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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00499330
First received: July 10, 2007
Last updated: August 28, 2015
Last verified: August 2015

July 10, 2007
August 28, 2015
June 2007
March 2021   (final data collection date for primary outcome measure)
disease-free survival [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
Disease-free survival
Complete list of historical versions of study NCT00499330 on ClinicalTrials.gov Archive Site
  • overall survival [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • rate of loco-regional and systemic recurrence [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • pulmonary function as measured by expiratory flow rate 6 months postoperatively [ Time Frame: at 6 months ] [ 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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Procedure: lobectomy
  • Procedure: segmentectomy or wedge resection
  • Arm A
    Patients undergo a standard operation for lung cancer called a lobectomy.
    Intervention: Procedure: lobectomy
  • Experimental: Arm B
    Patents undergo a limited resection (segentectomy or wedge resection), which a smaller portion of the lung is removed.
    Intervention: Procedure: segmentectomy or wedge resection
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)

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.
Both
18 Years and older
No
Contact: Nasser Altorki, MD 212 746-5156
United States,   Canada
Australia
 
NCT00499330
CALGB-140503, CALGB-140503, CDR0000555324
No
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Nasser Altorki, MD Weill Medical College of Cornell University
Alliance for Clinical Trials in Oncology
August 2015

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