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

NCT05842746 | Not Yet Recruiting Phase 2

• 1 other identifier: K3649-I-23PJ571
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioblastoma, IDH-wildtype

Outcome Measures

Primary Outcomes (1)

• 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

  12th month after randomization

Secondary Outcomes (4)

• The overall survival (OS)

  From randomization to death, assessed up to 24 months

• The progression-free survival (PFS)

  From randomization to objective tumor progression or death, assessed up to 24 months

• The progression-free survival (PFS) rate in the 6th month (6m-OS)

  6th month after randomization

• Adverse events

  From randomization to death, assessed up to 24 months

Other Outcomes (1)

• Subgroup analyses for primary and secondary outcomes

  From randomization to death, assessed up to 24 months

Study Arms (2)

Stupp Protocol

PLACEBO COMPARATOR

Patients receive maximal safe tumor resection, concurrent radiochemotherapy with TMZ, and adjuvant TMZ (the Stupp Protocol). Placebo that has the same appearance and flavor with Elemene is given 20ml orally, three times a day for 28 consecutive days (as one cycle) for 6 cycles, during the phase of adjuvant TMZ administration.

Drug: Placebo

Ele-Stupp Protocol

EXPERIMENTAL

Patients receive maximal safe tumor resection, concurrent radiochemotherapy with TMZ, and adjuvant TMZ (the Stupp Protocol). Elemene is given 20ml:176mg orally, three times a day for 28 consecutive days (as one cycle) for 6 cycles, during the phase of adjuvant TMZ administration.

Drug: Elemene

Interventions

Elemene DRUG

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

Ele-Stupp Protocol

Placebo DRUG

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.

Stupp Protocol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

elemene

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Wenbin Ma, MD

  Peking Union Medical College Hospital

  STUDY CHAIR

• Yu Wang, MD, PHD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Wang, MD, PhD

CONTACT

01069152530; ywang@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2023
• First Posted: May 6, 2023
• Study Start: May 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Upon publication.
• Access Criteria: Via communication with the corresponding authors.

Locations

CN (1)