Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 1000 |
| Study Start Date: | July 1999 |
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 |
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
Show 74 Study Locations| Study Chair: | Mark S. Allen, MD | Mayo Clinic |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00003831 History of Changes |
| Other Study ID Numbers: | CDR0000066988, ACOSOG-Z0030 |
| Study First Received: | November 1, 1999 |
| Last Updated: | October 18, 2012 |
| 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:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013