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

Not Applicable

Completed

• Conditions: Non-Small Cell Lung Cancer

• Registration Number: NCT00199615
• Lead Sponsor: University Hospital, Limoges

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-04
• Status Verified: 2005-09
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-20
• Study Completion: 2006-12
• Last Update Submitted: 2007-10-30
• Last Update Posted: 2007-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
- 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

Trial Locations

Locations (1)

Pathologie Respiratoire; 🇫🇷 Limoges, France