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Elemene Plus Stupp Protocol Versus Stupp Protocol Alone for Newly-diagnosed Glioblastoma
Sponsor: Peking Union Medical College Hospital
Summary
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.
Official title: Efficacy and Safety of Elemene Plus Stupp Protocol Versus Stupp Protocol Alone for Newly-diagnosed Glioblastoma: A Multi-center Phase II Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
74
Start Date
2023-05
Completion Date
2027-05
Last Updated
2023-05-06
Healthy Volunteers
No
Conditions
Interventions
Elemene
Elemene of 20ml is given orally, three times a day, for 28 consecutive days (as a cycle), for 6 cycles.
Placebo
Placebo (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.
Locations (1)
Peking Union Medical College Hospital
Beijing, China