NCT02729558

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 20, 2019

Status Verified

May 1, 2019

Enrollment Period

2 years

First QC Date

February 19, 2016

Last Update Submit

May 17, 2019

Conditions

Brain Neoplasms

Keywords

brain metastasesradiotherapyresection

Outcome Measures

Primary Outcomes (1)

  • local control rate

    as assessed on follow-up MRI scans

    at 6 months

Secondary Outcomes (5)

  • 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 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 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

  • Decrease in neurocognitive test results using the Grooved Pegboard, in full cohorts

    baseline, at 3 months, 6 months and 12 months

Study Arms (2)

observation

NO INTERVENTION

Watchful waiting

local stereotactic radiotherapy (SRT)

ACTIVE COMPARATOR

local SRT in three fractions of 8 Gy to the surgical cavity

Radiation: local SRT

Interventions

local SRTRADIATION

local stereotactic radiotherapy in three fractions of 8 Gy to the surgical cavity

Also known as: stereotactic radiotherapy, radiosurgery
local stereotactic radiotherapy (SRT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Netherlands Cancer Institute - Antoni van Leeuwenhoek

Amsterdam, 1066CX, Netherlands

Location

VU University medical center

Amsterdam, 1081HV, Netherlands

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD Radiation Oncologist

Study Record Dates

First Submitted

February 19, 2016

First Posted

April 6, 2016

Study Start

May 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 20, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)