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

NCT00003831 | Completed Phase 3 DMC

• 2 other identifiers: ACOSOG-Z0030CDR0000066988
• Study Type: interventional
• Target: 1,023
• Locations: 3 countries
• Sites: 74

Brief Summary

RATIONALE: Surgical removal of all lymph nodes in the chest may kill cancer cells that have spread from tumors in the lung. It is not yet known whether complete removal of all lymph nodes in the chest is more effective than removal of selected lymph nodes in treating patients who have stage I or stage II non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of complete removal of all lymph nodes in the chest with that of selected removal of lymph nodes during lung cancer surgery in treating patients who have stage I or stage II non-small cell lung cancer.

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; adenocarcinoma of the lung

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Up to 5 years

Secondary Outcomes (1)

• Disease-free survival

  Up to 5 years

Study Arms (2)

Lymph node sampling

EXPERIMENTAL

Patients undergo pulmonary resection. No additional lymph nodes are removed. Patients are followed at 4, 6, 8, 12, 18, 24, and 36 months and then annually thereafter until death.

Procedure: conventional surgery

Lymph node dissection

ACTIVE COMPARATOR

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.

Procedure: conventional surgery

Interventions

conventional surgery PROCEDURE

Lymph node dissection; Lymph node sampling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pre-operative:
• Patient must be ≥18 years of age.
• Patient must have an ECOG/Zubrod performance status of ≤ 3.
• Patient must have tissue diagnosis of a clinically resectable T1 or T2, N0 or non-hilar N1, M0 NSCLC (squamous cell carcinoma, large cell carcinoma or adenocarcinoma including bronchoalveolar carcinoma) established prior to randomization. NOTE: A patient without a pre-operative tissue diagnosis, but with clinically suspected NSCLC that fits the above criteria is eligible provided the tissue diagnosis is confirmed intraoperatively.
• Patient must have pre-operative imaging procedure, CT scan of the chest and upper abdomen to include liver and adrenal glands to determine eligibility, within 60 days of the date of the pulmonary resection.
• Patient that has not had a mediastinoscopy should have no mediastinal adenopathy on the CT of the chest defined as no lymph node \> 1 cm in the shortest axis.
• Patient is a candidate for a complete resection of the carcinoma via pneumonectomy,lobectomy, bilobectomy, or anatomic segmentectomy with or without sleeve resection,as noted in the surgical plan.
• Patient, or patient's legally acceptable representative, must provide a signed and dated Z0030-specific written informed consent prior to registration and any study-related procedures.
• If patient is a survivor of a prior cancer, the following criteria are met:
• Patient has undergone potentially curative therapy for all prior malignancies,
• 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),
• Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.
• Intra-operative:
• Patient with right-sided lesions must have at least nodal stations #2R, 4R, 7 and 10 R examined. If the nodes are found, they must be sampled and proven negative by frozen section.
• Patient with left-sided lesions must have at least nodal stations #5, 6, 7 and 10L examined. If the nodes are found, they must be sampled and proven negative by frozen section.

You may not qualify if:

• Patient has N2 disease determined at pre-operative mediastinoscopy or on sampling.
• Patient has T3 or T4 tumor.
• Patient is having only a wedge resection performed for treatment.
• Patient has received prior chemotherapy or radiotherapy for this cancer.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (74)

Mobile Infirmary Medical Center

Mobile, Alabama, 36640-0460, United States

Location

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center

Orange, California, 92868, United States

Location

Huntington Cancer Center at Huntington Hospital

Pasadena, California, 91105, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94143-0128, United States

Location

Stanford University Medical Center

Stanford, California, 94305-5408, United States

Location

Veterans Affairs Medical Center - Gainesville

Gainesville, Florida, 32608-1197, United States

Location

Shands Cancer Center at the University of Florida

Gainesville, Florida, 32610-0342, United States

Location

Holmes Regional Medical Center

Melbourne, Florida, 32901, United States

Location

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Medical Center of Central Georgia

Macon, Georgia, 31201, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Alexian Brothers Medical Center

Elk Grove Village, Illinois, 60007, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Edward Hospital Cancer Center

Naperville, Illinois, 60540, United States

Location

St. John's Hospital

Springfield, Illinois, 62701, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Jewish Hospital

Louisville, Kentucky, 40202-1886, United States

Location

Medical Center of Southwest Louisiana

Lafayette, Louisiana, 70506, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114-2620, United States

Location

Rhode Island Hospital

Boston, Massachusetts, 02114-2620, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

William Beaumont Hospital - Royal Oak

Royal Oak, Michigan, 48073, United States

Location

St. Luke's Hospital

Duluth, Minnesota, 55805-2193, United States

Location

Veterans Affairs Medical Center - Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Veterans Affairs Medical Center - Omaha

