Gan to kagaku ryoho. Cancer & chemotherapy
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The new Japanese GCP enacted on the basis of ICH-GCP adopts more clear concepts of quality assurance for a clinical trial. This article briefly describes its principles. ⋯ Further, this addresses the required reorganization which the sponsor should strive for as well as the sponsor's requests to participating medical institutions such as adoption of a "study coordinator". To improve the quality of a clinical trial, it would be necessary to refer not only to GCP but also to other current guidelines such as those harmonized at the ICH.
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In 1997, a new GCP has taken effect by the Ministry of Health and Welfare, Japan, and will be enforced as of April, 1998. The GCP regulates the method of clinical trials in the light of ethics and science. The New GCP requires written informed consent, enforcement of the responsibility of the client and so on.
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Gan To Kagaku Ryoho · Mar 1998
Randomized Controlled Trial Comparative Study Clinical Trial[Effect of granisetron in preventing emesis due to anti-cancer drug (CDDP) administration pulmo-mediastinal malignancies--comparison of simultaneous infusion with the conventional method of administration].
For patients with pulmo-mediastinal malignancies, the antimetic effect of granisetron was studied in the following two ways. Firstly in the standard method, 40 micrograms/kg of granisetron was infused for 30 minutes, 30 minutes before CDDP infusion. ⋯ The non-effective rates were 18.2% and 15.8%, respectively. Although the results were not statistically significant, the simultaneous method is easier to perform and it seems to confer a slightly better clinical outcome than the conventional method.
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Gan To Kagaku Ryoho · Mar 1998
Case Reports[A case of multiple liver metastasis of gastric cancer responding to hepatic arterial infusion chronotherapy].
A 64-year-old man underwent total gastrectomy and placement of the hepatic arterial catheter for advanced gastric cancer with multiple liver metastasis. After the operation, repeated hepatic arterial infusion chemotherapy was performed. ⋯ A total of 13 courses of this chemotherapy diminished liver metastasis. During this therapy, the patient's condition was good, with no experience of nausea or leukopenia.
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Gan To Kagaku Ryoho · Feb 1998
Clinical Trial[Efficacy of combination of ondansetron injection and tablet in CAF-induced emesis in breast cancer patients].
Efficacy of combination of ondansetron injection and tablet on CAF (cyclophosphamide, adriamycin, 5-fluorouracil) induced emesis were investigated in 10 breast cancer patients (33 courses). Complete suppression rate of nausea or vomiting were approximately 75%, approximately 90% respectively for every treatment day. According to judgement criteria, antiemetic rate of approximately 100% was achieved during the study period. ⋯ In this investigation, combination of ondansetron injection and tablet was shown to sufficiently suppress CAF-induced nausea and vomiting, and their efficacy was confirmed. Still, the study suggested that number of emetic episodes or degree of anorexia differs according to each individual. Therefore we regard additional administration of ondansetron or concomitant use of steroids should be considered when necessary.