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

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ClinicalTrials.gov Identifier: NCT00499330
Recruitment Status : Active, not recruiting
First Posted : July 11, 2007
Last Update Posted : March 25, 2024
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Description
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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.


Condition or disease Intervention/treatment Phase
Lung Cancer Procedure: lobectomy Procedure: segmentectomy or wedge resection Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 701 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (≤ 2 cm) Peripheral Non-Small Cell Lung Cancer
Actual Study Start Date : October 12, 2007
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Arm A
Patients undergo a standard operation for lung cancer called a lobectomy.
 Procedure: lobectomy
Experimental: Arm B
Patents undergo a limited resection (segentectomy or wedge resection), which a smaller portion of the lung is removed.
 Procedure: segmentectomy or wedge resection


Outcome Measures
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Primary Outcome Measures :
  1. disease-free survival [ Time Frame: Up to 7 years ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: Up to 7 years ]
  2. rate of loco-regional and systemic recurrence [ Time Frame: Up to 7 years ]
  3. pulmonary function as measured by expiratory flow rate 6 months postoperatively [ Time Frame: at 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499330


Locations
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Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: Nasser Altorki, MD Weill Medical College of Cornell University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00499330    
Other Study ID Numbers: CALGB 140503
CALGB-140503
CDR0000555324 ( Registry Identifier: NCI Physician Data Query )
NCI-2009-00447 ( Registry Identifier: NCI Clinical Trial Reporting Program )
First Posted: July 11, 2007    Key Record Dates
Last Update Posted: March 25, 2024
Last Verified: March 2024
Keywords provided by Alliance for Clinical Trials in Oncology:
stage IA non-small cell lung cancer
adenocarcinoma of the lung
squamous cell lung cancer
 large cell lung cancer
adenosquamous cell lung cancer
bronchoalveolar cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms