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Not yet recruiting NCT04809792

MR-Linac for Head and Neck SBRT

No phase Interventional Head and Neck Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SBRT on the MR-Linac.
Who it may be relevant to
Registry conditions: Head and Neck Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Proportion of patients who complete ≥80% of treatment fractions in ≤60 minutes. [Time frame: 2 years]
Secondary outcome measures (10)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT04809792 · 1509

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