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

Lung Cancer Clinical Trial

Official title:

A Prospective Study of the Prognostic Significance of Occult Metastases in the Patient With Resectable Non-Small Cell Lung Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003901
• Other study ID #: ACOSOG-Z0040
• Secondary ID: CDR0000067072
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: July 12, 2016
• Start date: July 1999
• Est. completion date: October 2011

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Prognostic testing for early signs of metastases may help doctors detect metastases early and plan more effective treatment.

PURPOSE: Phase III trial to study the relationship between early signs of metastases and survival in patients who have stage I, stage II, or stage III non-small cell lung cancer that can be removed by surgery.

Description:

OBJECTIVES:

• 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.

• Determine the relationship between these indicators and conventional histology.

• Model survival considering the indicators and other patient attributes that are of prime prognostic significance.

• Determine the relationships between the indicators and the site of first recurrence in these patients.

• Determine the prevalence of the indicators in these patients.

• Determine the relationships between the indicators and disease free survival in these patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1310
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient must be = 18 years old.

2. Patient must have ECOG/Zubrod status < 3.

3. Patient must have clinically resectable, NSCLC (squamous cell, adenocarcinoma, or large cell) and be clinical Stage I, IIa, IIb or IIIa, according to the 1998 staging system of the American Joint Commission on Cancer for lung cancer.

4. Patient must have N1 or N2 disease. NOTE: Patient must undergo mediastinoscopy if preoperative studies suggest N3 disease.

5. Patient must have a pathologic diagnosis (pre-operative or intra-operative) of NSCLC prior to registration.

6. Patient must be anticipated to have a thoracotomy with the intention of a curative resection for primary NSCLC. NOTE: The preoperative assessment of resectability should, at a minimum, include a CT scan of the chest and upper abdomen, including the adrenal glands, within 60 days prior to registration.

7. Patient must be medically fit for surgery.

8. Patient must be a candidate for complete resection of the carcinoma via pneumonectomy, bilobectomy, lobectomy, or anatomic segmentectomy with or without sleeve resection.

9. Patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study-related procedures.

10. Patient must be available for follow-up.

11. If the patient is a survivor of a prior cancer, all of the following criteria must apply:

1. Patient has undergone potentially curative therapy for all prior malignancies,

2. No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone),

3. Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.

Exclusion Criteria:

1. Patient has evidence of pleural effusion by physical assessment, lateral chest x-ray, or by chest CT scan.

2. Patient has had ipsilateral thoracotomy or thoracoscopy within the past 5 years.

3. Patient has received prior chemotherapy or radiotherapy for this cancer.

4. Patient is considered a poor surgical risk due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.

5. Patient for whom the surgeon plans to perform only a wedge resection for treatment.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• immunohistochemistry staining method

Procedure:
• biopsy

• surgery

Locations

Country	Name	City	State
Canada	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Cancer Center at the University of Virginia	Charlottesville	Virginia
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	Ireland Cancer Center	Cleveland	Ohio
United States	MetroHealth's Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio
United States	University of Colorado Health Sciences Center - Denver	Denver	Colorado
United States	Alexian Brothers Medical Center	Elk Grove Village	Illinois
United States	Hurley Medical Center	Flint	Michigan
United States	McLaren Regional Cancer Center	Flint	Michigan
United States	Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital	Fort Lauderdale	Florida
United States	Westmoreland Regional Hospital	Greensburg	Pennsylvania
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	Jewish Hospital	Louisville	Kentucky
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	Veterans Affairs Medical Center - Milwaukee (Zablocki)	Milwaukee	Wisconsin
United States	Mobile Infirmary Medical Center	Mobile	Alabama
United States	Providence Cancer Center	Mobile	Alabama
United States	West Virginia University Hospitals	Morgantown	West Virginia
United States	Cottonwood Hospital Medical Center	Murray	Utah
United States	Saint Thomas Hospital	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center	Nashville	Tennessee
United States	Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus	Nashville	Tennessee
United States	Jameson Memorial Hospital	New Castle	Pennsylvania
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Creighton University School of Medicine	Omaha	Nebraska
United States	Veterans Affairs Medical Center - Omaha	Omaha	Nebraska
United States	Huntington Cancer Center at Huntington Hospital	Pasadena	California
United States	Abramson Cancer Center of the University of Pennsylvania Medical Center	Philadelphia	Pennsylvania
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	St. Clair Memorial Hospital	Pittsburgh	Pennsylvania
United States	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Cancer Institute at Oregon Health and Science University	Portland	Oregon
United States	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York
United States	William Beaumont Hospital - Royal Oak	Royal Oak	Michigan
United States	University of California Davis Cancer Center	Sacramento	California
United States	Siteman Cancer Center	Saint Louis	Missouri
United States	Bayfront Medical Center	Saint Petersburg	Florida
United States	LDS Hospital	Salt Lake City	Utah
United States	UCSF Comprehensive Cancer Center	San Francisco	California
United States	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington
United States	University Cancer Center at University of Washington Medical Center	Seattle	Washington
United States	Veterans Affairs Medical Center - Seattle	Seattle	Washington
United States	Cancer Institute at St. John's Hospital	Springfield	Illinois
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	Long Island Cancer Center at Stony Brook University Hospital	Stony Brook	New York
United States	University Hospital at State University of New York - Upstate Medical University	Syracuse	New York
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina
United States	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Rusch VW, Hawes D, Decker PA, Martin SE, Abati A, Landreneau RJ, Patterson GA, Inculet RI, Jones DR, Malthaner RA, Cohen RG, Ballman K, Putnam JB Jr, Cote RJ. Occult metastases in lymph nodes predict survival in resectable non-small-cell lung cancer: repo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		Up to 5 years	No
Secondary	disease-free survival		Up to 5 years	No