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NOT YET RECRUITING
NCT05842746
PHASE2

Elemene Plus Stupp Protocol Versus Stupp Protocol Alone for Newly-diagnosed Glioblastoma

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

Elemene

Elemene of 20ml is given orally, three times a day, for 28 consecutive days (as a cycle), for 6 cycles.

DRUG

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