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Home > "P" Clinical Trials Conditions > 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

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



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

For Condition: adenocarcinoma of the lung,large cell lung cancer,stage 2 non-small cell lung cancer,stage 3A non-small cell lung cancer,stage 1 non-small cell lung cancer,squamous cell lung cancer
Status: Recruiting
Sponsor(s): American College of Surgeons , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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. 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. PROJECTED ACCRUAL: A total of 1200 patients will be accrued for this study over 4 years.
Eligibility:
Study Type:
  Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol 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 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 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
RobbinCohen,  Study Chair,  University of Southern California, Healthcare Consultation Center

Veterans Affairs Medical Center - Seattle *Recruiting*
Seattle,  Washington,  98108
United States
Recruiting Douglas  Wood 206-685-3228

USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles,  California,  90033-0804
United States
Recruiting Robbin  Cohen 323-865-3000

Mobile Infirmary Medical Center *Recruiting*
Mobile,  Alabama,  36640-0460
United States
Recruiting Gaylord  Walker 251-435-2400

Western Pennsylvania Hospital *Recruiting*
Pittsburgh,  Pennsylvania,  15224
United States
Recruiting Robert  Keenan 412-359-6202

UCSF Comprehensive Cancer Center *Recruiting*
San Francisco,  California,  94115
United States
Recruiting David  Jablons 415-885-3882

McLaren Regional Cancer Center *Recruiting*
Flint,  Michigan,  48432
United States
Recruiting Joyce  Strohl 810-732-8322

University of California Davis Cancer Center *Recruiting*
Sacramento,  California,  95817
United States
Recruiting Richard  Bold 916-734-7269

University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison,  Wisconsin,  53792-7375
United States
Recruiting John  Niederhuber 608-265-5212

University of Texas - MD Anderson Cancer Center *Recruiting*
Houston,  Texas,  77030-4009
United States
Recruiting Raphael  Pollock 713-792-6928

Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital *Recruiting*
Ft. Lauderdale,  Florida,  33308
United States
Recruiting Leonard  Seigel 954-267-7700

Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City,  New York,  10021
United States
Recruiting Valerie  Rusch 212-639-5873

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus *Recruiting*
Seattle,  Washington,  98104
United States
Recruiting Ralph  Aye 206-682-4790

West Virginia University Hospitals *Recruiting*
Morgantown,  West Virginia,  26506-9300
United States
Recruiting Geoffrey  Graeber 304-293-4180

Veterans Affairs Medical Center - Omaha *Recruiting*
Omaha,  Nebraska,  68105
United States
Recruiting Robert  Fitzgibbons 402-280-4503

Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee,  Wisconsin,  53226
United States
Recruiting Mario  Gasparri 414-805-4450

Fox Chase Cancer Center *Recruiting*
Philadelphia,  Pennsylvania,  19111-2497
United States
Recruiting Elin  Sigurdson 215-728-3519

Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus *Recruiting*
Nashville,  Tennessee,  37212
United States
Recruiting John  Roberts 615-327-4751

Alexian Brothers Medical Center *Recruiting*
Elk Grove Village,  Illinois,  60007
United States
Recruiting Thomas  Hinkamp 847-981-6087

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville,  Tennessee,  37232-6838
United States
Recruiting John  Roberts 615-936-1782

Hurley Medical Center *Recruiting*
Flint,  Michigan,  48503
United States
Recruiting Joyce  Strohl 810-732-8322

Providence Cancer Center at Providence Portland Medical Center *Recruiting*
Portland,  Oregon,  97213-2967
United States
Recruiting John  Handy 503-215-2300

University Hospital at State University of New York - Upstate Medical University *Recruiting*
Syracuse,  New York,  13210
United States
Recruiting Leslie  Kohman 315-464-6321

University Cancer Center at University of Washington Medical Center *Recruiting*
Seattle,  Washington,  98195-6310
United States
Recruiting Douglas  Wood 206-685-3228

Westmoreland Regional Hospital *Recruiting*
Greensburg,  Pennsylvania,  15601-2282
United States
Recruiting Rodney  Landreneau 412-359-6412

William Beaumont Hospital - Royal Oak *Recruiting*
Royal Oak,  Michigan,  48073
United States
Recruiting Gary  Chmielewski 248-551-0669

Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia,  Pennsylvania,  19104-4283
United States
Recruiting Douglas  Fraker 215-662-7866

Bayfront Medical Center *Recruiting*
Saint Petersburg,  Florida,  33701
United States
Recruiting Robert  Reichert 727-821-1221

Barnes-Jewish Hospital *Recruiting*
St. Louis,  Missouri,  63110
United States
Recruiting Bryan  Meyers 314-362-8598

Jewish Hospital *Recruiting*
Louisville,  Kentucky,  40202-1886
United States
Recruiting Roy  Bowling 502-589-3173

