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

NCT00199615 | Completed

• 1 other identifier: I00021
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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

Keywords

lung cancer, 18 FDG, PET

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• - 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

Interventions

PET PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who underwent resection for NSCLC
• Informed consent

You may not qualify if:

• 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 -

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

Pathologie Respiratoire

Limoges, 87042, France

Location

Related Publications (1)

• 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.

  PMID: 20944175 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Boris MELLONI, MD

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 20, 2005
• Study Start: April 1, 2001
• Study Completion: December 1, 2006
• Last Updated: July 30, 2025

Record last verified: 2005-09

Locations

FR (1)