Non-small Cell Lung Cancer
Conditions
Keywords
lung cancer, 18 FDG, PET
Brief summary
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.
Interventions
PROCEDUREPET
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.
Sponsors
University Hospital, Limoges
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | 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
| Measure | 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 | — |
Countries
France
Outcome results
None listed