Omaha, Nebraska, 68105, United States

Location

Creighton University School of Medicine

Omaha, Nebraska, 68131, United States

Location

Englewood Hospital Oncology Program

Englewood, New Jersey, 07631, United States

Location

Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital

Cooperstown, New York, 13326, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Long Island Cancer Center at Stony Brook University Hospital

Stony Brook, New York, 11790-8191, United States

Location

Trinity Hospital

Minot, North Dakota, 58701, United States

Location

Veterans Affairs Medical Center - Cincinnati

Cincinnati, Ohio, 45220-2288, United States

Location

Tri-Health Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267-0558, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Earle A. Chiles Research Institute at Providence Portland Medical Center

Portland, Oregon, 97213-2967, United States

Location

Westmoreland Regional Hospital

Greensburg, Pennsylvania, 15601-2282, United States

Location

Jameson Memorial Hospital

New Castle, Pennsylvania, 16105, United States

Location

Abramson Cancer Center at University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212-4772, United States

Location

University of Pittsburg Medical Center - Shadyside Hospital

Pittsburgh, Pennsylvania, 15213-2582, United States

Location

Presbyterian-University Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC St. Margaret

Pittsburgh, Pennsylvania, 15215, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

St. Clair Memorial Hospital

Pittsburgh, Pennsylvania, 15243-1899, United States

Location

Lankenau Cancer Center at Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States

Location

Saint Thomas Hospital

Nashville, Tennessee, 37205, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Cancer Center at the University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, 98104, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195-6310, United States

Location

Veterans Affairs Medical Center - Seattle

Seattle, Washington, 98195-6310, United States

Location

West Virginia University Hospitals

Morgantown, West Virginia, 26506-9300, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-7375, United States

Location

Peter MacCallum Cancer Centre

East Melbourne, Victoria, 3002, Australia

Location

St. Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (5)

• Potti A, Mukherjee S, Petersen R, Dressman HK, Bild A, Koontz J, Kratzke R, Watson MA, Kelley M, Ginsburg GS, West M, Harpole DH Jr, Nevins JR. A genomic strategy to refine prognosis in early-stage non-small-cell lung cancer. N Engl J Med. 2006 Aug 10;355(6):570-80. doi: 10.1056/NEJMoa060467.

  PMID: 16899777 BACKGROUND

• Fibla JJ, Cassivi SD, Brunelli A, Decker PA, Allen MS, Darling GE, Landreneau RJ, Putnam JB. Re-evaluation of the prognostic value of visceral pleura invasion in Stage IB non-small cell lung cancer using the prospective multicenter ACOSOG Z0030 trial data set. Lung Cancer. 2012 Dec;78(3):259-62. doi: 10.1016/j.lungcan.2012.09.010. Epub 2012 Oct 3.

  PMID: 23040416 RESULT

• Darling GE, Allen MS, Decker PA, Ballman K, Malthaner RA, Inculet RI, Jones DR, McKenna RJ, Landreneau RJ, Putnam JB Jr. Number of lymph nodes harvested from a mediastinal lymphadenectomy: results of the randomized, prospective American College of Surgeons Oncology Group Z0030 trial. Chest. 2011 May;139(5):1124-1129. doi: 10.1378/chest.10-0859. Epub 2010 Sep 9.

  PMID: 20829340 RESULT

• Darling GE, Allen MS, Decker PA, Ballman K, Malthaner RA, Inculet RI, Jones DR, McKenna RJ, Landreneau RJ, Rusch VW, Putnam JB Jr. Randomized trial of mediastinal lymph node sampling versus complete lymphadenectomy during pulmonary resection in the patient with N0 or N1 (less than hilar) non-small cell carcinoma: results of the American College of Surgery Oncology Group Z0030 Trial. J Thorac Cardiovasc Surg. 2011 Mar;141(3):662-70. doi: 10.1016/j.jtcvs.2010.11.008.

  PMID: 21335122 RESULT

• Allen MS, Darling GE, Pechet TT, Mitchell JD, Herndon JE 2nd, Landreneau RJ, Inculet RI, Jones DR, Meyers BF, Harpole DH, Putnam JB Jr, Rusch VW; ACOSOG Z0030 Study Group. 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. 2006 Mar;81(3):1013-9; discussion 1019-20. doi: 10.1016/j.athoracsur.2005.06.066.

  PMID: 16488712 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Mark S. Allen, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: July 1, 1999
• Primary Completion: March 1, 2006
• Study Completion: January 1, 2011
• Last Updated: July 14, 2016

Record last verified: 2016-07

Locations

US (70); CA (2); AU (2)