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

NCT ID: NCT00199615

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30
• Study Completion Date: 2006-12-31

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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 -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boris MELLONI, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Limoges

Locations

Pathologie Respiratoire

Limoges, , France

Countries

France

References

Monteil J, Vergnenegre A, Bertin F, Dalmay F, Gaillard S, Bonnaud F, Melloni B. Randomized follow-up study of resected NSCLC patients: conventional versus 18F-DG coincidence imaging. Anticancer Res. 2010 Sep;30(9):3811-6.

Reference Type: BACKGROUND

PMID: 20944175 (View on PubMed)

Other Identifiers

I00021

Identifier Type: -

Identifier Source: org_study_id