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Closed (no longer recruiting)Last updated: 14 December 2023

SHRINC: This phase II trial is assessing a type of radiotherapy treatment for patients whose cancer has spread to the brainA Phase II Prospective Trial of Stereotactic Hypofractionated Radiation for Multiple (3-10) cerebral metastases including Neurological and Cognitive assessment

Clinical summary

Summary

The purpose of this study is to investigate whether improved radiation planning technology that conforms to the shape and size of the cancer, can be used to treat multiple sites of cancer within the brain, and at the same time protect and preserve your brain (memory and cognitive) function. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with 3-10 measurable cerebral metastases, i.e. your cancer has spread to three or more spots on the brain. Study details: All participants in this study will receive a new treatment called Hypofractionated Stereotactic Radiotherapy. This is highly focused radiation given in one or a few (5-6) treatments. Robotic targeting is used to avoid important parts of the normal brain. Where previous treatment for multiple sites of cancer within the brain has involved giving radiation to the whole brain, this treatment will allow us to treat multiple areas at the same time. The aim is to avoid the use of whole brain radiation that can affect the memory structures within the brain such as the hippocampus, thus preserving brain (memory and cognitive) function. The trial will use software called "BrainLab Elements (Trademark)". This software will help the radiation oncologist to plan and deliver the radiotherapy treatment. All participants will be monitored throughout treatment for safety. They will also be asked to undergo MRI scans and complete some questionnaires at the start of the study and at 3 and 6 months after treatment to assess neurocognitive functioning, disease response, and quality of life. We estimate that this study will contribute further to the research into using radiotherapy to control cancers that have spread to the brain, while minimising the effects on brain function.

Conditions

This trial is treating patients with advanced cancer that has spread to the brain.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

II

Trial Acronym

SHRINC

More information

Trial Identifiers

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Trial sponsor

Intergrated Clinical Oncology Network Pty Ltd (ICON)

Scientific Title

A Phase II Prospective Trial of Stereotactic Hypofractionated Radiation for Multiple (3-10) cerebral metastases including Neurological and Cognitive assessment

Eligibility

Inclusion

  • • Pathological evidence of a known non-haematological malignancy within 5 years of enrolment.
    • Three to ten metastatic brain lesions or surgical cavities which correlate with the confirmed non-haematological malignancy.
    • Total Planning Target Volume <15cc for single or three fraction treatment and <35cc for fractionated treatment (five fractions).
    • Largest single Planning Target Volume of unresected disease <10cc
    • Largest single Planning Target Volume of a resection cavity <15 cc
    • Age >18years
    • Participants 60 years of age or older must nominate a friend or relative whom will participate in the cognitive decline questionnaire sub-study.
    • Must be sufficiently proficient in English to complete neuropsychology tests

Exclusion

 

• Cognitive impairment which may interfere with ability to participate in the neurocognitive assessments
• Untreated clinically significant hydrocephalus
• Haematological, Small cell, Germ Cell malignancy or unknown primary tumour
• Leptomeningeal disease
• Multiple new cranial nerve deficits in the absence of overt intracranial disease
• Prior cranial irradiation which would compromise safety if overlapped with protocol treatment
• Contra-indication for MRI and gadolinium contrast use:
o Participants with a known risk of poor renal function must have an estimated Glomerular Filtration Rate >50 millilitres per minute
o Known hypersensitivity to Gadolinium contrast
o Non-MRI compatible VP shunt/surgical apparatus
o Pacemaker/cardiac defibrillator not MRI compatible
• Contra-indications to steroid support (e.g. active peptic ulceration or previous steroid psychosis)

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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