Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed18 and overNCI, OtherCDR0000066988
ACOSOG-Z0030, NCT00003831

Trial Description


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.

Further Study Information


  • 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 Criteria


  • 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



  • 18 and over

Performance status:

  • ECOG 0-2 OR
  • Zubrod 0-2

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • 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


Biologic therapy:

  • Not specified


  • No prior chemotherapy for NSCLC

Endocrine therapy:

  • Not specified


  • No prior radiotherapy for NSCLC


  • See Disease Characteristics

Trial Contact Information

Trial Lead Organizations/Sponsors

American College of Surgeons

  • National Cancer Institute
Mark S. Allen, Study Chair

Link to the current record.
NLM Identifier NCT00003831 processed this data on April 09, 2015

Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to