Prevention of Tumor Spread Due to Lung Cancer Surgery

Completed

Conditions studied: Non-Small Cell Lung Cancer

In brief

This study will investigate operative techniques to reduce the risk of tumor spread as a result of lung cancer surgery. Recent studies indicate that tumor cells may be released into the bloodstream due to handling of the lung during surgery, causing disease spread in patients whose tumor was previously confined to the lung. This study will examine whether the order in which the pulmonary vein (a vessel carrying blood from the lungs to the heart) and artery (vessel carrying blood from the heart to the lungs) are tied off during surgery affects the risk of tumor spread and disease recurrence. Patients 18 years of age or older with operable Stage I or Stage II non-small cell lung cancer and no evidence of tumor spread beyond the lung may be eligible for this study. Candidates will be screened with a medical history, blood tests, chest X-ray, and possibly mediastinal evaluation. This test involves inserting a tube into the chest cavity to look for signs of disease spread beyond the lung. All participants will undergo standard surgery for lung cancer. During the procedure, both the pulmonary artery and pulmonary vein are tied off; for this study, patients will be randomly assigned to have either the artery or the vein ligated first. Patients will be followed every 6 months for two years with blood tests and X-rays to look for disease recurrence. ...

Key facts

Study ID

NCT00341380

Run by

National Institute of Environmental Health Sciences (NIEHS)

People needed

41

Starts

2002-09-24

Expected to finish

2019-12-17

Last updated by the study team

2020-01-06

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients with prior carcinoma within 5 years (except basal cell carcinoma of the skin and superficial bladder cancer) will be excluded from the study. Patients who are enrolled based on clinical Stage I or II but are revised to higher Stage once the surgical specimens are examined will be excluded from statistical analysis.

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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