Postoperative Local Stereotactic Radiotherapy Versus Observation Following a Complete Resection of a Single Brain Metastasis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 70
- Locations
- 4
- Primary Endpoint
- local control rate
Study Overview
Brief Summary
Objective: To improve local control following complete resection of a single brain metastasis using fractionated local stereotactic radiotherapy, whilst maintaining neurological functioning, neurocognition and quality of life.
Study design: Multicenter randomized phase III, with at least three high-volume Dutch centers participating in the trial. Stratification on primary tumor type and age.
Study population: Patients undergoing complete resection of a single brain metastasis, confirmed by an early (i.e. within 72 hours) postoperative contrast-enhanced MR scan.
Study intervention: Patients will be randomized between observation alone (standard arm) and local stereotactic radiotherapy in three fractions of 8 Gy to the surgical cavity (study arm).
Main study parameters: Primary objective: local control rate at 6 months. Secondary objectives: local control rate at 12 months, neurological functioning, freedom from clinical neurological progression, performance status, quality of life, toxicity, steroid use, neurocognition and overall survival.
Detailed Description
The objective of this study is to improve local control following complete resection of a single brain metastasis of solid tumors using fractionated local stereotactic radiotherapy, whilst maintaining neurological functioning, neurocognition and quality of life. The study is performed in the form of a multicenter randomized phase III, with at least three high-volume Dutch centers participating in the trial. Stratification will be performed on primary tumor type and age. A total of 70 patients will be included. Inclusion is restricted to patients who underwent a complete resection of a single brain metastasis, confirmed by an early (i.e. within 72 hours) postoperative contrast-enhanced magnetic resonance (MR) scan. Patients will be randomized between observation alone (standard arm) and local stereotactic radiotherapy in three fractions of 8 Gy to the surgical cavity (study arm).The main study parameters are: local control rate at 6 months (primary outcome measure) and local control rate at 12 months, neurological functioning, freedom from clinical neurological progression, performance status, quality of life, toxicity, steroid use, neurocognition and overall survival (secondary outcome measures). Follow up will be performed at three-monthly interval during the first two years, including MRI scans. Quality of life questionaires and neurocognitive functioning tests will be performed at fixed intervals during follow-up.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age of 18 years or older.
- •Radiologically confirmed complete resection of a single brain metastasis on a contrast-enhanced MRI within 72 h after resection.
- •Primary solid tumor, excluding hematologic malignancy, germ cell tumor, small cell lung cancer.
- •Stable extracranial tumor (primary tumor and/or systemic metastases) during the last three months with or without treatment or progressive extracranial tumor and/or systemic metastases for which effective treatment is available.
- •World Health Organization (WHO) performance score 0-
- •Ability to provide written informed consent.
Exclusion Criteria
- •Prior treatment for brain metastases (i.e. surgery, stereotactic radiotherapy or WBRT).
- •Distant brain metastases or radiological findings on MRI suspected for leptomeningeal tumor spread on the postoperative MRI.
- •Concurrent use of systemic therapy during local stereotactic radiotherapy
Arms & Interventions
observation
Watchful waiting
local stereotactic radiotherapy (SRT)
local SRT in three fractions of 8 Gy to the surgical cavity
Intervention: local SRT (Radiation)
Outcomes
Primary Outcomes
local control rate
Time Frame: at 6 months
as assessed on follow-up MRI scans
Secondary Outcomes
- Decrease in specified neurocognitive test results using the Trail Making A and B, in full cohorts(baseline, at 3 months, 6 months and 12 months)
- Decrease in neurocognitive test results using the Grooved Pegboard, in full cohorts(baseline, at 3 months, 6 months and 12 months)
- Decrease in neurocognitive test results using the Hopkins Verbal Learning Test Revised (HVLT-R), in full cohorts(baseline, at 3 months, 6 months and 12 months)
- Decrease in neurocognitive test results using the Controlled Oral Word Association (COWA), in full cohorts(baseline, at 3 months, 6 months and 12 months)
- Decrease in neurocognitive test results using using the Wechsler Adult Intelligence Scale (WAIS) III Digit Span and WAIS III Digit Symbol, in full cohorts(baseline, at 3 months, 6 months and 12 months)
Investigators
Anna Bruynzeel
MD PhD Radiation Oncologist
Amsterdam UMC, location VUmc