Status:
UNKNOWN
FDG-PET Scan Response Guided Chemotherapy Strategy for Advanced Non-small Cell Lung Cancer
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Boryung Pharmaceutical Co., Ltd
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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, patien...
Detailed 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) res...
Eligibility Criteria
Inclusion
- Histologically confirmed non-small cell carcinoma.
- Stage IIIB (wet) or IV advanced NSCLC.
- 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.
- Measurable disease by RECIST criteria.
- 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
- 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
- Previous chemotherapy.
- Symptomatic brain metastasis.
- Concurrent severe medical illness.
- Pregnancy and lactation.
- If there are findings which may increase risk with chemotherapy or inhibit to analyze the result of clinical trial.
- Uncontrolled diabetes mellitus.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01170923
Start Date
September 1 2008
Last Update
July 28 2010
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