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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT00199615
First received: September 14, 2005
Last updated: October 30, 2007
Last verified: September 2005
History of Changes
  Purpose

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.


Condition Intervention
Non-Small Cell Lung Cancer
 Procedure: PET

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Follow-up of Patients With Curative-Intent Surgical Resection for NSCLC : CT Scanning Versus 18 FDG Imaging.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • 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:
  • - 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

Enrollment: 73
Study Start Date: April 2001
Study Completion Date: December 2006
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00199615

Locations
France
Pathologie Respiratoire
Limoges, France, 87042
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: Boris MELLONI, MD University Hospital, Limoges
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00199615     History of Changes
Other Study ID Numbers: I00021
Study First Received: September 14, 2005
Last Updated: October 30, 2007
Health Authority: France : DGS

Keywords provided by University Hospital, Limoges:
lung cancer, 18 FDG, PET

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013