Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003831
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
1999-11-01
Brief Title:
Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000066988 | REGISTRY | NCI Physician Data Query | None |