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Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer

This study is currently recruiting participants.
Verified February 2013 by National Cancer Institute (NCI)
Sponsor:
Collaborators:
Radiation Therapy Oncology Group
American College of Surgeons
Southwest Oncology Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00499330
First received: July 10, 2007
Last updated: February 15, 2013
Last verified: February 2013

July 10, 2007
February 15, 2013
June 2007
March 2021   (final data collection date for primary outcome measure)
Disease-free survival [ Designated as safety issue: No ]
Disease-free survival
Complete list of historical versions of study NCT00499330 on ClinicalTrials.gov Archive Site
  • Overall survival [ Designated as safety issue: No ]
  • Rate of loco-regional and systemic recurrence [ Designated as safety issue: No ]
  • Pulmonary function as measured by expiratory flow rate 6 months postoperatively [ Designated as safety issue: No ]
  • Overall survival
  • Rate of loco-regional and systemic recurrence
  • Pulmonary function as measured by expiratory flow rate 6 months postoperatively
Not Provided
Not Provided
 
Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer
A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (≤ 2 CM) Peripheral Non-Small Cell Lung Cancer

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.

OBJECTIVES:

Primary

  • Compare the disease-free survival of patients with small (≤ 2 cm) peripheral stage IA non-small cell lung cancer undergoing lobectomy vs sublobar resection (wedge resection or segmentectomy).

Secondary

  • Compare the overall survival of patients undergoing lobectomy vs sublobar resection.
  • Compare the rates of loco-regional and systemic recurrence in patients undergoing lobectomy vs sublobar resection.
  • Compare the pulmonary function of these patients, as measured by expiratory flow rates at 6 months postoperatively.
  • Explore the relationship between characteristics of the primary lung cancer, as revealed by pre-operative CT scan and positron emission tomography (PET) imaging, and outcomes.
  • Determine the false-negative rate of preoperative PET scan for identification of involved hilar and mediastinal lymph nodes.
  • Assess the utility of annual follow-up CT scan after surgical resection in these patients.

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 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.

  • Arm I: Patients undergo lobectomy by open thoracotomy or video-assisted thoracoscopic surgery (VATS).
  • Arm II: Patients undergo a wedge resection or anatomical segmentectomy by open thoracotomy or VATS.

After completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 5 years.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Lung Cancer
  • Procedure: therapeutic thoracoscopy
    Patients undergo lobectomy, wedge resection, or anatomical segmentectomy by thoracoscopic surgery
  • Procedure: videothoracoscopy
    Patients undergo lobectomy, wedge resection, or anatomical segmentectomy by video-assisted thoracoscopic surgery
  • Active Comparator: Arm I
    Patients undergo lobectomy by open thoracotomy or video-assisted thoracoscopic surgery (VATS).
    Interventions:
    • Procedure: therapeutic thoracoscopy
    • Procedure: videothoracoscopy
  • Experimental: Arm II
    Patients undergo a wedge resection or anatomical segmentectomy by open thoracotomy or VATS.
    Interventions:
    • Procedure: therapeutic thoracoscopy
    • Procedure: videothoracoscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1258
Not Provided
March 2021   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Suspected or proven non-small cell lung cancer (NSCLC), meeting both preoperative and intraoperative criteria:

    • Preoperative criteria

      • Peripheral lung nodule ≤ 2 cm by CT scan

        • Center of the tumor must be located in the outer third of the lung in either the transverse, coronal, or sagittal plan
        • Tumor location must be suitable for either lobar or sublobar resection (wedge resection or segmentectomy)
      • No pure ground opacities or pathologically confirmed N1 or N2 disease
    • Intraoperative criteria

      • Histologically confirmed NSCLC
      • Confirmation of N0 status by frozen section examination of nodal levels 4, 7, and 10 on the right side and 5, 6, 7, and 10 on the left side*

        • 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 video-assisted thoracoscopic surgery (VATS) exploration* NOTE: *Nodes previously sampled by mediastinoscopy (or EBUS and/or EUS) either immediately before or within 6 weeks of the definitive surgical procedure (thoracotomy or VATS) do not need to be resampled
  • No evidence of locally advanced or metastatic disease

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • No other malignancy within the past 3 years except for nonmelanoma skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy for this malignancy
Both
18 Years and older
No
Not Provided
United States,   Canada
 
NCT00499330
CDR0000555324, CALGB-140503, ECOG-40503
Not Provided
Monica M. Bertagnolli, Cancer and Leukemia Group B
Cancer and Leukemia Group B
  • National Cancer Institute (NCI)
  • Radiation Therapy Oncology Group
  • American College of Surgeons
  • Southwest Oncology Group
Study Chair: Nasser K. Altorki, MD Weill Medical College of Cornell University
Study Chair: Harvey I. Pass, MD New York University School of Medicine
Study Chair: Daniel L. Miller, MD Emory University
Study Chair: Kemp H. Kernstine, MD, PhD Holden Comprehensive Cancer Center
National Cancer Institute (NCI)
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP