MR-Linac for Head and Neck SBRT

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Proportion of patients who complete ≥80% of treatment fractions in ≤60 minutes. [Срок оценки: 2 years]

Вторичные конечные точки (10)

• Dosimetric outcomes in HN SBRT patients treated with MR-guided adaptation as compared to non-adaptive HN SBRT. [Срок оценки: 2 years]
• Number of participants with Acute and Late Toxicity [Срок оценки: 2 years]
• Quality of Life as measured by the MD Anderson Symptom Inventory - Head and Neck (MDASI-HN) [Срок оценки: 2 years]
• Quality of Life as measured by the MD Anderson Dysphagia Inventory (MDADI) [Срок оценки: 2 years]
• Quality of Life as measured by the Xerostomia Questionnaire (XQ) [Срок оценки: 2 years]
• Quality of Life as measured by the Patient experience Questionnaire for MR-Linac [Срок оценки: 2 years]
• Locoregional control 6 months based on RECIST criteria 1.1 and assessed on MRI or CT scan imaging [Срок оценки: 6 months]
• Progression-free survival [Срок оценки: 2 years]
• Overall survival [Срок оценки: 2 years]
• Changes in tumor apparent diffusion coefficient (ADC) maps from diffusion weighted (DWI) MRI scan at baseline and at each fraction [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT04809792 · 1509

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