Efficacy and Safety of Elemene Plus Stupp Protocol Versus Stupp Protocol Alone for Newly-diagnosed Glioblastoma: A Multi-center Phase II Randomized Controlled Trial
Trial ID: NCT05842746
Interventional - Phase 2 - Not yet recruiting
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.
Conditions
Glioblastoma, IDH-wildtype
Interventions
Elemene
Placebo
Eligibility
Inclusion criteria
- 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
adequate bone marrow function (white blood cell ≥ 2.0 × 10^9/L, neutrophils ≥ 1.5 × 10^9/L, hemoglobin ≥ 90 g/L, and platelets ≥ 100 × 10^9/L)
adequate hepatic function (direct bilirubin and indirect bilirubin ≤ 1.5 mg/dL, and alanine aminotransferase [ALT] and aspartate aminotransferase [AST] < 4 times the upper limit of normal)
adequate renal function (creatinine < 80 umol/L)
adequate coagulation function (international normalized ratio [INR] ≤ 1.3)
voluntary to participate in this trial, complete all pre-specified treatment regimens, and complete required follow-up
Exclusion criteria
- 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
severe liver and kidney dysfunction, coagulation disorders, or decreased hematopoietic ability
serious infection
serious hyperlipidaemia
medical illness or psychosocial circumstance that may compromise participant safety