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NCT00499330 · CITED IN SOURCE DOCUMENTS

Comparison of Different Types of Surgery in Treating Patients With Stage IA 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
Not reported
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2026-07-16

RATIONALE: Wedge resection or segmentectomy may be less invasive types of surgery than lobectomy for non-small cell lung cancer and may have fewer side effects and improve recovery. It is not yet known whether wedge resection or segmentectomy are more effective than lobectomy in treating stage IA non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying different types of surgery to compare how well they work in treating patients with stage IA 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
Pre-registration Eligibility Criteria: 1. Peripheral lung nodule ≤ 2 cm on preoperative CT scan and presumed to be lung cancer. The center of the tumor, as seen on CT, must be located in the outer third of the lung in either the transverse, coronal or sagittal plane. Patients with pure ground glass opacities or pathologically confirmed N1 or N2 disease are not eligible. 2. The tumor location must be suitable for either lobar or sublobar resection (wedge or segment). 3. ECOG performance status of 0-2. 4. No prior malignancy within 3 years other than non-melanoma skin cancer, superficial bladder cancer, or CIS of the cervix. 5. No prior chemotherapy or radiation therapy for this malignancy. 6. No evidence of locally advanced or metastatic disease. 7. Age ≥ 18 years Intra-operative Randomization Eligibility Criteria: 1. Histologic confirmation of NSCLC (if not already obtained) 2. Confirmation of N0 status by frozen section examination. Right sided tumors require that node levels 4, 7, and 10 be sampled and diagnosed as negative on frozen section. Left sided tumors require that node levels 5 or 6, 7 and 10 be sampled and diagnosed as negative on frozen section. Levels 4 and 7 nodes may be sampled by mediastinoscopy, endobronchial ultrasound (EBUS) and/or endoscopic ultrasound (EUS), or at the time of thoracotomy or VATS exploration. Nodes previously sampled by mediastinoscopy (or EBUS and/or EUS) either immediately prior to or within 6 weeks of the definitive surgical procedure (thoracotomy or VATS) do not need to be resampled.
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 a standard operation for lung cancer called a lobectomy.
    intervention Names
    1. Procedure: lobectomy
    label
    Arm A
    type
    OTHER
  2. description
    Patents undergo a limited resection (segentectomy or wedge resection), which a smaller portion of the lung is removed.
    intervention Names
    1. Procedure: segmentectomy or wedge resection
    label
    Arm B
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm A
    name
    lobectomy
    type
    PROCEDURE
  2. arm Group Labels
    1. Arm B
    name
    segmentectomy or wedge resection
    type
    PROCEDURE
Study designSource null
EnrollmentSource null
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    disease-free survival
    time Frame
    Up to 7 years
secondary Outcomes
  1. measure
    overall survival
    time Frame
    Up to 7 years
  2. measure
    rate of loco-regional and systemic recurrence
    time Frame
    Up to 7 years
  3. measure
    pulmonary function as measured by expiratory flow rate 6 months postoperatively
    time Frame
    at 6 months
Full study description
brief Summary
RATIONALE: Wedge resection or segmentectomy may be less invasive types of surgery than lobectomy for non-small cell lung cancer and may have fewer side effects and improve recovery. It is not yet known whether wedge resection or segmentectomy are more effective than lobectomy in treating stage IA non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying different types of surgery to compare how well they work in treating patients with stage IA non-small cell lung cancer.
detailed Description
