Neoplasms

Symptoms and General Pathology

All Conditions

Nervous System Diseases

Neoplasm Metastasis

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Stereotactic radiosurgery plus whole brain radiation

SRS or hypofractionated stereotactic radiation delivered via the Leksell Gammknife Perfexion/Icon radiosurgery system. Hypofractionated stereotactic radiotherapy 25-32.5 Gy in 5 fractions or 24-27 Gy in 3 fractions at the discretion of the radiation oncologist

Maximum diameter of metastasis (doses in single fraction):

≤ 2 cm: 15-20 Gy \> 2 cm and ≤ 3 cm: 15-18 Gy \> 3 cm and ≤ 4 cm: 15 Gy

Tumour location (doses in single fraction):

Brainstem: 15 Gy

Hypofractionated stereotactic radiotherapy 25-32.5 Gy in 5 fractions may be used for lesions \> 2 cm at the discretion of the radiation oncologist

Note: SRS dosing reduced by 20% (for all prescriptions \> 15 Gy) when patient is randomized to SRS + WBRT arm

Stereotactic Radiosurgery (SRS)

WBRT 20 Gy in 5 fractions or 30 Gy in 10 fractions at the discretion of the radiation oncologist

Whole brain radiation (WBRT)

Diana Ristevski

Diana Ristevski, BSc

Chia-Lin (Eric) Tseng, MD

Chia-Lin Tseng, M.D.

This clinical study is a parallel, prospective observational single-centre trial in patients presenting with 5 to 30 brain metastases. Patients to receive either stereotactic radiosurgery (SRS) alone or SRS plus whole brain radiation (WBRT) will be enrolled.

The current standard of care for patients with limited brain metastases (1 to 4) is stereotactic radiosurgery (SRS) alone. This has evolved from the traditional standard of care in treating patients with whole brain radiation (WBRT). Studies in patients with limited (less than 5) brain metastases have shown that WBRT is harmful with respect to neurocognition and does not improve patient survival compared to SRS alone. As a result, SRS alone now is considered the standard of care treatment for patients with limited metastases. However, there is a lack of high quality prospective randomized evidence on the role of SRS in patients with 5 or more brain metastases to guide treatment.

Therefore, this study seeks to prospectively compare SRS alone versus SRS plus WBRT in patients with 5 to 30 brain metastases.

Radiosurgery With or Without Whole Brain Radiation for Multiple Metastases

Parallel Prospective Observational Cohorts Evaluating Stereotactic Radiosurgery Alone (SRS) and Whole Brain Radiotherapy (WBRT) Plus SRS for Patients With 5 to 30 Brain Metastases

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall using the Reliable Change Index (RCI)

Hopkins Verbal Learning Test-Revised (HVLT-R) (Total Recall, Delayed Recall, Delayed Recognition)

Trail Making Test (TMT, Part A and Part B)

Clinical Trial Battery Composite (CTB COMP) score

Defined by the response criteria stipulated in the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria guideline

Distant brain failure is defined as the appearance of one or more new lesions on a diagnostic-quality, contrast-enhanced MRI within the brain at sites other than those initially treated by SRS

Response will be recorded for each individual target lesion and for overall central nervous system (CNS) response as a composite of radiographical CNS target and non-target lesion responses, corticosteroid use, and clinical status defined as per RANO-BM criteria

Health-Related QoL as measured by Functional Assessment of Cancer Therapy - Brain (FACT-Br) instrument

Number/proportion of patients requiring salvage therapy and type of salvage therapy, for progressive intracranial disease during follow-up

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radiosurgery With or Without Whole Brain Radiation for Multiple Metastases	NCT03775330	Brain Metastase...	Stereotactic Ra... Whole brain rad...	18 Years -	Sunnybrook Health Sciences Centre
Radiosurgery With or Without Whole Brain Radiation for Multiple Metastases	NCT03775330	Brain Metastase...	Stereotactic Ra... Whole brain rad...	18 Years -	Sunnybrook Health Sciences Centre
Radiosurgery With or Without Whole Brain Radiation for Multiple Metastases	NCT03775330	Brain Metastase...	Stereotactic Ra... Whole brain rad...	18 Years -	Sunnybrook Health Sciences Centre

Spots Global Cancer Trial Database for whole brain radiation (wbrt)