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Local Radiotherapy Following Complete Resection of a Brain Metastasis

17. Mai 2019 aktualisiert von: Anna Bruynzeel, Amsterdam UMC, location VUmc

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.

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.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

70

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Niederlande
      • Amsterdam, Niederlande, 1066CX
        • Netherlands Cancer Institute - Antoni van Leeuwenhoek
      • Amsterdam, Niederlande, 1081HV
        • VU University Medical Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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 0-2.
  • 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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: observation
Watchful waiting
Aktiver Komparator: local stereotactic radiotherapy (SRT)
local SRT in three fractions of 8 Gy to the surgical cavity
Strahlung: local SRT
local stereotactic radiotherapy in three fractions of 8 Gy to the surgical cavity
Andere Namen:
  • Stereotaktische Strahlentherapie
  • Radiochirurgie

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
local control rate
Zeitfenster: at 6 months
as assessed on follow-up MRI scans
at 6 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Decrease in neurocognitive test results using the Hopkins Verbal Learning Test Revised (HVLT-R), in full cohorts
Zeitfenster: baseline, at 3 months, 6 months and 12 months
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.
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
Zeitfenster: baseline, at 3 months, 6 months and 12 months
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
baseline, at 3 months, 6 months and 12 months
Decrease in neurocognitive test results using the Controlled Oral Word Association (COWA), in full cohorts
Zeitfenster: baseline, at 3 months, 6 months and 12 months
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.
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
Zeitfenster: baseline, at 3 months, 6 months and 12 months

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.
baseline, at 3 months, 6 months and 12 months
Decrease in neurocognitive test results using the Grooved Pegboard, in full cohorts
Zeitfenster: baseline, at 3 months, 6 months and 12 months
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.
baseline, at 3 months, 6 months and 12 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Amsterdam UMC, location VUmc

Mitarbeiter

UMC Utrecht
The Netherlands Cancer Institute

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Mai 2015

Primärer Abschluss (Tatsächlich)

1. Mai 2017

Studienabschluss (Tatsächlich)

1. Mai 2017

Studienanmeldedaten

Zuerst eingereicht

19. Februar 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

31. März 2016

Zuerst gepostet (Schätzen)

6. April 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. Mai 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

17. Mai 2019

Zuletzt verifiziert

1. Mai 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • NL5128302914

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

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