FDG-PET Scan Response Guided Chemotherapy Strategy for Advanced Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Device: FDR-PET
* Device: CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FDG-PET guided<br>Chemotherapy regimen will be changed depending on metabolic response. | Device: FDR-PET<br>* FDR-PET performed after 1 cycle of chemotherapy<br>|
| Active Comparator: CT guided<br>Chemotherapy regimen will be changed depending on CT findings (RECIST). | Device: CT<br>* CT performed after 3 cycles of chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in response rate | 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%. | within 4 cycles | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non small cell lung cancer, FDG PET