FDG-PET Scan Response Guided Chemotherapy Strategy for Advanced Non-small Cell Lung Cancer
This trial is active, not recruiting.
|Condition||non-small cell lung cancer|
|Sponsor||Asan Medical Center|
|Collaborator||Boryung Pharmaceutical Co., Ltd|
|Start date||September 2008|
|End date||August 2010|
|Trial size||100 participants|
|Trial identifier||NCT01170923, AMC 08-351|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
change in response rate
time frame: within 4 cycles
Male or female participants at least 18 years old.
Inclusion Criteria: 1. Histologically confirmed non-small cell carcinoma. 2. Stage IIIB (wet) or IV advanced NSCLC. 3. No evidence of prior malignancies for 3 years except treated basal cell or squamous cell carcinoma of skin and carcinoma in situ of uterine cervix. 4. Measurable disease by RECIST criteria. 5. Adequate organ function as follows. - Seum AST/ALT < 2.5 x Upper normal limit (UNL) (if hepatic metastasis < 5 x UNL) - Total bilirubin < 1.5 x UNL - Serum creatinine < 1.5 mg/dL - Absolute neutrophil count > 1500/uL - Platelet > 100,000/uL - Hemoglobin > 9.0 g/dL 6. ECOG Performance status 0-1 7 Age > 18 8. If previously treated with major surgery, it should be over at least 4 weeks. And if previously treated with radiotherapy, it should be over at least 2 weeks. 9. Written consent Exclusion Criteria: 1. Previous chemotherapy. 2. Symptomatic brain metastasis. 3. Concurrent severe medical illness. 4. Pregnancy and lactation. 5. If there are findings which may increase risk with chemotherapy or inhibit to analyze the result of clinical trial. - Uncontrolled diabetes mellitus.
|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|
|Principal investigator||Sang-We Kim, MD|
|Description||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.|
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