Lymph Node Removal in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer - Full Text View

Sponsor:	American College of Surgeons
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003831

Purpose

RATIONALE: Surgical removal of all lymph nodes in the chest may kill cancer cells that have spread from tumors in the lung. It is not yet known whether complete removal of all lymph nodes in the chest is more effective than removal of selected lymph nodes in treating patients who have stage I or stage II non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of complete removal of all lymph nodes in the chest with that of selected removal of lymph nodes during lung cancer surgery in treating patients who have stage I or stage II non-small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Procedure: conventional surgery	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	Randomized Trial of Mediastinal Lymph Node Sampling Versus Complete Lymphadenectomy During Pulmonary Resection in the Patient With N0 and N1 (Less Than Hilar) Non-Small Cell Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	1000
Study Start Date:	July 1999

Detailed Description:

OBJECTIVES:

Compare whether a complete mediastinal lymph node dissection versus mediastinal lymph node sampling improves overall survival of patients with N0 or non-hilar N1 non-small cell lung cancer undergoing resection.
Compare these two methods with reference to identification of occult mediastinal lymph node involvement.
Compare the effect of these two methods on operative time and duration of postoperative complications, including chest tube drainage and length of hospitalization for these patients.
Compare the effect of these two methods on local recurrence free survival and local regional recurrence free survival of these patients.

OUTLINE: This is a randomized study.

Patients undergo lymph node sampling from multiple sites inside the chest. Patients with negative lymph nodes are randomized to 1 of 2 treatment arms.

Arm I (Mediastinal Lymph Node Sampling): No more lymph nodes are removed. Patients undergo pulmonary resection.
Arm II (Mediastinal Lymph Node Dissection): Patients undergo removal of nearly all of the lymph nodes from the central part of the chest between the lungs, followed by pulmonary resection.

Patients are followed at 4, 6, 8, 12, 18, 24, and 36 months and then annually thereafter until death.

PROJECTED ACCRUAL: A total of 1,000 patients (500 per arm) will be accrued for this study over 5 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Biopsy proven or suspected, clinically resectable stage I or II (T1 or T2, N0 or non-hilar N1, M0) non-small cell carcinoma of the lung (NSCLC)
- Squamous cell carcinoma, adenocarcinoma, or large cell carcinoma
If tissue diagnosis not established preoperatively, must be established intraoperatively prior to registration/randomization
If preoperative mediastinoscopy has been performed, hilar lymph nodes must be certified to be less than 1 cm in the short axis diameter by preoperative CT scan, and no N2 disease found at mediastinoscopy
If preoperative mediastinoscopy has not been performed, all lymph nodes in the hilum and mediastinum must measure less than 1 cm in the short axis diameter on preoperative CT scan
Candidate for complete resection via pneumonectomy, bilobectomy, lobectomy, or anatomic segmentectomy with or without sleeve resection
- Planned wedge resection only not eligible
All sampled nodes must be negative by frozen section assessment

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-2 OR
Zubrod 0-2

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

Medically fit for surgery
No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix, and deemed to be at low risk for recurrence from prior curatively treated malignancies

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy for NSCLC

Endocrine therapy:

Not specified

Radiotherapy:

No prior radiotherapy for NSCLC

Surgery:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003831

Show 74 Study Locations

Sponsors and Collaborators

American College of Surgeons

National Cancer Institute (NCI)

Investigators

Study Chair:

Mark S. Allen, MD

Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Allen MS, Darling GE, Decker PA, et al.: Number of lymph nodes harvested from a mediastinal lymphadenectomy: results of the randomized, prospective ACOSOG Z0030 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-7555, 398s, 2007.

Allen MS, Darling GE, Pechet TT, Mitchell JD, Herndon JE 2nd, Landreneau RJ, Inculet RI, Jones DR, Meyers BF, Harpole DH, Putnam JB Jr, Rusch VW; ACOSOG Z0030 Study Group. Morbidity and mortality of major pulmonary resections in patients with early-stage lung cancer: initial results of the randomized, prospective ACOSOG Z0030 trial. Ann Thorac Surg. 2006 Mar;81(3):1013-9; discussion 1019-20.

Potti A, Mukherjee S, Petersen R, Dressman HK, Bild A, Koontz J, Kratzke R, Watson MA, Kelley M, Ginsburg GS, West M, Harpole DH Jr, Nevins JR. A genomic strategy to refine prognosis in early-stage non-small-cell lung cancer. N Engl J Med. 2006 Aug 10;355(6):570-80. Erratum in: N Engl J Med. 2007 Jan 11;356(2):201-2.

Study ID Numbers:	CDR0000066988, ACOSOG-Z0030
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00003831 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I non-small cell lung cancer
stage II non-small cell lung cancer
squamous cell lung cancer
large cell lung cancer
adenocarcinoma of the lung

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on November 27, 2009