Trials / Completed
CompletedNCT00003831
Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,023 (actual)
- Sponsor
- Alliance for Clinical Trials in Oncology · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | conventional surgery |
Timeline
- Start date
- 1999-07-01
- Primary completion
- 2006-03-01
- Completion
- 2011-01-01
- First posted
- 2003-01-27
- Last updated
- 2016-07-14
Locations
74 sites across 3 countries: United States, Australia, Canada
Source: ClinicalTrials.gov record NCT00003831. Inclusion in this directory is not an endorsement.