Operation for Recurrent Glioblastoma
Résumé de l'étude
Glioblastoma refers to a brain tumor. The standard therapy after initial diagnosis is the surgical removal of the main part of the tumor, as long as the tumor's location allows it. Subsequently, patients receive a combined chemotherapy and radiotherapy, which has been shown to improve prognosis. Despite intensive therapy, glioblastomas recur because tumor cells continue to grow into the surrounding brain. In this situation, two treatment concepts are available: both further surgery followed by second-line therapy (chemotherapy or radiotherapy) and direct second-line therapy (chemotherapy or radiotherapy) can help to reduce the glioblastoma. The impact of a repeat surgery on the prognosis is unclear. The operation can only reduce the visible part of the tumor, and there is a risk of complications. Furthermore, the time until chemotherapy or radiotherapy is delayed by the healing time after surgery. Some analyses show encouraging results after repeat surgery, while other analyses demonstrate the same treatment success for both treatment concepts. The purpose of this clinical study is to improve the treatment of recurrent glioblastoma by investigating whether one of the treatment concepts has greater success and which one that is.
(BASEC)
Intervention étudiée
Repeat surgery of the glioblastoma followed by second-line therapy (chemotherapy or radiotherapy)
(BASEC)
Maladie en cours d'investigation
Glioblastoma Multiforme (GBM)
(BASEC)
All individuals over 18 years of age in good physical condition can participate, provided that an initial recurrence of the brain tumor (glioblastoma) has been detected in the MRI (Magnetic Resonance Imaging). Additionally, the glioblastoma must have been surgically removed at initial diagnosis and treated with chemotherapy and/or radiotherapy. (BASEC)
Critères d'exclusion
Individuals for whom surgery is not possible for any reason or who have had the glioblastoma recur less than 3 months after the completion of radiotherapy are not allowed to participate. (BASEC)
Lieu de l’étude
Aarau, Bâle, Berne, Genève, Lausanne, Lugano, Luzern, St-Gall, Zurich
(BASEC)
Sponsor
Philippe Schucht Insel Gruppe AG
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Philippe Schucht
+41 31 632 24 09
philippe.schucht@clutterinsel.chInsel Gruppe AG
(BASEC)
Informations générales
Dep. of Neurosurgery, Inselspital Bern,
+41 31 66 4 28 65
philippe.schucht@clutterinsel.ch(ICTRP)
Informations scientifiques
Dep. of Neurosurgery, Inselspital Bern,
+41 31 66 4 28 65
philippe.schucht@clutterinsel.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
24.04.2015
(BASEC)
Identifiant de l'essai ICTRP
NCT02394626 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
RESURGE – Randomized Controlled Comparative Phase II Trial on Surgery for Glioblastoma Recurrence (BASEC)
Titre académique
RESURGE - Randomized Controlled Comparative Phase II Trial on Surgery for Glioblastoma Recurrence (ICTRP)
Titre public
Surgery for Recurrent Glioblastoma (ICTRP)
Maladie en cours d'investigation
Glioblastoma (ICTRP)
Intervention étudiée
Procedure: Surgery followed by adjuvant second-line therapy;Procedure: Second-line therapy alone (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Written informed consent
- =18 years of age
- Prior resection of glioblastoma confirmed by histology
- Glioblastoma pretreated with standard radiotherapy without or with temozolomide
- First progression according to RANO criteria
- First progression not within 3 months after completion of radiation therapy
- Complete removal of contrast-enhancing lesion considered feasible without
significant risk of permanent speech or motor function according to MRI as confirmed
by study eligibility committee after screening and prior to recruitment
- No encroachment of the M1 or A1 segments of the medial and anterior cerebral artery
on MRI
- No contrast enhancement in presumed speech and primary motor areas on MRI
- No midline shift on MRI
- No contrast enhancing ventricular spread, multifocal recurrence, meningeosis
carcinomatosa or infiltration of the contra-lateral hemisphere on MRI
- No contra-indication for surgery
- Good functional status (KPS = 70)
Exclusion Criteria (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Overall survival from the date of inclusion (ICTRP)
Recruitment rate for all screened patients;Progression-free survival;Morbidity of surgery;Total number of days spent at home after recurrence;Total number of days spent outside home after recurrence (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
European Organisation for Research and Treatment of Cancer - EORTC (ICTRP)
Contacts supplémentaires
Philippe Schucht, Prof. Dr. med.;Claire Descombes, claire.descombes@insel.ch, +41 31 66 4 28 65, Dep. of Neurosurgery, Inselspital Bern, (ICTRP)
ID secondaires
368/14 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT02394626 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible