Dose and Volume Escalation of Preoperative Brain Irradiation in GBM Patients -the POBIG Trial - (POBIG)
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|ClinicalTrials.gov Identifier: NCT03582514|
Recruitment Status : Withdrawn (The participating site went broke and no new participating sites have been found)
First Posted : July 11, 2018
Last Update Posted : April 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme||Radiation: Preoperative brain irradiation (single fraction)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Cohort inclusion is based on a 3+3 design. Three patients each are assigned to the Level 1 combinations of dose and volume. Each patient triplet is considered a cohort.|
|Masking:||None (Open Label)|
|Official Title:||Dose and Volume Escalation of Preoperative Brain Irradiation in GBM Patients -the POBIG Trial -|
|Estimated Study Start Date :||December 1, 2019|
|Actual Primary Completion Date :||December 1, 2019|
|Actual Study Completion Date :||December 1, 2019|
Experimental: Dose or volume radiation escalation
Patients with a biopsy proven GBM referred to our hospital or patients who are diagnosed with GBM based on the MRI (judged by the neuro-oncology multidisciplinary team) are to be considered for this study.
This GBM study assesses the feasibility, safety and efficacy of a preoperative single fraction. The phase-I part has a 3+3 dose or volume escalation design. The choice of dose or volume escalation is based on tumor volume and location. After the single fraction of radiotherapy, patients will receive the standard treatment.
Radiation: Preoperative brain irradiation (single fraction)
Dose and volume escalation of preoperative single fraction stereotactic radiotherapy.
- The feasibility of preoperative single fraction radiotherapy in GBM patients [ Time Frame: 4 years ]To assess the tumor control and (re)growth between surgery and post-operative radiotherapy.
- The single fraction dose and volume that can be safely given preoperatively [ Time Frame: 4 years ]To explore the single fraction dose and volume that can be safely given in a preoperative setting additional to the standard treatment of postoperative surgery and (chemo)radiation.
- The tumor volume differences measured between the post-surgery MRI and pre-radiotherapy MRI [ Time Frame: 4 years ]To confirm usability of the MRI to select GBM patients for preoperative single fraction radiotherapy.
- Registration of postoperative surgical complications. [ Time Frame: 4 years ]
- Progression free survival. [ Time Frame: 4 years + 5 years follow-up ]
- Overall survival. [ Time Frame: 4 years + 5 years follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03582514
|The Netherlands Cancer Institute|
|Amsterdam, Noord-Holland, Netherlands, 1066CX|
|Medisch Centrum Slotervaart|
|Amsterdam, Noord-Holland, Netherlands, 1066EC|
|Principal Investigator:||Gerben R Borst||The Netherlands Cancer Institute|