Clinical Trials on Neuro-Oncology
CCCV-Trial
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Title in German |
Die Auswirkung einer Erhöhung des elektrischen Stimulationsstroms oder der Pulsdauer auf die Patientenbewegung und die Amplitude der Überwachungssignale während einer Operation unter Funktionsüberwachung (CCCV-Studie) |
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Title in English |
The effect of increasing transcranial electric stimulation current or pulse duration on intraoperative patient movement and motor evoked potential amplitude |
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Description |
Bei dieser Studie wird ein Medizinprodukt (IOM-Gerät, IOM = Intraoperatives Neuromonitoring, vereinfacht: Funktionsüberwachung während der Operation) angewendet, welches für diesen Einsatz zertifiziert ist und bereits seit mehreren Jahren erfolgreich angewendet wird. |
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Wir vergleichen die Auswirkungen verschiedener Stimulationsparameter. Spezifisch werden verschiedene Kombinationen von Stromstärke und Pulsdauer getestet, um herauszufinden, welche davon eine minimale Bewegung der Patientin/des Patienten verursacht und so die Operateurin/den Operateur am wenigsten beeinträchtigt. |
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Während einer Operation am Gehirn ist es wichtig, millimetergenau zu agieren und somit sollte jede unnötige Bewegung der Patientin/des Patienten verhindert werden. |
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Phase |
II |
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Head Clinical Trial |
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Study Coordinator |
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Back-up |
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Status |
active since 10.08.2022 |
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BASEC-Nummer |
2022-D0047 |
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Nummer aus Studienregister (z.B. clinicaltrials.gov) |
NCT05375669 |
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WHO-Register-Nummer |
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Insel-Nummer |
5204 |
ETOP 19-21 USZ-STRIKE
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Title in German |
ETOP 19-21 USZ-STRIKE |
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Title in English |
ETOP 19-21 USZ-STRIKE |
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Description |
Immunotherapy or targeted therapy with or without stereotactic radiosurgery in patients with brain metastases from melanoma or non-small cell lung cancer. |
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Phase |
III |
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Head Clinical Trial |
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Study Coordinator |
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Back-up |
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Status |
aktive |
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BASEC-Nummer |
2022-01064 |
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Nummer aus Studienregister (z.B. clinicaltrials.gov) |
NCT05522660 |
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WHO-Register-Nummer |
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Insel-Nummer |
5406 |
PH-L19TNFCCNU-02/20
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Title in German |
Eine Studie zur Beurteilung der Sicherheit und Wirksamkeit des tumorspezifischen humanen monoklonalen Antikörper-Zytokin Fusionsproteins L19TNF plus Lomustin bei Patienten mit Glioblastom beim ersten Fortschreiten der Krankheit |
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Title in English |
A study to evaluate the safety and efficacy of the tumor-targeting human antibody-cytokine fusion protein L19TNF plus lomustine in patients with glioblastoma at first progression |
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Phase |
II |
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Description |
We want to investigate what the optimal dose of L19TNF is in combination with lomustine, how well the drug is tolerated in glioblastoma and whether the combination therapy improves survival rates. L19TNF is a new investigational compound with potential anticancer activity. This drug is comparable to the cancer drug TNF (BeromunTM). Unfortunately, the systemic use of TNF is associated with numerous side effects, including a (severe) dose-dependent hypotensive effect, which can sometimes lead to cardiac and pulmonary dysfunction. In this study, however, TNF is linked to the substance L19, which directs TNF directly to the tumor. In this way, a higher concentration of TNF in the tumor should be achieved and thus a reduction in side effects with the same effectiveness. L19TNF is an unapproved drug. |
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Head Clinical Trial |
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Study-Nurse |
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Back-up |
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Status |
open for patient recruitment: 09.10.2023 |
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BASEC Nummer |
2020_02413 |
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Insel-Nummer |
5288 |
PREOP-2
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Title in German |
Eine multizentrische prospektive, interventionelle, randomisierte Studie zur präoperativen Radiochirurgie im Vergleich zur postoperativen stereotaktischen Strahlentherapie bei resektablen Hirnmetastasen. |
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Title in English |
A multicentre prospective, interventional, randomised trial of preoperative radiosurgery compared with postoperative stereotactic radiotherapy for resectable brain metastases. |
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Description |
For brain metastases (offshoots of cancer in the brain) when they reach a certain size, different treatments are used. Currently, at the Inselspital Bern, the metastasis is first operated on and then (post-operatively) the region in which the metastasis was located (so-called “tumor bed”) is irradiated for 5 days. In some other clinics the opposite approach is also carried out, i.e. a single radiation treatment is carried out before the operation (so-called pre-operative). In our research project, we want to find out whether the return of metastases (recurrences) from the tumor bed is equally common in both forms of treatment and how patients experience the therapies (quality of life). |
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Phase/Biobank/etc. |
III |
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Head Clinical Trial |
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Study-Nurse |
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Back-up |
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Status |
active since 02.06.2022 |
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BASEC-Nummer |
2021-02094 |
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Nummer aus Studienregister |
Clinicaltrials.gov: NCT 05124236 |
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Insel-Nummer |
5139 |
Resdex-Studie
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Title in German |
Studie zur Implementierung eines restriktiven Dexamethason Behandlungsregimes in Hirntumor-Patienten |
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Title in English |
Restrictive Use of Dexamethasone in Glioblastoma |
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Description |
Ziel der Studie ist es zu untersuchen, ob die neurochirurgische Behandlung von Hirntumoren bei bestimmten Patienten ohne zusätzliche Verabreichung von Dexamethason (Kortison) oder nur einem Minimum (Dexamethason) durchgeführt werden kann. |
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Phase/Biobank/etc. |
Phase II |
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Head Clinical Trial |
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Study-Nurse |
