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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) Radiation Therapy Oncology Group American College of Surgeons Southwest Oncology Group |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00499330 |
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 | Intervention | Phase |
Lung Cancer |
Procedure: thoracoscopic surgery Procedure: videothoracoscopy |
Phase III |
MedlinePlus related topics: | Cancer Lung Cancer |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (≤ 2 CM) Peripheral Non-Small Cell Lung Cancer |
Estimated Enrollment: | 1297 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Arm I: Active Comparator
Patients undergo lobectomy by open thoracotomy or video-assisted thoracoscopic surgery (VATS).
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Procedure: thoracoscopic surgery
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
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Arm II: Experimental
Patients undergo a wedge resection or anatomical segmentectomy by open thoracotomy or VATS.
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Procedure: thoracoscopic surgery
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
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OBJECTIVES:
Primary
Secondary
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.
After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for up to 5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Intraoperative criteria
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*
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Show 108 Study Locations |
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 |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000555324, CALGB-140503, ECOG-40503 |
First Received: | July 10, 2007 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00499330 |
Health Authority: | Unspecified |
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