Glioblastoma, IDH-wildtypePhase 2NCT05842746
Elemene Plus Stupp Protocol Versus Stupp Protocol Alone for Newly-diagnosed Glioblastoma
A Phase 2 study testing Elemene in people with Glioblastoma, IDH-wildtype, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma, IDH-wildtype
- What is being tested?
- Elemene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- May 2023to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital
Beijing
Yu Wang, MD, PhD, ywang@pumch.cn
Xiaopeng Guo, MD, guoxiaopeng_pumch@163.com
About this study
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
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.
Read the detailed description
Glioblastoma (GBM) is a WHO grade 4 adult-type diffuse glioma and the most common malignant, primary brain tumor with a 5-year overall survival (OS) of only ~5% in real-world studies. The Stupp Protocol, consisting of fractionated focal irradiation in daily fractions of 2 Gy given 5 days/week for 6 weeks (a total of 60 Gy), plus concomitant daily temozolomide (TMZ, 75 mg/m2/day, 7 days/week from the first to the last day of radiotherapy) after maximal safe tumor resection, followed by six cycles of adjuvant TMZ (150-200 mg/m2/day for 5 days during each 28-day cycle), has been adopted as the standard of care for patients with newly-diagnosed GBMs (ndGBMs) since 2005.
However, there have been no other treatment modalities except for tumor treating fields (TTFields) that have brought survival benefits for ndGBM patients during the past two decades. Since TTFields therapy is super expensive (about 1 million yuan/0.15 million dollars per year) and fewer than 10% of ndGBM patients can afford it around the globe, the Stupp Protocol is still being used as the first-line and the most widely-adopted treatment option for ndGBM patients around the world.
Elemene, a Chinese anti-tumor medicine extracted from the plant Curcuma Wenyujin, has been isolated as a monomeric drug and has a broad-spectrum anti-tumor effect in various cancers, such as lung cancer, breast carcinoma, leukemia, and ovarian cancer. In recent years, its application in GBMs as revealed in the preliminary retrospective studies published in Chinese Journals and a few English Journals have shown survival benefits with acceptable toxicity. Elemene can pass through the blood-brain barrier because of its small molecular weight and lipid solubility and has synergistic anti-tumor effects with TMZ and radiotherapy for GBM patients. Several in vitro studies also have shown that Elemene could inhibit GBM cell proliferation, promote cell differentiation, and induce cancer cell apoptosis.
All these findings from the above studies have indicated the potential survival benefits of Elemene in treating ndGBMs. However, so far, no clinical trials have tested the efficacy and safety of the new treatment protocol (Elemene added to the Stupp Protocol) for ndGBMs compared with the conventional Stupp protocol.
In this study, the investigators aimed to launch a multi-center, phase II, randomized, controlled clinical trial to test the safety and efficacy of Elemene plus Stupp Protocol compared with Stupp Protocol alone for ndGBM patients.
- Conditions
- Glioblastoma, IDH-wildtype
- Being tested
- Elemene, Placebo
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElemeneDrug
Elemene of 20ml is given orally, three times a day, for 28 consecutive days (as a cycle), for 6 cycles.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Elemene |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12th month after randomization
Secondary outcomes (4)
The overall survival (OS)
The survival time from randomization to death from any cause
Measured: From randomization to death, assessed up to 24 months
The progression-free survival (PFS)
The survival time from randomization to objective tumor progression or death
Measured: 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)
The rate of patients who have no objective tumor progression in the 6th month after randomization
Measured: 6th month after randomization
Adverse events
Adverse events evaluated using the CTCAE version 4.03
Measured: From randomization to death, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study startMay 2023 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma, IDH-wildtypeStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenbin Ma, MD, Study chair, Peking Union Medical College HospitalYu Wang, MD, PHD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842746
- Sponsor's protocol ID
- K3649-I-23PJ571
- Status last verified
- Apr 2023
- First submitted
- 9 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) can be made available upon publication.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05842746
- Acronym / sponsor ID
- K3649-I-23PJ571
- Conditions
- Glioblastoma, IDH-wildtype
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Glioblastoma (GBM) is a WHO grade 4 adult-type diffuse glioma and the most common malignant, primary brain tumor with a 5-year overall survival (OS) of only ~5% in real-world studies. The Stupp Protocol, consisting of fractionated focal irradiation in daily fractions of 2 Gy given 5 days/week for 6 weeks (a total of 60 Gy), plus concomitant daily temozolomide (TMZ, 75 mg/m2/day, 7 days/week from the first to the last day of radiotherapy) after maximal safe tumor resection, followed by six cycles of adjuvant TMZ (150-200 mg/m2/day for 5 days during each 28-day cycle), has been adopted as the standard of care for patients with newly-diagnosed GBMs (ndGBMs) since 2005.
However, there have been no other treatment modalities except for tumor treating fields (TTFields) that have brought survival benefits for ndGBM patients during the past two decades. Since TTFields therapy is super expensive (about 1 million yuan/0.15 million dollars per year) and fewer than 10% of ndGBM patients can afford it around the globe, the Stupp Protocol is still being used as the first-line and the most widely-adopted treatment option for ndGBM patients around the world.
Elemene, a Chinese anti-tumor medicine extracted from the plant Curcuma Wenyujin, has been isolated as a monomeric drug and has a broad-spectrum anti-tumor effect in various cancers, such as lung cancer, breast carcinoma, leukemia, and ovarian cancer. In recent years, its application in GBMs as revealed in the preliminary retrospective studies published in Chinese Journals and a few English Journals have shown survival benefits with acceptable toxicity. Elemene can pass through the blood-brain barrier because of its small molecular weight and lipid solubility and has synergistic anti-tumor effects with TMZ and radiotherapy for GBM patients. Several in vitro studies also have shown that Elemene could inhibit GBM cell proliferation, promote cell differentiation, and induce cancer cell apoptosis.
All these findings from the above studies have indicated the potential survival benefits of Elemene in treating ndGBMs. However, so far, no clinical trials have tested the efficacy and safety of the new treatment protocol (Elemene added to the Stupp Protocol) for ndGBMs compared with the conventional Stupp protocol.
In this study, the investigators aimed to launch a multi-center, phase II, randomized, controlled clinical trial to test the safety and efficacy of Elemene plus Stupp Protocol compared with Stupp Protocol alone for ndGBM patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stupp Protocol | Placebo comparator | Drug: PlaceboPatients 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. |
| Ele-Stupp Protocol | Experimental | Drug: ElemenePatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElemeneElemene of 20ml is given orally, three times a day, for 28 consecutive days (as a cycle), for 6 cycles. | Drug | Ele-Stupp Protocol |
| PlaceboPlacebo (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. | Drug | Stupp Protocol |
Primary outcome
The overall survival (OS) rate in the 12th month (12m-OS)
Time frame: 12th month after randomization
The rate of patients who are still alive in the 12th month after randomization
4 secondary outcomes
The overall survival (OS)
Time frame: From randomization to death, assessed up to 24 months
The progression-free survival (PFS)
Time frame: 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)
Time frame: 6th month after randomization
Adverse events
Time frame: From randomization to death, assessed up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) can be made available upon publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenbin Ma, MD study chair
Peking Union Medical College Hospital
Yu Wang, MD, PHD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Elemene in people with Glioblastoma, IDH-wildtype, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Wang, MD, PhD (01069152530, ywang@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall survival (OS) rate in the 12th month (12m-OS) (time frame: 12th month after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.