A Explorative Study to Evaluate the Clinical Feasibility of AVATAMED
- Conditions
- Glioblastoma
- Registration Number
- NCT04313842
- Lead Sponsor
- Doo-Sik Kong
- Brief Summary
This is an exploratory study to evaluate the clinical feasibility of medical deivce 'AVATAMED' for predicting the clinical response to TMZ (temozolomide) in glioblasotma patients.
- Detailed Description
Glioblastoma patients who would take TMZ treatment will be screened for in vitro drug screening experiment. Patients whose tumor specimen pass the drug screening process will be finally enrolled.
Actual clinical response to TMZ treatment will be compared to drug screening results derived from AVATAMED, a medical software device to predict the drug response based on in vitro assay using patient-derived tumor cells.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- written informed consent
- histologically confirmed glioblastoma patients who will take TMZ treatment
- KPS >70
- adequte end-organ function
- prior major surgery > 4 weeks (prior minor surgery > 1weeks)
- prior standard concurrent chemo-radiation therapy > 4 weeks
- prior radiation therapy (including stereotactic radiosurgery) > 12 weeks
Exclusion Criteria
- contraindication to TMZ
- prior anti-cancer therapy except standard of care (*standard of care includes surgery, Stupp regimen, and radiotherapy)
- uncontrolled systemic medical illness
- pregnancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 6 month PFS rate 6 month the fraction of patients without disease progression at 6 months after the TMZ treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of