FDG-PET Scan Response Guided Chemotherapy Strategy for Advanced Non-small Cell Lung Cancer
Recruitment status was Active, not recruiting
The usual response to chemotherapy is decided through the image change by computed tomography (CT), which is taken at least 6-9 weeks.
In order to predict the response to chemotherapy earlier, patients received FDG-PET scan at the first cycle of chemotherapy. Chemotherapy was guided by the metabolic response by FDG-PET scan.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Standard Chemotherapy Strategy Versus Changing Chemotherapy Strategy as to FDG-PET Response After 1st Cycle of Standard Chemotherapy for Advanced Non-small Cell Lung Cancer|
- change in response rate [ Time Frame: within 4 cycles ] [ Designated as safety issue: No ]The usual response rate of GenexolPM/Cisplatin chemotherapy is 30-40%. This trial will assess whether the changing chemotherapy strategy using FDG-PET can increase response rate by 15%.
|Study Start Date:||September 2008|
|Estimated Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Experimental: FDG-PET guided
Chemotherapy regimen will be changed depending on metabolic response.
FDR-PET performed after 1 cycle of chemotherapy
Active Comparator: CT guided
Chemotherapy regimen will be changed depending on CT findings (RECIST).
CT performed after 3 cycles of chemotherapy
Prospective, Open-label, Randomized phase II, single institution trial that compared chemotherapy guided by traditional evaluation based on RECIST versus chemotherapy guided by FDG-PET (metabolic) response.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170923
|Principal Investigator:||Sang-We Kim, MD||Asan Medical Center|