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NCT00003831 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2016-07-14

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
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.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Procedure: conventional surgery
    label
    Lymph node sampling
    type
    EXPERIMENTAL
  2. description
    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.
    intervention Names
    1. Procedure: conventional surgery
    label
    Lymph node dissection
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Lymph node dissection
    2. Lymph node sampling
    name
    conventional surgery
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
1023
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Overall survival
    time Frame
    Up to 5 years
secondary Outcomes
  1. measure
    Disease-free survival
    time Frame
    Up to 5 years
Full study description
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.
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.
Source references
references
  1. 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. doi: 10.1056/NEJMoa060467.
    pmid
    16899777
    retractions
    1. pmid
      21366430
      source
      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
    type
    BACKGROUND
  2. 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 set. Lung Cancer. 2012 Dec;78(3):259-62. doi: 10.1016/j.lungcan.2012.09.010. Epub 2012 Oct 3.
    pmid
    23040416
    type
    RESULT
  3. 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 Surgeons Oncology Group Z0030 trial. Chest. 2011 May;139(5):1124-1129. doi: 10.1378/chest.10-0859. Epub 2010 Sep 9.
    pmid
    20829340
    type
    RESULT
  4. 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 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
    type
    RESULT
  5. citation
    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
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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        .54; <em>P</em> = .05).</li></ul></div></li><li>CMLND versus lymph node sampling was evaluated in a large randomized phase III trial (<a href="/clinicaltrials/NCT00003831">ACOSOG-Z0030</a> [NCT00003831]).[<a href="#cit/section_8.2">2</a>]<div class="pdq-content-list"><ul id="_485758"><li>Preliminary analyses of operative morbidi
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        l></div></li><li>CMLND versus lymph node sampling was evaluated in a large randomized phase III trial (<a href="/clinicaltrials/NCT00003831">ACOSOG-Z0030</a> [NCT00003831]).[<a href="#cit/section_8.2">2</a>]<div class="pdq-content-list"><ul id="_485758"><li>Preliminary analyses of operative morbidity and mortality showed compara
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        vel of evidence A1</a>]</li></ul></div></li><li>CMLND versus lymph node sampling was evaluated in a large randomized phase III trial (<a href="/clinicaltrials/NCT00003831">ACOSOG-Z0030</a>). Preliminary analyses of operative morbidity and mortality showed comparable rates from the procedures.[<a href="#cit/section_9.4">4</a>]<di
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      Non-Small Cell Lung Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 15, 2025
        datetime
        2025-05-15T12:00:00Z
        display
        May 15, 2025

    Preserved source evidence · Not medical advice