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

Primary Purpose

Non-Small Cell Lung Cancer

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

PET

About this trial

This is an interventional diagnostic trial for Non-Small Cell Lung Cancer focused on measuring lung cancer, 18 FDG, PET

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

Pathologie Respiratoire

Outcomes

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

Full Information

NCT ID

NCT00199615

First Posted

September 14, 2005

Last Updated

October 30, 2007

Sponsor

University Hospital, Limoges

1. Study Identification

Unique Protocol Identification Number

NCT00199615

Brief Title

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

Official Title

Follow-up of Patients With Curative-Intent Surgical Resection for NSCLC : CT Scanning Versus 18 FDG Imaging.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Completed

Study Start Date

April 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Limoges

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Small Cell Lung Cancer

Keywords

lung cancer, 18 FDG, PET

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

73 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

PET

Intervention Description

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.

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

- Overall survival from the date of the operation to the death

Title

- Specificity, sensibility and accuracy of TEP to detect recurrence

Title

- Direct cost of follow-up from the Frenc Healthcare insurance

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boris MELLONI, MD

Organizational Affiliation

University Hospital, Limoges

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pathologie Respiratoire

City

Limoges

ZIP/Postal Code

87042

Country

France

12. IPD Sharing Statement

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

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