Efficacy of Post-radiation Adjuvant Temozolomide Chemotherapy in Residue Low-grade Glioma
Phase 3
18 Years
60 Years
18 Years
60 Years
Open (Enrolling)
Both
Astrocytoma, Oligodendroglioma, Oligodendroastrocytoma
Both
Astrocytoma, Oligodendroglioma, Oligodendroastrocytoma
Trial Information
Efficacy of Post-radiation Adjuvant Temozolomide Chemotherapy in Residue Low-grade Glioma
Inclusion Criteria:
- Age: 18 years to 60 years
- Incompletely resected supratentorial WHO II astrocytoma, oligodendroglioma or
oligodendroastrocytoma
- 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
Exclusion Criteria:
- Refusal to participate the study
- Known hypersensitivity or contraindication to temozolomide
- Previous irradiation, prior radiosurgery or prior chemotherapy
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Zhong-ping CHEN, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sun Yat-sen University
Authority:
China: Food and Drug Administration
Study ID:
2012012
NCT ID:
NCT01649830
Start Date:
July 2012
Completion Date:
August 2022
Related Keywords:
- Astrocytoma
- Oligodendroglioma
- Oligodendroastrocytoma
- low-grade glioma
- radiotherapy
- chemotherapy
- Astrocytoma
- Glioma
- Oligodendroglioma
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