Fig 1.
Schedule of enrolment, interventions and assessments.
a Final study visit procedures can be done within 30 days of study discontinuation/completion of study treatment. b If surgery is deemed to be too risky for patient at pre-screening phase, patient biopsy sample will be used instead if there is sufficient tumor tissue. In addition, tumor may be harvested for any subsequent procedure that patient might require for brain tumor treatment. c If there is a second tissue collection at relapse.
Fig 2.
General study schema for QPOP-guided drug combination therapy.
Subjects will be enrolled to the pre-screening phase of our study at the point of first diagnosis of HGG. Established HGG PDOs from newly diagnosed subjects will be subjected to continuous low dose TMZ and RT as described by the Stupp protocol to model the treatment received in the clinics. QPOP results will be generated from primary HGG PDOs (QPOP-1), matched TMZ/RT-resistant HGG PDOs (QPOP-2). At the point of recurrence, subject will be approached for consent for the main protocol if the PDO generation from their primary tumors was successful. If the subject is found to be suitable for surgery at the time of recurrence, tissue will be collected for the generation of PDOs at recurrence (QPOP-3). QPOP-guided second line systemic treatment will be used in order of preference with available QPOP data from QPOP-3> QPOP-2> QPOP-1. Figure was created with BioRender.com.
Table 1.
Overview of study assessments of the trial.