Finding studies
Finding studies
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Lead
National Cancer Institute (NCI)
Background: * Stage IIIA-N2 is considered one of the most therapeutically challenging and controversial subsets of lung cancer. This heterogenous group of patients have tumors which range from minimal N2 (found incidentally during or after surgery) to multi-station bulky N2 disease. The extent of mediastinal involvement has an inverse correlation with survival. * The 5-year survival ranges from 5-8% in patients with bulky N2 disease, to nearly 35% in patients with single station, microscopic N2 involvement. * Neo-adjuvant chemotherapy and chemo-radiotherapy have been shown to be superior to surgery alone. * Platinum-based induction chemotherapy in early and locally advanced non small cell lung cancer (NSCLC) results in a radiological down-staging in at least 50% of patients, and a pathological complete response rate of approximately 5%. * Concurrent chemo-radiotherapy as an induction regimen increases the radiological and pathological down-staging rate, but at the cost of increasing the morbidity and mortality of a surgical intervention. * Expectations have now turned towards a possible incremental effect of adding a targeted biological agent to a standard induction treatment. Primary Objectives: * To determine the safety of neo-adjuvant Gemcitabine/Cisplatin and Bevacizumab in stage IIIA-N2 non small cell lung cancer (NSCLC) * To determine the pathological complete response rate * To determine the resectability rate * To determine the extent of surgery Eligibility: * Histologically confirmed stage IIIA-N2 NSCLC (non-squamous) * No previous chemotherapy, radiotherapy, surgery or biological therapy for lung cancer * Adequate organ and bone marrow function Design: * Multi-center, international (United States Of America (USA)/Croatia), open labeled phase II trial * Following a Simon two-stage optimal design
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