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Back-up |
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Status |
active since 08.05.2020 |
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BASEC-Nummer |
2020-00286 |
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KOFAM |
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WHO-Register-Nummer |
NCT04266977 |
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Insel-Nummer |
4381 |
RESURGE
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Title in German |
RESURGE – Randomisierte kontrollierte komparative Phase-II-Studie zur Chirurgie bei Glioblastom Rezidiv. |
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Title in English |
RESURGE – Randomized Controlled Comparative Phase II Trial on Surgery for Glioblastoma Recurrence |
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Description |
To date, there are two established strategies to treat a recurrent brain tumor: |
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- Reoperation for the brain tumor, followed by second-line therapy (chemotherapy or radiotherapy) |
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- Immediate second-line therapy (chemotherapy or radiotherapy) without prior surgery. It is still unclear which of the two treatment strategies is more successful. The aim of this study is to investigate which of the two treatment strategies is more successful. |
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It is still unclear which of the two treatment strategies is more successful. The aim of this study is to investigate which of the two treatment strategies is more successful. |
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Phase/Biobank/etc. |
Phase II |
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Head Clinical Trial |
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Study-Nurse |
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Back-up |
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Status |
active since 2015 |
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BASEC-Nummer |
2016-1462 |
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KOFAM |
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WHO-Register-Nummer |
NCT02394626 |
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Insel-Nummer |
2752 |
Sonobird
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Title in German |
SonoCloud-9 in Kombination mit Carboplatin im Vergleich zu standardmässigen Chemotherapien (Lomustin oder Temozolomid) beim wiederaufgetretenen Glioblastom (GBM) - (SONOBIRD) |
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Title in English |
A randomized, open-label, multicentric, two-arm pivotal trial of SonoCloud-9 combined with carboplatin (CBDCA) vs standard of care lomustine (CCNU) or temozolomide (TMZ) in patients undergoing planned resection for first recurrence glioblastoma |
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Description |
The standard treatment for a recurrent brain tumor usually consists of surgery and chemotherapy. The aim is to inhibit tumor growth. In this study, we are investigating the success of a treatment that is a combination of carboplatin (chemotherapy) and the SC9 implantable device. We want to find out how effective and safe this procedure is compared to standard therapy. |
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Phase/Biobank/etc. |
Phase III |
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Head Clinical Trial |
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Study Coordinator |
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Back-up |
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Status |
active |
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BASEC-Nummer |
2023-D00119 |
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KOFAM |
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WHO-Register-Nummer |
NCT05902169 |
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Insel-Nummer |
5757 |
SwissNOS GluGlio
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Title in German |
Glutamat Signalhemmer für neu diagnostiziertes Glioblastom: eine randomisierte, offene, multizentrische Phase IB/II Studie |
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Title in English |
A phase Ib/II randomized, open label drug repurposing trial of glutamate signaling inhibitors in combination with chemoradiotherapy in patients with newly diagnosed glioblastoma (GLUGLIO) |
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Phase/Biobank/ect. |
Ib/II |
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Description |
The study examines the effectiveness of a combination of the study drugs gabapentin, sulfasalazine and memantine together with standard therapy (radiotherapy and chemotherapy with temozolomide). All three study drugs inhibit the glutamate signaling pathway at different points. Glutamate is a messenger substance found in the human brain that is released by both glioblastoma cells and brain cells. Glutamate promotes the growth and invasion of glioblastoma cells into healthy brain tissue. This is intended to be prevented by additional administration of the three study drugs. |
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Head Clinical Trial |
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Study-Nurse |
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Status |
open for patient recruitment: 01.05.2023 |
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BASEC Nummer |
BASEC2022-01877 |
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KOFAM |
SNCTP000005305 |
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EudraCT No. |
NCT05664464 |
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Insel-Nummer |
5419 |
TRANSEKT
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Title in German |
Vergleich zweier Stimulationsmethoden zur Messung der Bewegungspotenziale während der operativen Entfernung von Hirntumoren im Hinblick auf die Prognosegenauigkeit von Lähmungen nach der Operation (TRANSEKT-Studie) |
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Title in English |
Comparison between transcranial and direct cortical stimulation of motor evoked potentials during the resection of supratentorial brain tumors in terms of prognostic accuracy for postoperative motor deficits: A multicenter parallel-group randomized study |
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Description |
When operating on tumors within the skull, which are located in an area of the brain that, among other things, controls the movement of certain parts of the body (hand, arm, leg or foot), it is necessary to monitor the movement functions during the operation in order to expand the tumor as much as possible remove without impairing the movement function. |
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The aim of this study is to compare two methods of monitoring movement functions: transcranial stimulation and direct cortical stimulation. Transcranial stimulation is carried out using electrodes that are fixed at specific points on the scalp. The direct cortical stimulation is carried out using strip electrodes, which are pushed under the meninges after the skull has been opened and come to rest directly on the surface of the brain. |
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Phase |
II |
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Head Clinical Trial |
PD Dr. med. Tammam Abboud (Bern: Prof. Dr. med. Kathleen Seidel) |
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Study Coordinator |
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Back-up |
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Status |
active since 14.07.2022 |
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BASEC-Nummer |
2021-D0056 |
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Nummer aus Studienregister (z.B. clinicaltrials.gov) |
DRKS00023256 |
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WHO-Register-Nummer |
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Insel-Nummer |
5141 |