St. John's Hospital *Recruiting*
Springfield,  Illinois,  62701
United States
Recruiting Stephen  Hazelrigg 217-545-8875

Creighton University School of Medicine *Recruiting*
Omaha,  Nebraska,  68131
United States
Recruiting Robert  Fitzgibbons 402-280-4503

Providence Hospital - Mobile AL *Recruiting*
Mobile,  Alabama,  36685
United States
Recruiting Gaylord  Walker 251-433-5557

Roswell Park Cancer Institute *Recruiting*
Buffalo,  New York,  14263-0001
United States
Recruiting Timothy  Anderson 716-845-5873

Veterans Affairs Medical Center - Milwaukee (Zablocki) *Recruiting*
Milwaukee,  Wisconsin,  53295
United States
Recruiting Mario  Gasparri 414-456-6904

Lankenau Cancer Center at Lankenau Hospital *Recruiting*
Wynnewood,  Pennsylvania,  19096
United States
Recruiting Ned  Carp 610-642-1908

Long Island Cancer Center at Stony Brook University Hospital *Recruiting*
Stony Brook,  New York,  11790-8191
United States
Recruiting Thomas  Bilfinger 631-444-1820

Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City,  Iowa,  52242-1062
United States
Recruiting Kemp  Kernstine 319-356-3407

Jameson Memorial Hospital *Recruiting*
New Castle,  Pennsylvania,  16105
United States
Recruiting Robert  Keenan 412-359-6202

Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem,  North Carolina,  27157-1082
United States
Recruiting Edward  Levine 336-716-4276

MetroHealth Medical Center *Recruiting*
Cleveland,  Ohio,  44109
United States
Recruiting Bruce  Averbook 216-778-4795

Toronto General Hospital *Recruiting*
Toronto,  Ontario,  M5G 2C4
Canada
Recruiting Gail  Darling 416-340-3121

Ireland Cancer Center *Recruiting*
Cleveland,  Ohio,  44106-5065
United States
Recruiting Bruce  Averbook 216-778-4795

Cancer Institute at Oregon Health and Science University *Recruiting*
Portland,  Oregon,  97239
United States
Recruiting Kevin  Billingsley 503-494-5501

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia *Recruiting*
Philadelphia,  Pennsylvania,  19107-5541
United States
Recruiting Ronald  Weigel 215-955-0526

Cancer Care Ontario-London Regional Cancer Centre *Recruiting*
London,  Ontario,  N6A 4L6
Canada
Recruiting Richard  Inculet 519-667-6679

St. Clair Memorial Hospital *Recruiting*
Pittsburgh,  Pennsylvania,  15243-1899
United States
Recruiting Rodney  Landreneau 412-359-6412

University of Colorado Health Sciences Center - Denver *Recruiting*
Denver,  Colorado,  80262
United States
Recruiting John  Mitchell 303-315-4556

Huntington Cancer Center at Huntington Hospital *Recruiting*
Pasadena,  California,  91105
United States
Recruiting Robbin  Cohen 323-442-5850

Southern Illinois University School of Medicine *Recruiting*
Springfield,  Illinois,  62702
United States
Recruiting Stephen  Hazelrigg 217-545-8875

Saint Thomas Hospital *Recruiting*
Nashville,  Tennessee,  37205
United States
Recruiting Jonathan  Nesbitt 615-385-4781

LDS Hospital *Recruiting*
Salt Lake City,  Utah,  84143
United States
Recruiting Michael  Collins 801-321-2260

University of Chicago Cancer Research Center *Recruiting*
Chicago,  Illinois,  60637-1470
United States
Recruiting Mark  Ferguson 773-702-3551

Cottonwood Hospital Medical Center *Recruiting*
Murray,  Utah,  84107
United States
Recruiting Michael  Collins 801-321-2260

Cancer Center at the University of Virginia *Recruiting*
Charlottesville,  Virginia,  22908
United States
Recruiting David  Jones 434-243-6443

Allegheny General Hospital *Recruiting*
Pittsburgh,  Pennsylvania,  15212-4772
United States
Recruiting Robert  Keenan 412-359-6202

James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester,  New York,  14642
United States
Recruiting David  Johnstone 585-275-1509

Temple University Hospital *Recruiting*
Philadelphia,  Pennsylvania,  19140
United States
Recruiting Arun  Singhal 215-707-2685

Charles M. Barrett Cancer Center at University Hospital *Recruiting*
Cincinnati,  Ohio,  45267-0558
United States
Recruiting John  Howington 513-584-1391


Additional Information:
Study ID Numbers:
  CDR0000067072;  ACOSOG-Z0040
Study Start Date: 
Record last reviewed: November 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003901

Other Stage 2 Non-Small Cell Lung Cancer Studies:
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2. Chemotherapy and Radiation Therapy With or Without Efaproxiral in Treating Patients With Stage III Non-Small Cell Lung Cancer

3. Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer

4. Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer

5. Chemotherapy Followed by Surgery or Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer

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