The Efficacy and Safety of Temozolomide in Patients With Relapsed or Advanced Anaplastic Oligodendroglioma and Oligoastrocytoma: a Multicenter, Single-arm, Phase II Trial
Patient with relapsed or advanced anaplastic oligodendroglioma and anaplastic
oligoastrocytoma will be enrolled. Enrolled patients will begin on temozolomide 200 mg/m2/d
in a fasting state for 5 consecutive days (1,000 mg/m2 per 28-day cycle). Patients who were
previously treated with any chemotherapy initially received temozolomide 150 mg/m2/d for 5
days (750 mg/m2 per cycle).Patients will be receving a total 6 cycles of chemotheray
(4weeks/cycle * 6cycles = 24weeks). If the patients shows responses to Temozolomide,
treatment can be continued by the investigator's discretion.
During the administration of Temozolomide, vital signs, physical examination, ECOG
performance status, height, weight, hematology and chemistry test, adverse events and
concomitant drugs will be evaluated every four weeks. Brain MRI for tumor assessment will be
performed once every 12 weeks.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival (PFS)
PFS will be examined with Kaplan-Meier method.
Se-Hoon LEE, MD, PhD
Seoul National University Hospital, Seoul, South Korea
South Korea: Korea Food and Drug Administration (KFDA)