Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02893137 | Enhancing Optune Therapy With Targeted Craniectomy | PHASE1 | COMPLETED | 15 | — | — | Oct 1, 2016 | May 31, 2019 | Nov 27, 2019 | 1 | Denmark |
Based on CTCAE.
| Arm | Type | Description |
|---|---|---|
| Craniectomy and Optune | EXPERIMENTAL | Patients will receive best physician's choice chemotherapy along with Optune therapy and craniotomy surgery. Optune therapy will be administered in the standard configuration and in accordance with current guidelines with the exception of the surgical intervention. |
| Name | Type | Description |
|---|---|---|
| Optune | DEVICE | For further information see www.optune.com |
| Craniectomy | PROCEDURE | A small hole is placed in the skull between the tumor and the closest Optune electrode. The position and geometry of the craniotomy is determined by computersimulation of the electric field induced by Optune therapy. Craniotomy is a surgical procedure, which is carried out under general anaesthesia. |
Inclusion Criteria: * Pathological evidence of GBM using WHO classification criteria * Estimated survival minimum three months * Supratentorial tumor * Not a candidate for further radiotherapy * First disease recurrence in accordance with RANO criteria * Karnofsky scale score minimum 70 * Ability t...