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

Sponsored by:	University Hospital, Limoges
Information provided by:	University Hospital, Limoges
ClinicalTrials.gov Identifier:	NCT00199615

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

MedlinePlus related topics: Cancer Lung Cancer Nuclear Scans

Drug Information available for: Dextrose Fluorodeoxyglucose F18

U.S. FDA Resources

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

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:

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

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

Keywords provided by University Hospital, Limoges:

lung cancer, 18 FDG, PET

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 15, 2009