Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00499330
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 701
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method disease-free survival Up to 7 years
- Secondary Outcome Measures
Name Time Method rate of loco-regional and systemic recurrence Up to 7 years pulmonary function as measured by expiratory flow rate 6 months postoperatively at 6 months overall survival Up to 7 years
Trial Locations
- Locations (385)
University of Alabama at Birmingham Cancer Center
🇺🇸Birmingham, Alabama, United States
Anchorage Associates in Radiation Medicine
🇺🇸Anchorage, Alaska, United States
Anchorage Radiation Therapy Center
🇺🇸Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC
🇺🇸Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC
🇺🇸Anchorage, Alaska, United States
Alaska Regional Hospital
🇺🇸Anchorage, Alaska, United States
Alaska Women's Cancer Care
🇺🇸Anchorage, Alaska, United States
Anchorage Oncology Centre
🇺🇸Anchorage, Alaska, United States
Katmai Oncology Group
🇺🇸Anchorage, Alaska, United States
Providence Alaska Medical Center
🇺🇸Anchorage, Alaska, United States
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