Lung cancer : journal of the International Association for the Study of Lung Cancer
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Randomized Controlled Trial Multicenter Study
Nodule management protocol of the NELSON randomised lung cancer screening trial.
In December 2003, the Dutch-Belgian NELSON trial, a Dutch acronym for "Nederlands-Leuvens Longkanker Screenings ONderzoek", has been launched. Primary objective of the NELSON trial is to investigate whether screening for lung cancer by 16-detector multi-slice CT with 16 mm x 0.75 mm collimation and 15 mm table feed per rotation (pitch=1.5) in year 1, 2 and 4 will lead to a decrease in lung cancer mortality in high risk subjects of at least 25% compared to a control group which receives no screening. ⋯ This is the first large lung cancer screening trial in which the nodule management protocol is based on volumetric nodule assessment and the presence or absence of growth. Furthermore, the quality assurance measures and the NELSON management system (NMS) are presented.
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Randomized Controlled Trial
Efficacy of short-term versus long-term chest tube drainage following talc slurry pleurodesis in patients with malignant pleural effusions: a randomised trial.
Talc pleurodesis is commonly used in the palliative treatment of malignant pleural effusions but the shortest and most effective regime has not been determined. In particular, it is not clear when the intercostal drain should be removed following the insertion of sclerosant. We conducted a single-centre, randomised, open trial of drain removal at 24 h versus 72 h following talc slurry pleurodesis. ⋯ However, length of stay was significantly reduced when the chest drain was removed at 24 h (4 days versus 8 days; p<0.01). Mortality did not differ between the two groups. We conclude that this shorter pleurodesis regime is safe and effective.
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Randomized Controlled Trial
Phase II study of the combination of gemcitabine and nedaplatin for advanced non-small-cell lung cancer.
We examined the efficacy and safety of the combination of gemcitabine and nedaplatin in patients with untreated advanced non-small-cell lung cancer. Thirty-four patients (24 men and 10 women) with a mean age of 69 years (range, 39-75 years) were treated every 3 weeks with gemcitabine (1,000 mg/m(2) on days 1 and 8) and nedaplatin (100 mg/m(2) on day 1). Four patients had stage IIIB disease and 30 patients had stage IV disease. ⋯ There were no treatment-related deaths. The dose intensities were 89.6% and 86.7%, respectively, of the planned doses of gemcitabine and nedaplatin. Our results suggest that the combination of gemcitabine and nedaplatin is an acceptable treatment for patients with previously untreated advanced non-small-cell lung cancer.
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Randomized Controlled Trial Multicenter Study
Phase II study of PKC-alpha antisense oligonucleotide aprinocarsen in combination with gemcitabine and carboplatin in patients with advanced non-small cell lung cancer.
The antisense oligonucleotide aprinocarsen specifically inhibits the transcription of protein kinase C-alpha. This study evaluated the response rate of the combination therapy of aprinocarsen, gemcitabine, and carboplatin in previously untreated patients with advanced non-small cell lung cancer (NSCLC). Secondary objectives included the measurement of time-to-event efficacy parameters and toxicity. ⋯ Enrollment for this study was stopped and the study was terminated in March 2003 due to the results of a large phase III study, which suggested that aprinocarsen did not improve response or add survival benefit to chemotherapy in advanced NSCLC. The addition of aprinocarsen to gemcitabine+carboplatin therapy in patients with NSCLC showed moderate activity. However, this combination resulted in severe thrombocytopenia in the majority of patients.
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Randomized Controlled Trial
Cisplatin and gemcitabine first-line chemotherapy followed by maintenance gemcitabine or best supportive care in advanced non-small cell lung cancer: a phase III trial.
The primary objective of this randomized phase III study was to show significant difference in median time to progression (TTP) in patients with advanced NSCLC treated with single-agent gemcitabine maintenance therapy versus best supportive care following gemcitabine plus cisplatin initial first-line therapy. ⋯ Maintenance therapy with gemcitabine, following initial therapy with gemcitabine plus cisplatin, was feasible, and produced significantly longer TTP compared to best supportive care alone. Further studies are warranted to establish the place of maintenance chemotherapy in patients with advanced NSCLC.