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to tumor size (\< 1 cm vs 1-1.5 cm vs \> 1.5-2.0 cm) (based on the maximum dimension determined from the preoperative CT scan), histology (squamous cell carcinoma vs adenocarcinoma vs other), and smoking status (never smoked \[smoked \< 100 cigarettes over lifetime\] vs former smoker \[smoked \> 100 cigarettes AND quit ≥ 1 year ago\] vs current smoker \[quit \< 1 year ago or currently smokes\]). Patients are randomized to 1 of 2 treatment arms. For more information, please see the Arms section. Primary Objective: To determine whether DFS after sublobar resection (segmentectomy or wedge) is non-inferior to that after lobectomy in patients with small peripheral (≤ 2 cm) NSCLC. Secondary Objectives: 1. To determine whether overall survival (OS) (after sublobar resection) is non-inferior to that after lobectomy. 2. To determine the rates of loco-regional and systemic recurrence (exclusive of second primaries) after lobar and sublobar resection. 3. To determine the difference between the two arms of the study in pulmonary function as determined by expiratory flow rates measured at 6 months post-operatively. 4. Imaging Substudy: To explore the relationship between characteristics of the primary lung cancer, as revealed by pre-operative CT and PET imaging, and outcomes; a determination of the false-negative rate of the pre-operative PET scan for identification of involved hilarand mediastinal lymph nodes; and an assessment of the utility of annual follow-up CT imaging after surgical resection of small stage IA NSCLC. After completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 5 years.
Source references
references
  1. citation
    Ganti AK, Damman B, Wang X, Stinchcombe TE, Altorki N. Outcomes Based on Age in CALGB 140503 (Alliance): Lobar Versus Sublobar Resection for Peripheral Stage IA Non-small Cell Lung Cancer. Clin Lung Cancer. 2026 Jul 2;27(7):42-49. doi: 10.1016/j.cllc.2026.06.009. Online ahead of print.
    pmid
    42501610
    type
    DERIVED
  2. citation
    Altorki N, Damman B, Wang X, Liberman M, Wigle D, Ashrafi A, Conti M, Yasufuku K, Schuchert MJ, Stinchcombe TE. The extent of lymph node dissection is not associated with disease-free survival following lobar or sublobar resection: Results from Cancer and Leukemia Group B 140503 (Alliance). J Thorac Cardiovasc Surg. 2025 Oct;170(4):933-942.e2. doi: 10.1016/j.jtcvs.2025.06.007. Epub 2025 Jun 16.
    pmid
    40532782
    type
    DERIVED
  3. citation
    Stinchcombe TE, Wang X, Damman B, Mentlick J, Landreneau R, Wigle D, Jones DR, Conti M, Ashrafi AS, Liberman M, de Perrot M, Mitchell JD, Keenan R, Bauer T, Miller D, Altorki N. Secondary Analysis of the Rate of Second Primary Lung Cancer From Cancer and Leukemia Group B 140503 (Alliance) Trial of Lobar Versus Sublobar Resection for T1aN0 Non-Small-Cell Lung Cancer. J Clin Oncol. 2024 Apr 1;42(10):1110-1113. doi: 10.1200/JCO.23.01306. Epub 2024 Jan 12.
    pmid
    38215351
    type
    DERIVED
  4. citation
    Altorki N, Wang X, Kozono D, Watt C, Landrenau R, Wigle D, Port J, Jones DR, Conti M, Ashrafi AS, Liberman M, Yasufuku K, Yang S, Mitchell JD, Pass H, Keenan R, Bauer T, Miller D, Kohman LJ, Stinchcombe TE, Vokes E. Lobar or Sublobar Resection for Peripheral Stage IA Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Feb 9;388(6):489-498. doi: 10.1056/NEJMoa2212083.
    pmid
    36780674
    type
    DERIVED
  5. citation
    Altorki NK, Wang X, Wigle D, Gu L, Darling G, Ashrafi AS, Landrenau R, Miller D, Liberman M, Jones DR, Keenan R, Conti M, Wright G, Veit LJ, Ramalingam SS, Kamel M, Pass HI, Mitchell JD, Stinchcombe T, Vokes E, Kohman LJ. Perioperative mortality and morbidity after sublobar versus lobar resection for early-stage non-small-cell lung cancer: post-hoc analysis of an international, randomised, phase 3 trial (CALGB/Alliance 140503). Lancet Respir Med. 2018 Dec;6(12):915-924. doi: 10.1016/S2213-2600(18)30411-9. Epub 2018 Nov 12.
    pmid
    30442588
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        dergone complete resections.[<a href="#cit/section_7.4">4</a>]</li></ul></div></li><li>A multicenter, noninferiority, phase III trial (<a href="/clinicaltrials/NCT00499330">NCT00499330</a>) evaluated lobar or sublobar resection in patients with peripheral stage IA NSCLC. A total of 697 patients with clinical stage T1a, N0 tumors
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        ete resections.[<a href="#cit/section_7.4">4</a>]</li></ul></div></li><li>A multicenter, noninferiority, phase III trial (<a href="/clinicaltrials/NCT00499330">NCT00499330</a>) evaluated lobar or sublobar resection in patients with peripheral stage IA NSCLC. A total of 697 patients with clinical stage T1a, N0 tumors (tumor size &
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      Non-Small Cell Lung Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 15, 2025
        datetime
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        display
        May 15, 2025

    Preserved source evidence · Not medical advice