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

U

University of Limoges (UL)

Status

Completed

Conditions

Non-small Cell Lung Cancer

Treatments

Procedure: PET

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

73 patients

Sex

All

Ages

18+ years old

Volunteers

No 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 -

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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