Clinical trial · Interventional
A Study on β-elemene as Maintain Treatment for Newly Diagnosed Malignant Gliomas
A Study on β-elemene as Maintain Treatment for Complete Remission Patients of Newly Diagnosed Malignant Gliomas Following Standard Treatment
NCT02629757CI-TRIAL-00031777β-elemeneunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is being conducted to help determine whether β-elemene as maintain treatment for complete remission patients of newly diagnosed malignant gliomas following standard treatment, is able to delay tumor growth, or impact how long people with newly diagnosed high-grade glioma.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Astrocytoma | Anaplastic Astrocytoma | CURATED_BROADER | 0.80 |
| Anaplastic Oligoastrocytoma | Anaplastic Oligoastrocytoma | CURATED_BROADER | 0.80 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| β-elemene | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- β-elemene
- description
- β-elemene 600mg/d,ivdrip,d1-14,every 28 days for 1 cycle, totally 6 cycles.
- interventionNames
- Drug: β-elemene
Primary outcomes (1)
- measure
- Over-all survival
- timeFrame
- 5-year
Secondary outcomes (1)
- measure
- Quality of life
- timeFrame
- 5-year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * \- Page 3 of 4 \[DRAFT\] - Arms Assigned Interventions * Temodar Experimental: temozolomide +α-IFN Four weeks after radiotherapy, patients will be received 6 cycle of temozolomide plus α-IFN α-IFN： 3mIU (3million) Day1,3,5 of each 28 day TMZ：150 mg/m\^2 daily on Days 2-6 of each 28 day study cycle and 200 mg/m\^2 daily of subsequent cycles Drug: Temozolomide dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days Other Names: • Temodar Drug: α-IFN 3mIU (3million) D1，3，5 Other Names: Minimum Age: 18 Years Maximum Age: 75 Years Gender: Both Accepts Healthy Volunteers?: No Criteria: Inclusion Criteria: * Age: 18 years to 75 years * complete remission patients of newly diagnosed WHO III-IV glioma following standard treatment * Karnofsky Performance Score ≥ 60 * Adequate bone marrow, liver and renal function * Ability of subject to understand character and individual consequences of the clinical trial * Written informed consent * anticipating survival ≥2 months Exclusion Criteria: * Refusal to participate the study * Known hypersensitivity or contraindication to temozolomide * Incompletely radiation * Pregnant or lactating females * Malignant tumor other than brain tumor * Contraindicated for MRI examination * Unable to comply with the follow-up studies of this trial * Purulent and chronic infected wounds * Uncontrolled psychotic disorders or epilepsy * progression disease
References
Publications (0)
Data not yet available
No reference posted for this study.