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

Lung Cancer Clinical Trial

Official title:

Randomized Trial of Mediastinal Lymph Node Sampling Versus Complete Lymphadenectomy During Pulmonary Resection in the Patient With N0 and N1 (Less Than Hilar) Non-Small Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003831
• Other study ID #: ACOSOG-Z0030
• Secondary ID: CDR0000066988
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: July 12, 2016
• Start date: July 1999
• Est. completion date: January 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: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

• Compare whether a complete mediastinal lymph node dissection versus mediastinal lymph node sampling improves overall survival of patients with N0 or non-hilar N1 non-small cell lung cancer undergoing resection.

• Compare these two methods with reference to identification of occult mediastinal lymph node involvement.

• Compare the effect of these two methods on operative time and duration of postoperative complications, including chest tube drainage and length of hospitalization for these patients.

• Compare the effect of these two methods on local recurrence free survival and local regional recurrence free survival of these patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1023
• Est. completion date: January 2011
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

A patient will be eligible for inclusion in this study only if ALL of the following criteria apply:

Pre-operative:

1. Patient must be =18 years of age.

2. Patient must have an ECOG/Zubrod performance status of = 3.

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.

4. 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.

5. 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.

6. 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.

7. 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.

8. If patient is a survivor of a prior cancer, the following criteria are met:

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.

Intra-operative:

1. 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.

2. 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.

3. Any other suspicious mediastinal or hilar nodes must be sampled and proven negative by frozen section. Levels 2, 4 and 7 need not be re-sampled if they were sampled at a mediastinoscopy done within 60 days of thehoracotomy.

Exclusion Criteria:

A patient will NOT be eligible for inclusion in this study if ANY of the following criteria apply:

1. Patient has N2 disease determined at pre-operative mediastinoscopy or on sampling.

2. Patient has T3 or T4 tumor.

3. Patient is having only a wedge resection performed for treatment.

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• conventional surgery

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Centre	East Melbourne	Victoria
Australia	St. Vincent's Hospital	Fitzroy	Victoria
Canada	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Rhode Island Hospital	Boston	Massachusetts
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	Tri-Health Good Samaritan Hospital	Cincinnati	Ohio
United States	Veterans Affairs Medical Center - Cincinnati	Cincinnati	Ohio
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri
United States	Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital	Cooperstown	New York
United States	St. Luke's Hospital	Duluth	Minnesota
United States	Alexian Brothers Medical Center	Elk Grove Village	Illinois
United States	Englewood Hospital Oncology Program	Englewood	New Jersey
United States	Hurley Medical Center	Flint	Michigan
United States	Shands Cancer Center at the University of Florida	Gainesville	Florida
United States	Veterans Affairs Medical Center - Gainesville	Gainesville	Florida
United States	Westmoreland Regional Hospital	Greensburg	Pennsylvania
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Medical Center of Southwest Louisiana	Lafayette	Louisiana
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center	Los Angeles	California
United States	Jewish Hospital	Louisville	Kentucky
United States	Medical Center of Central Georgia	Macon	Georgia
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Loyola University Medical Center	Maywood	Illinois
United States	Holmes Regional Medical Center	Melbourne	Florida
United States	Jackson Memorial Hospital	Miami	Florida
United States	Veterans Affairs Medical Center - Minneapolis	Minneapolis	Minnesota
United States	Trinity Hospital	Minot	North Dakota
United States	Mobile Infirmary Medical Center	Mobile	Alabama
United States	West Virginia University Hospitals	Morgantown	West Virginia
United States	Edward Hospital Cancer Center	Naperville	Illinois
United States	Saint Thomas Hospital	Nashville	Tennessee
United States	Jameson Memorial Hospital	New Castle	Pennsylvania
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	New York Weill Cornell Cancer Center at Cornell University	New York	New York
United States	Creighton University School of Medicine	Omaha	Nebraska
United States	Veterans Affairs Medical Center - Omaha	Omaha	Nebraska
United States	Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center	Orange	California
United States	Huntington Cancer Center at Huntington Hospital	Pasadena	California
United States	Abramson Cancer Center at 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	Presbyterian-University Hospital	Pittsburgh	Pennsylvania
United States	St. Clair Memorial Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburg Medical Center - Shadyside Hospital	Pittsburgh	Pennsylvania
United States	UPMC St. Margaret	Pittsburgh	Pennsylvania
United States	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Earle A. Chiles Research Institute at Providence Portland Medical Center	Portland	Oregon
United States	Massey Cancer Center	Richmond	Virginia
United States	Valley Hospital	Ridgewood	New Jersey
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	William Beaumont Hospital - Royal Oak	Royal Oak	Michigan
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
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 of Washington Medical Center	Seattle	Washington
United States	Veterans Affairs Medical Center - Seattle	Seattle	Washington
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	St. John's Hospital	Springfield	Illinois
United States	Stanford University Medical Center	Stanford	California
United States	Long Island Cancer Center at Stony Brook University Hospital	Stony Brook	New York
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,  Australia,  Canada, 

References & Publications (6)

Allen MS, Darling GE, Decker PA, et al.: Number of lymph nodes harvested from a mediastinal lymphadenectomy: results of the randomized, prospective ACOSOG Z0030 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-7555, 398s, 2007.

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 — View Citation

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 Surgeon — View Citation

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 patien — View Citation

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 — View Citation

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. Erratum in: N Engl J Med. 2007 Jan 11;356(2):201-2. Retraction in: 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. N Engl J Med. 2011 Mar 24;364(12):1176. — 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