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Lung CancerPhase 3NCT00003831

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

A Phase 3 study testing conventional surgery in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 74 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
conventional surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,023 participants
Where
74 sitesin 3 countries
Study dates
Jul 1999to Jan 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A patient will be eligible for inclusion in this study only if ALL of the following criteria apply:
  • 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.
Show all 17Show fewer
  • 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.
  • 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.

Who cannot join

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

Trial locations and contacts

74 sites in 3 countries.

74 sites in 3 countries

United States70 sites

  • Emory University School of Medicine

    Atlanta, Georgia, 30322

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114-2620

  • Rhode Island Hospital

    Boston, Massachusetts, 02114-2620

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Cancer Center at the University of Virginia

    Charlottesville, Virginia, 22908

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Veterans Affairs Medical Center - Cincinnati

    Cincinnati, Ohio, 45220-2288

  • Tri-Health Good Samaritan Hospital

    Cincinnati, Ohio, 45220

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267-0558

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • St. Luke's Hospital

    Duluth, Minnesota, 55805-2193

  • Alexian Brothers Medical Center

    Elk Grove Village, Illinois, 60007

  • Englewood Hospital Oncology Program

    Englewood, New Jersey, 07631

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Veterans Affairs Medical Center - Gainesville

    Gainesville, Florida, 32608-1197

  • Shands Cancer Center at the University of Florida

    Gainesville, Florida, 32610-0342

  • Westmoreland Regional Hospital

    Greensburg, Pennsylvania, 15601-2282

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Medical Center of Southwest Louisiana

    Lafayette, Louisiana, 70506

  • Central Baptist Hospital

    Lexington, Kentucky, 40503

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

    Los Angeles, California, 90048

  • Jewish Hospital

    Louisville, Kentucky, 40202-1886

  • Medical Center of Central Georgia

    Macon, Georgia, 31201

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-7375

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Holmes Regional Medical Center

    Melbourne, Florida, 32901

  • Jackson Memorial Hospital

    Miami, Florida, 33136

  • Veterans Affairs Medical Center - Minneapolis

    Minneapolis, Minnesota, 55417

  • Trinity Hospital

    Minot, North Dakota, 58701

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36640-0460

  • West Virginia University Hospitals

    Morgantown, West Virginia, 26506-9300

  • Edward Hospital Cancer Center

    Naperville, Illinois, 60540

  • Saint Thomas Hospital

    Nashville, Tennessee, 37205

  • Jameson Memorial Hospital

    New Castle, Pennsylvania, 16105

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • New York Weill Cornell Cancer Center at Cornell University

    New York, New York, 10021

  • Veterans Affairs Medical Center - Omaha

    Omaha, Nebraska, 68105

  • Creighton University School of Medicine

    Omaha, Nebraska, 68131

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

    Orange, California, 92868

  • Huntington Cancer Center at Huntington Hospital

    Pasadena, California, 91105

  • Abramson Cancer Center at University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104-4283

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111-2497

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212-4772

  • University of Pittsburg Medical Center - Shadyside Hospital

    Pittsburgh, Pennsylvania, 15213-2582

  • Presbyterian-University Hospital

    Pittsburgh, Pennsylvania, 15213

  • UPMC St. Margaret

    Pittsburgh, Pennsylvania, 15215

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • St. Clair Memorial Hospital

    Pittsburgh, Pennsylvania, 15243-1899

  • Earle A. Chiles Research Institute at Providence Portland Medical Center

    Portland, Oregon, 97213-2967

  • Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Valley Hospital

    Ridgewood, New Jersey, 07450

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

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

    Rochester, New York, 14642

  • William Beaumont Hospital - Royal Oak

    Royal Oak, Michigan, 48073

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94143-0128

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98104

  • University of Washington Medical Center

    Seattle, Washington, 98195-6310

  • Veterans Affairs Medical Center - Seattle

    Seattle, Washington, 98195-6310

  • St. John's Hospital

    Springfield, Illinois, 62701

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Stanford University Medical Center

    Stanford, California, 94305-5408

  • Long Island Cancer Center at Stony Brook University Hospital

    Stony Brook, New York, 11790-8191

  • Lankenau Cancer Center at Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

Other trials in United States

Australia2 sites

  • Peter MacCallum Cancer Centre

    East Melbourne, Victoria, 3002

  • St. Vincent's Hospital

    Fitzroy, Victoria, 3065

Other trials in Australia

Canada2 sites

  • Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

Other trials in Canada

About this study

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

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.

Read the detailed 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.
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
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00003831
Study groupRoleWhat they receive
Lymph node samplingExperimentalPatients 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.
Receives: Procedure: conventional surgery
Lymph node dissectionActive comparatorPatients 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.
Receives: Procedure: conventional surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Measured: Up to 5 years

Secondary outcomes (1)

  1. Disease-free survival

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJul 1999
  3. Primary completionMar 2006
  4. Study completionJan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,023 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003831
Sponsor's protocol ID
ACOSOG-Z0030
Other IDs
CDR0000066988
Status last verified
Jul 2016
First submitted
1 Nov 1999
Last updated
14 Jul 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 16899777

  • 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.

    PubMed 23040416

  • 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.

    PubMed 20829340

  • 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.

    PubMed 21335122

  • 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.

    PubMed 16488712

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing conventional surgery in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 74 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003831, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2016.

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