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UNITy-BasED MR-Linac Adaptive Simultaneous Integrated Hypofractionated Boost Trial for High Grade Glioma in the Elderly

Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · Sep 28, 2022

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

ClinConnect Summary

The UNITy-BasED MR-Linac trial is studying a new approach to treating older patients with glioblastoma, a serious type of brain cancer. Currently, patients over 65 typically receive a lower dose of radiation over three weeks, combined with a chemotherapy drug called temozolomide. However, this standard treatment has not resulted in good survival rates. This trial aims to see if giving a higher dose of radiation, similar to what younger patients receive, could improve outcomes. By using advanced technology called MR-Linac, doctors can adjust treatment plans based on daily MRI scans, making the therapy more personalized and potentially more effective.

To participate in the trial, patients need to be at least 65 years old and have a confirmed diagnosis of glioblastoma or a related condition. They should be healthy enough to undergo 15 daily sessions of radiation over three weeks and be willing to complete some quality of life questionnaires. Participants can expect to receive a higher radiation dose than usual while being closely monitored for their health throughout the treatment. It’s important to note that certain medical conditions or previous treatments may make some patients ineligible, so discussing individual circumstances with a doctor is essential.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patient age ≥ 65 years
  • Histopathologically confirmed, based on biopsy or surgical resection, glioblastoma or WHO grade 4 astrocytoma, IDH-mutant
  • Biopsy or surgical resection performed ≤ 6 weeks prior to study entry
  • Deemed suitable by the treating physicians for 15 daily fractions of radiation, delivered daily over 3 weeks, with concurrent temozolomide chemotherapy
  • Expected survival ≥ 12 weeks
  • ECOG performance status of 0, 1 or 2
  • Able (sufficiently fluent in English) and willing to complete QOL questionnaires; however, inability to complete the questionnaires will not make the patient ineligible for the study
  • Sufficient estimated glomerular filtration rate (eGFR) of ≥ 30 mL/min/1.73 m2 to allow administration of gadolinium-based contrast agent; patients with eGFR \< 30 mL/min/1.73 m2 not on dialysis may be allowed on the study after discussion of risks and benefits and approval by study neuroradiologist(s)
  • Completed written informed consent
  • Patient must be accessible for treatment and follow-up
  • Exclusion Criteria:
  • Contraindications to MRI as per standard MRI screening policy
  • Contraindication to Gadolinium-based contrast media
  • Inability to lie flat in a supine position for at least 90 minutes
  • Inability to tolerate immobilization in a head thermoplastic mask
  • Patients \> 140 kg and/or a circumference \> 60 cm
  • Prior dose-limiting cranial irradiation
  • T1w post-gadolinium enhancing disease involving the brainstem
  • Leptomeningeal dissemination of disease
  • Patients with any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol

About Sunnybrook Health Sciences Centre

Sunnybrook Health Sciences Centre is a leading academic health science organization located in Toronto, Canada, renowned for its commitment to advancing patient care through innovative research and education. As a prominent clinical trial sponsor, Sunnybrook integrates cutting-edge medical research with clinical practice, focusing on a wide range of health disciplines, including cancer care, trauma, and cardiovascular health. The center collaborates with various stakeholders, including academic institutions, healthcare providers, and industry partners, to facilitate the development of novel therapies and improve health outcomes. With a robust infrastructure and a dedicated team of researchers and clinicians, Sunnybrook plays a pivotal role in translating scientific advancements into tangible benefits for patients.

Locations

Toronto, Ontario, Canada

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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