Brain NeoplasmsNCT02729558
Local Radiotherapy Following Complete Resection of a Brain Metastasis
A study testing local SRT in people with Brain Neoplasms, run by Amsterdam UMC, location VUmc at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Neoplasms
- What is being tested?
- local SRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesNetherlands
- Study dates
- May 2015to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 0-2.
- Ability to provide written informed consent.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Netherlands Cancer Institute - Antoni van Leeuwenhoek
Amsterdam, 1066CX
VU University medical center
Amsterdam, 1081HV
About this study
Official title: Postoperative Local Stereotactic Radiotherapy Versus Observation Following a Complete Resection of a Single Brain Metastasis
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.
Read more
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.
Read the 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.
- Conditions
- Brain Neoplasms
- Being tested
- local SRT
- Keywords
- brain metastases, radiotherapy, resection
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local SRTRadiation
Also called stereotactic radiotherapy, radiosurgery
local stereotactic radiotherapy in three fractions of 8 Gy to the surgical cavity
| Study group | Role | What they receive |
|---|---|---|
| observation | No intervention | Watchful waiting |
| local stereotactic radiotherapy (SRT) | Active comparator | local SRT in three fractions of 8 Gy to the surgical cavity Receives: Radiation: local SRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
local control rate
as assessed on follow-up MRI scans
Measured: at 6 months
Secondary outcomes (5)
Decrease in neurocognitive test results using the Hopkins Verbal Learning Test Revised (HVLT-R), in full cohorts
Neurocognitive testing will be performed at baseline, at three, six and twelve months follow-up using the Hopkins Verbal Learning Test Revised (HVLT-R). The HVLT-R is one of the components used to form the core set of cognitive tests recommended to use in oncology trials. This test measures immediate memory span, provides a learning curve, measures both short-term and longer-term retention, and allows for a comparison between retrieval efficiency and learning. This version includes 3 learning trials of a 12-word list, an interval of 20 minutes a delayed recall, and a recognition trial consisting of the target words interspersed with distractor words. The score on the recognition trial is the total number of correct response. This measure has adequate psychometric properties and 6 multiple forms.
Measured: baseline, at 3 months, 6 months and 12 months
Decrease in specified neurocognitive test results using the Trail Making A and B, in full cohorts
Neurocognitive testing will be performed at baseline, at three, six and twelve months follow-up using the Trail Making A and B. This test is one of the components used to form the core set of cognitive tests recommended to use in oncology trials. This is a test of visual conceptual and visuomotor tracking. It measures psychomotor speed and aspects of executive function. It is given in two parts, A and B. The subject must first draw lines to connect consecutively numbered circles on one work sheet (part A) and then connect the same number of consecutively numbered and lettered circles on another worksheet by alternating between the two sequences (part B). The subject is urged to connect the circles as fast as possible
Measured: baseline, at 3 months, 6 months and 12 months
Decrease in neurocognitive test results using the Controlled Oral Word Association (COWA), in full cohorts
Neurocognitive testing will be performed at baseline, at three, six and twelve months follow-up using the Controlled Oral Word Association (COWA). The COWA is one of the components used to form the core set of cognitive tests recommended to use in oncology trials. This test measures speeded verbal fluency and aspects of executive function. In this test, subjects are asked to generate as many words as possible in 1 minute beginning with "B", "D," and "H". It has two forms.
Measured: 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
Neurocognitive testing will be performed at baseline, at three, six and twelve months follow-up using the WAIS III Digit Span and WAIS III Digit Symbol. These added cognitive tests are also chosen based on their proven sensitivity to measure change in neuro-oncology patients. The subtest of the WAIS-III (Digit Span) involves forward and backward repetitions of series of digits and provides measures of concentration. This measure has adequate psychometric properties.
The subtest of the WAIS III (Digit Symbol) involves a symbol substitution task that requires visual-motor coordination, motor persistence, and sustained attention. The test is used as a test for information processing speed. The task consists of pairing numbers to nonsense symbols as quickly as possible.
Measured: baseline, at 3 months, 6 months and 12 months
Decrease in neurocognitive test results using the Grooved Pegboard, in full cohorts
Neurocognitive testing will be performed at baseline, at three, six and twelve months follow-up using the Grooved Pegboard. This added cognitive test is also chosen based on its proven sensitivity to measure change in neuro-oncology patients. This test measures motor speed and dexterity and is an adjusted version of the Purdue Pegboard test. The test consists out of plywood with 2 columns of 30 holes and a zinced bowl filled with metal pegs above each column. Subjects are offered one minute to put as many pegs as possible into the holes. The test has two different trials: dominant hand only and non-dominant hand only.
Measured: baseline, at 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startMay 2015
- Primary completionMay 2017
- Study completionMay 2017
Why it stopped: Too limited accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- The Netherlands Cancer Institute, UMC Utrecht
- Responsible party
- Principal investigator, Anna Bruynzeel, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729558
- Sponsor's protocol ID
- NL5128302914
- Status last verified
- May 2019
- First submitted
- 19 Feb 2016
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Local Stereotactic Radiotherapy Versus Observation Following a Complete Resection of a Single Brain Metastasis
- ClinicalTrials.gov ID
- NCT02729558
- Acronym / sponsor ID
- NL5128302914
- Conditions
- Brain Neoplasms
- Keywords
- brain metastases, radiotherapy, resection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too limited accrual
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- The Netherlands Cancer Institute, UMC Utrecht
- Study start
- May 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| observation | No intervention | –Watchful waiting |
| local stereotactic radiotherapy (SRT) | Active comparator | Radiation: local SRTlocal SRT in three fractions of 8 Gy to the surgical cavity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 0-2.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| local SRTAlso: stereotactic radiotherapy, radiosurgerylocal stereotactic radiotherapy in three fractions of 8 Gy to the surgical cavity | Radiation | local stereotactic radiotherapy (SRT) |
Primary outcome
local control rate
Time frame: at 6 months
as assessed on follow-up MRI scans
5 secondary outcomes
Decrease in neurocognitive test results using the Hopkins Verbal Learning Test Revised (HVLT-R), in full cohorts
Time frame: baseline, at 3 months, 6 months and 12 months
Decrease in specified neurocognitive test results using the Trail Making A and B, in full cohorts
Time frame: baseline, at 3 months, 6 months and 12 months
Decrease in neurocognitive test results using the Controlled Oral Word Association (COWA), in full cohorts
Time frame: 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
Time frame: baseline, at 3 months, 6 months and 12 months
Decrease in neurocognitive test results using the Grooved Pegboard, in full cohorts
Time frame: baseline, at 3 months, 6 months and 12 months
Results and safety
The study was stopped early (reason given: Too limited accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing local SRT in people with Brain Neoplasms, run by Amsterdam UMC, location VUmc at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Too limited accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local control rate (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2019.