The goal of this phase II randomized clinical trial is to compare the safety and efficacy of Elemene plus Stupp Protocol (the new protocol) and Stupp Protocol alone (the standard protocol) in patients with newly-diagnosed glioblastomas (ndGBMs). The main questions to answer are:
* Whether the new treatment protocol (Elemene plus Stupp Protocol) is clinically safe for ndGBM patients. * Whether the new treatment protocol (Elemene plus Stupp Protocol) brings better survival benefits for ndGBM patients compared to the standard-of-care Stupp Protocol.
Study participants will be enrolled in 5 hospitals in China and randomly assigned to receive either the new protocol or the standard protocol. The overall survival (OS) rate in the 12th month, the progression-free survival (PFS) rate in the 6th month, OS, PFS, and adverse events assessed by the CTCAE (Common Terminology Criteria for Adverse Events) will be evaluated for all patients.
newly-diagnosed supratentorial glioblastoma, IDH-wildtype, WHO grade 4
male or female adult patients < 70 years old
Karnofsky performance status (KPS) score higher or equal to 60
a minimum life expectancy of 12 weeks
unwilling to participate or accept the pre-specified treatment regimen and required follow-up schedule
prior treatment (surgery, radiotherapy, chemotherapy) for glioblastoma
pregnant or lactating patients
allergic to Elemene and its components
Parallel
Elemene
DrugElemene of 20ml is given orally, three times a day, for 28 consecutive days (as a cycle), for 6 cycles.
Placebo
DrugPlacebo (with the same appearance and flavor with Elemene) of 20ml is given orally, three times a day, for 28 consecutive days (as a cycle), for 6 cycles.
The overall survival (OS) rate in the 12th month (12m-OS)
The rate of patients who are still alive in the 12th month after randomization
The overall survival (OS)
The survival time from randomization to death from any cause
The progression-free survival (PFS)
The survival time from randomization to objective tumor progression or death
The progression-free survival (PFS) rate in the 6th month (6m-OS)
The rate of patients who have no objective tumor progression in the 6th month after randomization
Adverse events
Adverse events evaluated using the CTCAE version 4.03
Subgroup analyses for primary and secondary outcomes
Subgroups to be divided by sex, age, molecular alterations, KPS score, and extent of resection.
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This trial is not recruiting at the moment. You can still explore other options:
