Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	NCI	ACOSOG-Z0030 ACOSOG-Z0030, NCT00003831

Objectives

1. 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.
2. Compare these two methods with reference to identification of occult mediastinal lymph node involvement.
3. 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.
4. Compare the effect of these two methods on local recurrence free survival and local regional recurrence free survival of these patients.

Entry Criteria

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

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

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

Expected Enrollment

A total of 1,000 patients (500 per arm) will be accrued for this study over 5 years.

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.

Allen MS, Darling GE, Decker PA, et al.: Number of lymph nodes harvested from a mediastinal lymphadenectomy: results of the randomized, prospective ACOSOG Z0030 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-7555, 398s, 2007.

Allen MS, Darling GE, Pechet TT, et al.: Morbidity and mortality of major pulmonary resections in patients with early-stage lung cancer: initial results of the randomized, prospective ACOSOG Z0030 trial. Ann Thorac Surg 81 (3): 1013-9; discussion 1019-20, 2006.[PUBMED Abstract]

Potti A, Mukherjee S, Petersen R, et al.: A genomic strategy to refine prognosis in early-stage non-small-cell lung cancer. N Engl J Med 355 (6): 570-80, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

American College of Surgeons Oncology Group

Mark Allen, MD, Protocol chair		Ph: 507-284-1517

Registry Information
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
Trial Start Date		1999-07-05
Registered in ClinicalTrials.gov		NCT00003831
Date Submitted to PDQ		1999-03-25
Information Last Verified		2003-07-30
NCI Grant/Contract Number		CA76001

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