Follow-up of Patients With Curative-Intent Surgical Resection for NSCLC

Study Overview
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Brief Summary
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The guidelines and institutional practices recommended more frequent visits the two years following curative-intent therapy for non-small cell lung cancer (NSCLC).No international consensus is published concerning follow-up of resected NSCLC patients.Recent studies have outlined that positron emission tomography (PET) scanning may be accurate in early detection of recurrences by comparison to computed tomography (CT). The aim of this study is to compare follow-up by conventional methods versus PET. Patients are randomly assigned to two arms. In the first arm, thorax CT with liver and adrenal gland sections, abdominal ultrasonography and nuclear bone scintigraphy are performed every 6 months after surgery for two years. In the second arm, PET scanning is only. For brain metastasis detection, CT is performed in the two arms. Recurrences are detected during scheduled or unscheduled procedure in asymptomatic patients. PET and CT are interpreted separately by two nuclear physicians and two radiologists. The direct cost of follow-up procedure is determined in the two groups. The calculated sample is composed of 60 patients in each arm to detect significant difference. The Ethics Committee of Universitary Hospital of Limoges approves the study.

Official Title
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Follow-up of Patients With Curative-Intent Surgical Resection for NSCLC : CT Scanning Versus 18 FDG Imaging.

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Procedure: PET


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients who underwent resection for NSCLC Informed consent Exclusion Criteria: Patients with a mixed histology profile that included small cell carcinoma or neuroendocrine tumor cells. Patients with non-resected NSCLC or with metastasis Patients who have previous malignancy, except basal cell carcinoma of the skin -

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

| Intervention/Treatment |
| --- |
|Procedure: PET|Intravenous injection of glucose labeled Fluor 18.Le patient remains fasted at least 6 hours before the start of the examination. The review lasted 1 hour, during which the patient should not move.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival from the date of operation to the date of recurrence or censured at the date of last follow-up visit or date of the death. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Overall survival from the date of the operation to the death |  |  | 
| - Specificity, sensibility and accuracy of TEP to detect recurrence |  |  | 
| - Direct cost of follow-up from the Frenc Healthcare insurance |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, 18 FDG, PET