MR-Linac for Head and Neck SBRT

NCT04809792 | Not Yet Recruiting

• 1 other identifier: 1509
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Head and Neck Cancer

Keywords

Adaptive radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (10)

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

  2 years

• Number of participants with Acute and Late Toxicity

  2 years

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

  2 years

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

  2 years

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

  2 years

Study Arms (1)

Head and neck cancer

EXPERIMENTAL

In this arm patients with head and neck cancers treated with SBRT are recruited.

Radiation: SBRT on the MR-Linac

Interventions

SBRT on the MR-Linac RADIATION

Radiotherapy is performed on the 1.5 T MR Linac

Head and neck cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Irene Karam

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madette Galapin

CONTACT

(416) 480-6100; Madette.Galapin@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 22, 2021
• Study Start: June 1, 2023
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2030
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share