Phase III Randomized Study of Lobectomy Versus Sublobar Resection in Patients With Small Peripheral Stage IA Non-Small Cell Lung Cancer

Status
Completed
Cancer Type
Lung Cancer
Trial Phase
Phase III
Eligibility
18 and over, Male and Female
Study Type
Treatment
NCD ID
NCT00499330
Protocol IDs
CALGB-140503 (primary)
CALGB-140503
ECOG-40503
Study Sponsor
Cancer and Leukemia Group B

Summary

Rationale

Wedge resection(wej ree-SEK-shun)

Surgery to remove a triangle-shaped slice of tissue. It may be used to remove a tumor and a small amount of normal tissue around it.
or segmentectomy(seg-men-TEK-toh-mee)

Surgery to remove part of an organ or gland. It may also be used to remove a tumor and normal tissue around it. In lung cancer surgery, segmentectomy refers to removing a section of a lobe of the lung. Also called segmental resection.
may be less invasive types of surgery(SER-juh-ree)

A procedure to remove or repair a part of the body or to find out whether disease is present. An operation.
than lobectomy(loh-BEK-toh-mee)

Surgery to remove a whole lobe (section) of an organ (such as the lungs, liver, brain, or thyroid gland).
for non-small cell lung cancer(... sel lung KAN-ser)

A group of lung cancers that are named for the kinds of cells found in the cancer and how the cells look under a microscope. The three main types of non-small cell lung cancer are squamous cell carcinoma, large cell carcinoma, and adenocarcinoma. Non-small cell lung cancer is the most common kind of lung cancer.
and may have fewer side effectsA problem that occurs when treatment affects healthy tissues or organs. Some common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores. and improve recovery. It is not yet known whether wedge resection or segmentectomy are more effective than lobectomy in treating stage IA non-small cell lung cancer(... sel lung KAN-ser)

Stage I non-small cell lung cancer is divided into stages IA and IB. In stage IA, the tumor is in the lung only and is 3 centimeters or smaller.
.

Purpose

This randomized(RAN-duh-mized KLIH-nih-kul TRY-ul)

A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.
phase III trialA study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people. is studying different types of surgery to compare how well they work in treating patients with stage IA non-small cell lung cancer.

Objectives

Primary

  1. Compare the disease-free survival of patients with small (= 2 cm) peripheral stage IA non-small cell lung cancer undergoing lobectomy vs sublobar resection (wedge resection or segmentectomy).

Secondary

  1. Compare the overall survival of patients undergoing lobectomy vs sublobar resection.
  2. Compare the rates of loco-regional and systemic recurrence in patients undergoing lobectomy vs sublobar resection.
  3. Compare the pulmonary function of these patients, as measured by expiratory flow rates at 6 months postoperatively.
  4. Explore the relationship between characteristics of the primary lung cancer, as revealed by pre-operative CT scan and positron emission tomography (PET) imaging, and outcomes.
  5. Determine the false-negative rate of preoperative PET scan for identification of involved hilar and mediastinal lymph nodes.
  6. Assess the utility of annual follow-up CT scan after surgical resection in these patients.

Treatment Sites in Georgia


Emory University Hospital - Midtown
550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Study Coordinator:
Kim Baio
404-686-3343

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

Study Coordinator:
Kim Baio
404-686-3343

Doctors:

Daniel L. Miller MD