Operation for Recurrent Glioblastoma
Zusammenfassung der Studie
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)
Untersuchte Intervention
Repeat surgery of the glioblastoma followed by second-line therapy (chemotherapy or radiotherapy)
(BASEC)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
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)
Studienstandort
Aarau, Basel, Bern, Genf, Lausanne, Lugano, Luzern, St Gallen, Zürich
(BASEC)
Sponsor
Philippe Schucht Insel Gruppe AG
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Philippe Schucht
+41 31 632 24 09
philippe.schucht@clutterinsel.chInsel Gruppe AG
(BASEC)
Allgemeine Auskünfte
Dep. of Neurosurgery, Inselspital Bern,
+41 31 66 4 28 65
philippe.schucht@clutterinsel.ch(ICTRP)
Wissenschaftliche Auskünfte
Dep. of Neurosurgery, Inselspital Bern,
+41 31 66 4 28 65
philippe.schucht@clutterinsel.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Bern
(BASEC)
Datum der Bewilligung durch die Ethikkommission
24.04.2015
(BASEC)
ICTRP Studien-ID
NCT02394626 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
RESURGE – Randomized Controlled Comparative Phase II Trial on Surgery for Glioblastoma Recurrence (BASEC)
Wissenschaftlicher Titel
RESURGE - Randomized Controlled Comparative Phase II Trial on Surgery for Glioblastoma Recurrence (ICTRP)
Öffentlicher Titel
Surgery for Recurrent Glioblastoma (ICTRP)
Untersuchte Krankheit(en)
Glioblastoma (ICTRP)
Untersuchte Intervention
Procedure: Surgery followed by adjuvant second-line therapy;Procedure: Second-line therapy alone (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
European Organisation for Research and Treatment of Cancer - EORTC (ICTRP)
Weitere Kontakte
Philippe Schucht, Prof. Dr. med.;Claire Descombes, claire.descombes@insel.ch, +41 31 66 4 28 65, Dep. of Neurosurgery, Inselspital Bern, (ICTRP)
Sekundäre IDs
368/14 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT02394626 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar