NCT05842746Not yet recruitingPhase 2
Elemene Plus Stupp Protocol Versus Stupp Protocol Alone for Newly-diagnosed Glioblastoma
Efficacy and Safety of Elemene Plus Stupp Protocol Versus Stupp Protocol Alone for Newly-diagnosed Glioblastoma: A Multi-center Phase II Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 6 May 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 74 (estimated)
- First submitted
- 9 Apr 2023
- Start date
- May 2023
- Primary completion date
- Dec 2026
- Lead sponsor
- Peking Union Medical College Hospital
- Diseases
- Glioblastoma
- NCT number
- NCT05842746
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 74
- From May 2023 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- prior treatment (surgery, radiotherapy, chemotherapy) for glioblastoma
Other illness
- allergic to Elemene and its components
- severe liver and kidney dysfunction, coagulation disorders, or decreased hematopoietic ability
- serious infection
- medical illness or psychosocial circumstance that may compromise participant safety
Other
- unwilling to participate or accept the pre-specified treatment regimen and required follow-up schedule
- pregnant or lactating patients
- serious hyperlipidaemia
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.