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Title:
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Phase II ERCC 1and RRM1-Based Adjuvant Therapy Trial in Patients with Stage I Non-Small Cell Lung Cancer (NSCLC) - IRB# 09-002A
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Treatments:
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Cisplatin, Gemcitabine
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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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Eligibility:
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Histologically confirmed non-small cell lung cancer. Stage IA (longest tumor diameter 2-3 cm) or stage IB disease. Must have undergone preoperative CT scan of the chest (including the entire liver and adrenals) with IV contrast AND a whole body PET scan or a combined PET/CT scan with no evidence of N1, N2, N3, or M1 disease within 42 days prior to surgery. Completely resected (R0) disease by lobectomy, bilobectomy, or pneumonectomy performed by open thoracotomy or video-assisted thoracoscopic surgery within the past 35 days. Completely excised primary lesion with negative gross and microscopic margins. At least two mediastinal lymph node stations sampled. Must have tumor tissue available from the surgical resection specimen AND agree to have treatment assignment determined by a gene expression analysis performed on that tissue. Prior/Concurrent Therapy: See Disease Characteristics. No prior systemic chemotherapy or biologic therapy for lung cancer. No prior thoracic radiation therapy (RT) (including RT to the chest wall). No other concurrent investigational agents, chemotherapeutic agents, RT, or hormonal therapy. Steroids administered for antiemesis, adrenal failure, or septic shock OR hormones administered for non-disease-related conditions (e.g., insulin for diabetes) allowed.
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Participating Sites:
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Adventist Medical Center, Northwest Cancer Specialists, Providence Milwaukie Hospital, Providence Portland Medical Center, Providence St. Vincent Medical Center, Southwest Washington Medical Center
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