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A Phase III Randomized Trial of Lobectomy versus Sublobar Resection for Small (<2cm) Peripheral Non-Small Cell Lung Cancer.

IRB Number

12-491

ClinicalTrials.gov Identifier

NCT00499330

Trial Status

Open for Enrollment
Phase 3

Why is this study being done?

The purpose of this study is to test a different way of doing surgery for lung cancer in patients who have small tumors with no evidence it has spread. Recent studies have questioned whether removing a larger portion of the lung containing the tumor offers much better control of the cancer than removing a smaller section of the lung. The purpose of this clinical trial is to look at whether removal of a small section of the lung (called a sublobar resection) is as effective as a lobectomy (a more extensive surgery which removes the entire section or lobe of the lung.) This is about one quarter to one half of one lung depending on which lobe is removed. This clinical trial will study the over-all effects (good and/or bad) of a sublobar resection compared to a lobectomy.

Who is eligible to participate?

Patients with peripheral non-small cell lung cancer and have a tumor which is 2 cm or smaller in size.

What is involved?

You will need to have the following exams, tests, or procedures to determine if you fit the criteria to be in the study. These exams, tests and procedures are a routine part of your care and may be done even if you do not join the study. If you have had some of them done recently, they may not need to be repeated. This will be determined by the study doctor. You will be asked to give your medical history and have a physical examination. You will have pulmonary function tests. A chest C.T. scan will be done to measure tumor size. You may or may not have a PET scan to determine where the tumor is and if it has spread. During surgery the study doctor will determine if the tumor meets the study criteria. If it does you will be randomly selected by a computer program to be in one of the study groups. Group 1 will have a standard lobectomy or removal of the entire lobe. Group 2 will have a sublobar resection which removes a smaller section of the lung. The entire tumor will be removed regardless of which study group you are in. You will have tests and procedures that are a part of regular care but they may be done more often for the study than you would routinely have after surgery. Pulmonary function tests will be done 6 months after surgery. A chest X-ray and CT scan will be done every 6 months for 2 years then yearly for an additional 5 years. PET scans may or may not be done if the study doctor determines they are needed to review your progress.

How long is the study?

Following the surgery, if you have been randomized to a group, the study doctor will ask you to come for exams as a part of the study at least every 6 months for 2 years, then yearly for another 5 years. These are routine follow-up visits after surgery for lung cancer.

Who can I contact for additional information?

You may contact Theresa Boley, RN, MSN, APN/FNR,CCRP at 217.545.5000.

Who is the Principal Investigator of this study?

Stephen Hazelrigg, MD

Where is the trial located?

Springfield, Illinois