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Clinical Trials (PDQ®)

Phase III Randomized Comparison of Lobectomy vs Limited Pulmonary Resection for T1 N0 non-Small Cell Lung Carcinoma (Summary Last Modified 11/88)

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosedany ageLCSG-821
LCSG-8101

Objectives

I.  Determine whether limited pulmonary resection (segmental or wedge 
resection) affords the same potential for cure as standard lobectomy in 
patients with T1 N0 non-small cell carcinoma of the lung.
II.  Determine whether limited resection is comparable to lobectomy with 
reference to in-hospital mortality and morbidity.
III.  Determine whether limited pulmonary resection maintains better pulmonary 
function and reserve than lobectomy.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients of any age with presumed 
non-small cell carcinoma of the lung in whom the segmental bronchial orifice 
contains no carcinoma at bronchoscopy.  The surgical stage must be T1 N0 M0 
and the tumor must be amenable to complete surgical removal.  There may be no 
segmental lymph nodes involved with tumor.  There may be no history of renal 
cell carcinoma, melanoma, breast cancer, or GI cancer.  There may be no 
history of any other cancer, except nonmelanomatous skin cancer or in situ 
carcinoma of the cervix, unless there is a 5-year disease-free interval since 
last therapy.

Expected Enrollment

215 eligible patients will be entered over 3.6 years.  As of October, 1988, 
the accrual goal has been increased to 240 eligible patients; it is estimated 
that a total accrual of 275 patients will be required to achieve this goal.

Outline

Randomized study.
Arm I:  Surgery.  Lobectomy.
Arm II:  Surgery.  Limited Resection.

Published Results

Ginsberg RJ, Rubinstein LV: Randomized trial of lobectomy versus limited resection for T1 N0 non-small cell lung cancer. Lung Cancer Study Group. Ann Thorac Surg 60 (3): 615-22; discussion 622-3, 1995.[PUBMED Abstract]

Ginsberg RJ, Rubinstein L: The comparison of limited resection to lobectomy for T1N0 non-small cell lung cancer. LCSG 821. Chest 106 (6 Suppl): 318S-319S, 1994.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Lung Cancer Study Group

Robert J. Ginsberg, MD, FRCSC, Protocol chair (Contact information may not be current)
Ph: 416-340-4730

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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