Clinical trial NCT00003901: 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
Official title: A Prospective Study of the Prognostic Significance of Occult Metastases in the Patient With Resectable Non-Small Cell Lung Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer
Keywords: stage I non-small cell lung cancer
stage II non-small cell lung cancer
squamous cell lung cancer
large cell lung cancer
stage IIIA non-small cell lung cancer
adenocarcinoma of the lung
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 1310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival in Lymph Nodes Examined Patients
timeFrame: Up to 5 years
measure: Overall Survival in Bone Marrow Examined Patients
timeFrame: Up to 5 years
Secondary outcomes:
measure: Disease-Free Survival in Lymph Nodes Examined Patients
timeFrame: Up to 5 years
measure: Disease-Free Survival in Bone Marrow Examined Patients
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Providence Cancer Center
state: Alabama
city: Mobile
country: United States
facility: Mobile Infirmary Medical Center
state: Alabama
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center and Hospital
state: California
city: Pasadena
country: United States
facility: Huntington Cancer Center at Huntington Hospital
state: California
city: Sacramento
country: United States
facility: University of California Davis Cancer Center
state: California
city: San Francisco
country: United States
facility: UCSF Comprehensive Cancer Center
state: California
city: Denver
country: United States
facility: University of Colorado Health Sciences Center - Denver
state: Colorado
city: Fort Lauderdale
country: United States
facility: Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
state: Florida
city: Saint Petersburg
country: United States
facility: Bayfront Medical Center
state: Florida
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center
state: Illinois
city: Springfield
country: United States
facility: Cancer Institute at St. John's Hospital
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Iowa City
country: United States
facility: Holden Comprehensive Cancer Center at University of Iowa
state: Iowa
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: Flint
country: United States
facility: McLaren Regional Cancer Center
state: Michigan
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital - Royal Oak
state: Michigan
city: Saint Louis
country: United States
facility: Siteman Cancer Center
state: Missouri
city: Omaha
country: United States
facility: Veterans Affairs Medical Center - Omaha
state: Nebraska
city: Omaha
country: United States
facility: Creighton University School of Medicine
state: Nebraska
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Rochester
country: United States
facility: James P. Wilmot Cancer Center at University of Rochester Medical Center
state: New York
city: Stony Brook
country: United States
facility: Long Island Cancer Center at Stony Brook University Hospital
state: New York
city: Syracuse
country: United States
facility: University Hospital at State University of New York - Upstate Medical University
state: New York
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center at Wake Forest University
state: North Carolina
city: Cincinnati
country: United States
facility: Charles M. Barrett Cancer Center at University Hospital
state: Ohio
city: Cleveland
country: United States
facility: Ireland Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth's Cancer Care Center at MetroHealth Medical Center
state: Ohio
city: Portland
country: United States
facility: Providence Cancer Center at Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Cancer Institute at Oregon Health and Science University
state: Oregon
city: Greensburg
country: United States
facility: Westmoreland Regional Hospital
state: Pennsylvania
city: New Castle
country: United States
facility: Jameson Memorial Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Western Pennsylvania Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: St. Clair Memorial Hospital
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Cancer Center at Lankenau Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Saint Thomas Hospital
state: Tennessee
city: Nashville
country: United States
facility: Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
state: Tennessee
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
city: Murray
country: United States
facility: Cottonwood Hospital Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
city: Charlottesville
country: United States
facility: Cancer Center at the University of Virginia
state: Virginia
city: Seattle
country: United States
facility: Veterans Affairs Medical Center - Seattle
state: Washington
city: Seattle
country: United States
facility: Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
state: Washington
city: Seattle
country: United States
facility: University Cancer Center at University of Washington Medical Center
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Hospitals
state: West Virginia
city: Madison
country: United States
facility: University of Wisconsin Comprehensive Cancer Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Cancer Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Veterans Affairs Medical Center - Milwaukee (Zablocki)
state: Wisconsin
city: London
country: Canada
facility: Cancer Care Ontario-London Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University of Southern California
name: Robbin G. Cohen, MD
role: STUDY_CHAIR
References:
citation: 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: report of the ACOSOG Z0040 trial. J Clin Oncol. 2011 Nov 10;29(32):4313-9. doi: 10.1200/JCO.2011.35.2500. Epub 2011 Oct 11.