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Title:
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A Phase III Randomized Trial of Lobectomy versus Sublobar Resection for Small (<=2 cm) Peripheral Non-Small Cell Lung Cancer - IRB# 08-125B
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Treatments:
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Lobectomy, Sublobar Resection
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Disease Site:
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Lung
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Disease SubSite:
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Non Small Cell Lung
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Drug Provided:
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-- none --
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Comments:
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INVESTIGATORS MUST CREDENTIALED TO ENROLL ON THIS STUDY.
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Eligibility:
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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 or at the time of thoracotomy or video-assisted thoracoscopic surgery (VATS) exploration* [Note: *Nodes previously sampled by mediastinoscopy either immediately prior to 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. Prior/Concurrent Therapy: No prior chemotherapy or radiotherapy for this malignancy. Patient Characteristics: ECOG performance status 0-2. No other malignancy within the past 5 years except for nonmelanoma skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix.
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Participating Sites:
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Providence Portland Medical Center
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