Temozolomide in Relapsed or Advanced Anaplastic Oligodendroglioma and Oligoastrocytoma: Single-arm, Phase II Trial
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Efficacy and Safety of Temozolomide in Patients With Relapsed or Advanced Anaplastic Oligodendroglioma and Oligoastrocytoma: a Multicenter, Single-arm, Phase II Trial|
- Progression free survival (PFS) [ Time Frame: 6 month ]PFS will be examined with Kaplan-Meier method.
- Objective response rate (ORR) [ Time Frame: 1 year ]ORR will be evaluated through the frequency analysis with 95% confidence interval.
- Overall survival (OS) [ Time Frame: 1 years ]OS will be examined with Kaplan-Meier method.
- progression-free survival (PFS) [ Time Frame: 1 year ]PFS will be examined with Kaplan-Meier method.
- Number of Participants with Adverse Events [ Time Frame: 1 years ]Regarding safety endpoints, all adverse events will be individually graded based on the CTCAE version 4.03. The number of participants with adverse events will be summarized using descriptive statistics.
- Predictive biomarker study [ Time Frame: 1 year ]
|Study Start Date:||May 2013|
|Study Completion Date:||March 2016|
|Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Temozolomide 200 mg/m2/d in a fasting state for 5 consecutive days
Temozolomide 200 mg/m2/d in a fasting state for 5 consecutive days (1,000 mg/m2 per 28-day cycle).
Other Name: Temodal
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01847235
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Study Chair:||Tae Min Kim, MD, PhD||Seoul National University Hospital, Seoul, South Korea|