509
- Status last verified
- May 2023
- First submitted
- 15 Mar 2021
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging-Guided Radiotherapy for Head & Neck SBRT on the 1.5T MR-Linac
- ClinicalTrials.gov ID
- NCT04809792
- Acronym / sponsor ID
- 1509
- Conditions
- Head and Neck Cancer
- Keywords
- Adaptive radiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head and neck cancer | Experimental | Radiation: SBRT on the MR-LinacIn this arm patients with head and neck cancers treated with SBRT are recruited. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRT on the MR-LinacRadiotherapy is performed on the 1.5 T MR Linac | Radiation | Head and neck cancer |
Primary outcome
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.
10 secondary outcomes
Dosimetric outcomes in HN SBRT patients treated with MR-guided adaptation as compared to non-adaptive HN SBRT.
Time frame: 2 years
Number of participants with Acute and Late Toxicity
Time frame: 2 years
Quality of Life as measured by the MD Anderson Symptom Inventory - Head and Neck (MDASI-HN)
Time frame: 2 years
Quality of Life as measured by the MD Anderson Dysphagia Inventory (MDADI)
Time frame: 2 years
Quality of Life as measured by the Xerostomia Questionnaire (XQ)
Time frame: 2 years
Quality of Life as measured by the Patient experience Questionnaire for MR-Linac
Time frame: 2 years
Locoregional control 6 months based on RECIST criteria 1.1 and assessed on MRI or CT scan imaging
Time frame: 6 months
Progression-free survival
Time frame: 2 years
Overall survival
Time frame: 2 years
Changes in tumor apparent diffusion coefficient (ADC) maps from diffusion weighted (DWI) MRI scan at baseline and at each fraction
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Irene Karam principal investigator
Sunnybrook Health Sciences Centre
Questions about this trial
What is this clinical trial studying?
A study testing SBRT on the MR-Linac in people with Head and Neck Cancer, run by Sunnybrook Health Sciences Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madette Galapin ((416) 480-6100 ext. 89638, Madette.Galapin@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who complete ≥80% of treatment fractions in ≤60 minutes. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023; AzTrials last refreshed its copy on 31 Oct 2026.