PET/CT Scan as a Tool to Rationalize the Treatment of of Advanced NSCLC Patients Undergoing First Chemotherapy

Study Overview
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Brief Summary
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The purpose of this study is to test whether an early metabolic response, measured by PET/CT scan after the first cycle of chemotherapy, is able to predict which patients with advanced NSCLC have a better prognosis.

Official Title
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Study of the Role of Metabolic Response Measured by PET/CT Scan After 1 Cycle of Chemotherapy in Patients With Advanced Non Small Cell Lung Cancer (NSCLC)

Conditions
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Non-small Cell Lung Cancer Metastatic, Non-small Cell Lung Cancer Stage IIIB

Intervention / Treatment
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* Procedure: PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of cytologically or histologically confirmed non-small cell lung cancer. Metastatic (stage IV, both M1A or M1B) or locally advanced (stage IIIB, with metastasis to supraclavicular nodes) according to TNM VII edition. Both patients at first diagnosis or those with disease recurrence after initial surgery are eligible. At least one target or non-target lesion according to RECIST revised version 1.1. Age > or = 18 years . ECOG PS 0-2. Life expectancy > 3 months. Signed informed consent. Exclusion Criteria: Uncontrolled diabetes (glucose > 200 mg/dl EGFR mutation, for those patients who have had testing done. (EGFR test is not required for participation in the study, but may be conducted as part of normal clinical practice, and patients with EGFR mutation would not be candidate for first-line chemotherapy.) Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer or surgically resected prostate cancer with normal PSA). Pregnant or lactating females. Previous medical therapy for metastatic disease (prior surgery, radiation therapy are permitted, as well as adjuvant medical therapy completed at least 6 months prior to study entry). Any poorly controlled illness (including active infections, significant hepatic, renal, metabolic or cardiac disease, myocardial infarction within previous 12 months) that may, according to physician's judgement, interfere with the patient's ability to undergo chemotherapy and/or the examinations within the study protocol Inability to provide informed consent.

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Advanced NSCLC patients undergoing first-line chemotherapy<br>single cohort | Procedure: PET/CT<br>* PET/CT scan at baseline and 3 weeks after first cycle chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in highest value SUVmax (maximum standardized uptake values in PET/CT scan) | To validate as prognostic factor, in terms of overall survival,early metabolic response, defined as a reduction of more than 50% of the highest value of SUVmax recorded at PET/CT scan after one cycle of chemotherapy, compared to the highest value of SUVmax recorded baseline examination | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in SUVmaxsum, TLGmax and TLGmaxsum | to describe and validate early metabolic response as a prognostic factor (in terms of overall survival), using the sum of the SUVmax (SUVmaxsum) , the highest value of TLG (TLGmax), the sum of TLG ( TLGmaxsum). | one year | 
| correlation among SUVmax, SUVmaxsum, TLGmax, TLGsum with progression-free survival | prognostic role of early metabolic response (defined according the above reported 4 parameters) in terms of progression free survival after a first line chemotherapy | one year | 
| correlation among SUVmax, SUVmaxsum, TLGmax, TLGsum with objective response | To describe the association between early metabolic response (defined according the above reported 4 parameters) and objective response according RECIST criteria, measured after 3 cycles of chemotherapy | 3 months | 
| overall survival |  | one year | 
| progression free survival |  | 12 months | 
| objective response |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolic response, chemotherapy