Japanese journal of clinical oncology
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Jpn. J. Clin. Oncol. · Feb 2015
Randomized Controlled Trial Multicenter Study Comparative StudyA double-blind randomized Phase II study of olanzapine 10 mg versus 5 mg for emesis induced by highly emetogenic chemotherapy.
A randomized Phase II dose-finding trial comparing olanzapine 10 mg with olanzapine 5 mg for patients receiving highly emetogenic chemotherapy with cisplatin was started in June 2014. The purpose of the trial is to evaluate the efficacy and safety of the two olanzapine doses and to determine which is more promising as a test arm for comparison with the current standard antiemetic care (a combination of aprepitant, a 5-HT3 receptor antagonist and dexamethasone) in a subsequent Phase III trial. ⋯ The primary endpoint is complete response defined as no emetic episodes and no use of rescue medications in the delayed (24-120 h) phase. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000014214.
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Jpn. J. Clin. Oncol. · Jan 2015
Randomized Controlled Trial Comparative StudyRandomized controlled trial comparing docetaxel-cisplatin combination with weekly docetaxel alone in elderly patients with advanced non-small-cell lung cancer: Japan Clinical Oncology Group (JCOG) 0207†.
Prospective trials specifically designed for elderly patients with advanced non-small-cell lung cancer demonstrating the benefit of platinum-based therapies are still lacking. This trial was designed to clarify whether the addition of cisplatin to monotherapy could improve survival for elderly patients. ⋯ The interpretation of study results is limited due to early stopping. Further study is needed to confirm survival benefit of platinum-based chemotherapy for elderly non-small-cell lung cancer [UMIN-CTR (www.umin.ac.jp/ctr/) ID: C000000146].
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Jpn. J. Clin. Oncol. · Feb 2014
Randomized Controlled Trial Comparative StudyA randomized controlled trial to verify the efficacy of the use of ultrasonography in breast cancer screening aged 40-49 (J-START): 76 196 women registered.
The objective of the Japan Strategic Anti-cancer Randomized Trial was to verify the efficacy of the use of ultrasonography in breast cancer screening among women aged 40-49 years. The purpose of this paper was to report the design and recruitment result of this study. ⋯ It was the first large-scale randomized controlled trial carried out in Japan. The scheduled second examinations were completed at the end of fiscal 2012. Once the proportion of participants whose status is unclear has fallen to ≤5%, the authors plan to collate the data relating to the primary end points, and publish the results.
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Jpn. J. Clin. Oncol. · Jun 2013
Randomized Controlled Trial Multicenter StudyEfficacy and safety of axitinib versus sorafenib in metastatic renal cell carcinoma: subgroup analysis of Japanese patients from the global randomized Phase 3 AXIS trial.
Axitinib is a potent and selective second-generation inhibitor of vascular endothelial growth factor receptors 1, 2 and 3. The efficacy and safety of axitinib in Japanese patients with metastatic renal cell carcinoma were evaluated. ⋯ Axitinib is efficacious and well tolerated in Japanese patients with previously treated metastatic renal cell carcinoma, consistent with the results in the overall population, providing a new targeted therapy for these Japanese patients.
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Jpn. J. Clin. Oncol. · Apr 2013
Randomized Controlled Trial Multicenter StudyEffect of Daikenchuto (TJ-100) on postoperative bowel motility and on prevention of paralytic ileus after pancreaticoduodenectomy: a multicenter, randomized, placebo-controlled phase II trial (the JAPAN-PD study).
We conducted a multicenter, randomized, controlled trial in patients with pancreaticoduodenectomy to investigate the efficacy of Daikenchuto (TJ-100), which is a Kampo medicine (traditional Japanese herbal medicine), for its effect on postoperative bowel motility and for prevention of postoperative paralytic ileus. This clinical trial primarily evaluates the co-primary endpoints: (i) the incidence rate of postoperative paralytic ileus lasting over 72 h after surgery and (ii) time to having the first postoperative passage of flatus. The secondary endpoints are the incidence of postoperative paralytic ileus in cases that combined with/without enteral alimentation, QOL assessment by the Gastrointestinal Symptom Rating Scale (GSRS) Score (Japanese Version) and visual analogue scale, the change ratio of abdominal circumference, the incidence of postoperative complication, the number of postoperative hospital days, the incidence of surgical site infection and the incidence of postoperative small bowel obstruction within 2 years after surgery. Two hundred and twenty patients are required in the study (110 patients per group).