Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00003831|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 14, 2016
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 or disease||Intervention/treatment||Phase|
|Lung Cancer||Procedure: conventional surgery||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1023 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 1999|
|Actual Primary Completion Date :||March 2006|
|Actual Study Completion Date :||January 2011|
Experimental: Lymph node sampling
Patients undergo pulmonary resection. No additional lymph nodes are removed. Patients are followed at 4, 6, 8, 12, 18, 24, and 36 months and then annually thereafter until death.
Procedure: conventional surgery
Active Comparator: 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.
Procedure: conventional surgery
- Overall survival [ Time Frame: Up to 5 years ]
- Disease-free survival [ Time Frame: Up to 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003831
|Study Chair:||Mark S. Allen, MD||Mayo Clinic|