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Uracil-Tegafur (UFT), an oral fluorinated pyrimidine chemotherapeutic agent, has been used for adjuvant chemotherapy in curatively resected colorectal cancer patients. Past trials and meta-analyses indicate that it is somewhat effective in extending survival of patients with rectal cancer. The objective of this study was to perform a reappraisal of(More)
BACKGROUND The antiplatelet drug cilostazol is efficacious for prevention of stroke recurrence compared with placebo. We designed the second Cilostazol Stroke Prevention Study (CSPS 2) to establish non-inferiority of cilostazol versus aspirin for prevention of stroke, and to compare the efficacy and safety of cilostazol and aspirin in patients with(More)
BACKGROUND We evaluated the efficacy and safety of S-1 plus oxaliplatin (SOX) as an alternative to cisplatin plus S-1 (CS) in first-line chemotherapy for advanced gastric cancer (AGC). PATIENTS AND METHODS In this randomized, open-label, multicenter phase III study, patients were randomly assigned to receive SOX (80-120 mg/day S-1 for 2 weeks with 100(More)
We conducted clinical trials in patients with acute lung injury (ALI) associated with systemic inflammatory response syndrome using a selective neutrophil elastase inhibitor, sivelestat sodium hydrate (Sivelestat), to investigate the involvement of neutrophil elastase in ALI. In the phase III double-blind study (Study 1) in 230 patients, the efficacy of(More)
OBJECTIVE Although sleeve lobectomy for lung cancer is widely accepted as an alternative to pneumonectomy, its use remains controversial. This study aimed to evaluate the surgical results after sleeve lung resection and to compare the outcomes of different procedural approaches. METHODS The medical records of 201 patients who underwent sleeve lung(More)
BACKGROUND This randomised, open-label, multicenter phase II study compared progression-free survival (PFS) of S-1 plus oxaliplatin (SOX) with that of S-1 alone in patients with gemcitabine-refractory pancreatic cancer. METHODS Patients with confirmed progressive disease following the first-line treatment with a gemcitabine-based regimen were randomised(More)
In this paper, we propose a partition testing for adaptive clinical trials with structured study objectives. The proposed approach is a combination of the graphical approach with partition testing. The proposed approach enables one to handle many types of structured objectives, to tailor a multiple test procedure to given structured objectives, and to draw(More)
BACKGROUND Treatments that confer survival benefit are needed in patients with heavily pretreated metastatic colorectal cancer. The aim of this trial was to investigate the efficacy and safety of TAS-102-a novel oral nucleoside antitumour agent. METHODS Between August 25, 2009, and April 12, 2010, we undertook a multicentre, double-blind, randomised,(More)
OBJECTIVE We aimed to identify prognostic factors after pulmonary metastasectomy for colorectal cancer and propose the clinical application of them. Furthermore, we endeavored to provide a rationale for pulmonary metastasesectomy. BACKGROUND Several prognostic factors have been proposed, but clinical application of them remains unclear. Moreover, there is(More)
BACKGROUND Irinotecan hydrochloride and S-1, an oral fluoropyrimidine, have shown antitumor activity against advanced gastric cancer as single agents in phase I/II studies. The combination of irinotecan and S-1 (IRI-S) is also active against advanced gastric cancer. This study was conducted to compare the efficacy and safety of IRI-S versus S-1 monotherapy(More)