- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00904553
Study of Resection Combined With Stereotactic Radiosurgery for 1 to 3 Brain Metastases
Pilot Study of Resection Combined With Stereotactic Radiosurgery in Patients With Limited (1-3) Brain Metastases
This study is to look more closely at the tumor removed during your surgery, and to follow your condition after your treatment.
The purpose of this study is to determine what side effects are common or more rare from this treatment, how well the treatment has worked for you, and to track whether you develop other brain metastases.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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New York
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Rochester, New York, États-Unis, 14642
- Department of Radiation Oncology, University of Rochester Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Patients must have a previously histopathologically proven diagnosis of malignancy.
- Patients must be evaluated by Neurosurgery and Radiation Oncology
- Patients must have 1-3 brain metastases seen on MRI or CT imaging. At least one brain metastases must be considered resectable by craniotomy as determined by the treating neurosurgeon. Brain lesion resection must be considered standard of care. A not uncommon situation is for a patient to undergo resection of a solitary metastasis, but prove to have more lesions on subsequent MRIs (perhaps too small to be seen on a pre-operative MRI). These patients will be eligible if the total number of lesions is 1-3.
- All lesions must be treatable by SRS as determined by the treating neurosurgeon and radiation oncologist.
- All lesions must be <4 cm in greatest dimension. For patients with more than 1 brain metastases, only 1 lesion can exceed 3 cm in greatest dimension.
- In patients treated to the post-op surgical cavity, this cavity must be encompassed by a CTV of <5 cm.
- Patients must have a Karnofsky performance status ≥60.
- Extracranial disease must not be considered imminently life threatening (<2 month anticipated survival from extracranial disease).
- Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Exclusion Criteria:
- KPS<60
- life expectancy > 2 months
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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Novalis Shaped Beam Surgery
Patients with limited brain metastases (mostly solitary brain metastasis) treated with Novalis Shaped Beam Surgery followed by planned craniotomy and resection of the metastases.
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Treatment using Novalis SRS
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Determine toxicity of treatment with cranial SRS and resection
Délai: During treatment and long term follow-up
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During treatment and long term follow-up
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Determine the local control of the treated lesion(s), distant brain control and overall patient survival.
Délai: During treatment and long term follow-up
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During treatment and long term follow-up
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Tissue from the resected brain metastases will be evaluated with immunohistochemistry and/or comparative genomic hybridization to assess for potential markers for clinical outcome as well as potential markers of radiation response.
Délai: Following surgical resection
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Following surgical resection
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Michael Milano, MD PhD, Department of Radiation Oncology, University of Rochester Medical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- URBT07099
- RSRB00023405 (Autre identifiant: Univ of Rochester IRB)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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 .