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Local Radiotherapy Following Complete Resection of a Brain Metastasis

17 mai 2019 mis à jour par: 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.

Aperçu de l'étude

Statut

Résilié

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

70

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: observation
Watchful waiting
Comparateur actif: local stereotactic radiotherapy (SRT)
local SRT in three fractions of 8 Gy to the surgical cavity
Radiation: local SRT
local stereotactic radiotherapy in three fractions of 8 Gy to the surgical cavity
Autres noms:
  • radiothérapie stéréotaxique
  • radiochirurgie

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
local control rate
Délai: at 6 months
as assessed on follow-up MRI scans
at 6 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Decrease in neurocognitive test results using the Hopkins Verbal Learning Test Revised (HVLT-R), in full cohorts
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Amsterdam UMC, location VUmc

Collaborateurs

UMC Utrecht
The Netherlands Cancer Institute

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mai 2015

Achèvement primaire (Réel)

1 mai 2017

Achèvement de l'étude (Réel)

1 mai 2017

Dates d'inscription aux études

Première soumission

19 février 2016

Première soumission répondant aux critères de contrôle qualité

31 mars 2016

Première publication (Estimation)

6 avril 2016

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

20 mai 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 mai 2019

Dernière vérification

1 mai 2019

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NL5128302914

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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