Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Prognostic Study of Metastases in Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer That Can Be Removed by Surgery

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Diagnostic	Closed	18 and over	NCI	ACOSOG-Z0040 ACOSOG-Z0040, NCT00003901

Objectives

1. Determine the relationship between three indicators of occult metastases (cytological examination of pleural lavage, immunohistochemistry (IHC) assay of lymph nodes, and IHC assay of rib bone marrow) and survival of patients with resectable non-small cell lung cancer.
2. Determine the relationship between these indicators and conventional histology.
3. Model survival considering the indicators and other patient attributes that are of prime prognostic significance.
4. Determine the relationships between the indicators and the site of first recurrence in these patients.
5. Determine the prevalence of the indicators in these patients.
6. Determine the relationships between the indicators and disease free survival in these patients.

Entry Criteria

Disease Characteristics:

• Histologically proven stage I, IIA, IIB, or IIIA non-small cell lung cancer (NSCLC)
  • Histological confirmation may be preoperative or intraoperative
  • Clinically resectable disease
    • If preoperative mediastinoscopy performed, N1 or N2 disease eligible
  • Squamous cell, adenocarcinoma, or large cell



• Thoracotomy with intention of complete resection planned
  • Pneumonectomy, bilobectomy, lobectomy, or anatomic segmentectomy, with or without sleeve resection



• No pleural effusion

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for NSCLC
• Adjuvant chemotherapy allowed

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy for NSCLC
• Adjuvant radiotherapy allowed

Surgery:

• See Disease Characteristics
• At least 5 years since prior ipsilateral thoracotomy or thoracostomy

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

Pulmonary:

• See Disease Characteristics

Other:

• Medically fit for surgery
• No other malignancies within the past 5 years except curatively treated malignancies with low risk of recurrence

Expected Enrollment

A total of 1200 patients will be accrued for this study over 4 years.

Outline

All patients undergo complete lymph node sampling or dissection. A small portion of rib is removed at this time. Some patients may have primary tumor completely removed.

Lymph nodes and bone marrow from the rib section are examined for occult metastases using immunohistochemical staining methods and standard staining methods.

Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years.

Trial Contact Information

Trial Lead Organizations

American College of Surgeons Oncology Group

Robbin Cohen, MD, Protocol chair		Ph: 323-442-5849; 800-865-0102 Email: rcohen@usc.edu

Registry Information
Official Title		A Prospective Study of the Prognostic Significance of Occult Metastases in the Patient with Resectable Non-Small Cell Lung Carcinoma
Trial Start Date		1999-07-13
Registered in ClinicalTrials.gov		NCT00003901 1
Date Submitted to PDQ		1999-05-07
Information Last Verified		2004-10-18
NCI Grant/Contract Number		CA76001

Table of Links

1	http://clinicaltrials.gov/ct/show/NCT00003901