Gan to kagaku ryoho. Cancer & chemotherapy
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There are many things that we can learn from the clinical trials conducted in the U. S. They move ahead based on explicit basic principles regarding various matters such as the method for setting up the clinical trial system, selection of CRO, selection of investigators, monitoring activities that are mainly based on their direct access to source documents and sponsor's action when a lack of compliance with GCP occurs. ⋯ It is evident that compliance with these standards is ensured in the U. S. by the activities of study coordinators who take greater part in the clinical studies themselves. In order to expedite introduction of the study coordinator system in Japan even just a little, sponsors should consider providing medical institutions with relevant information as well as a chance to educate and train their study coordinators to optimize the function.
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Gan To Kagaku Ryoho · Jan 1999
Multicenter Study Clinical Trial[Late phase II clinical study of RP56976 (docetaxel) in patients with advanced/recurrent head and neck cancer].
A late phase II clinical study of RP56976 (docetaxel), a new anticancer agent for advanced/recurrent head and neck cancer, was conducted in 29 institutions all over Japan as a multi-institutional cooperative study. Docetaxel was administered by 1 to 2-hour intravenous infusion at a dose of 60 mg/m2 every 3 to 4 weeks. Of 63 patients eligible in this study, 59 were judged as complete cases. ⋯ One patient had a grade 3 interstitial pneumonia; however, symptoms were resolved by the administration of corticosteroids. During this study, one patient died due to multiple organ failure (MOF) caused by disseminated intravascular coagulation (DIC), and this case was reported as a therapy-related death. Based on these results, docetaxel is an active agent for treatment of head and neck cancer.
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Gan To Kagaku Ryoho · Jan 1999
ReviewSurgery and multimodal treatments in pancreatic cancer--a review on the basis of future multimodal treatment concepts.
To improve the surgical outcome after resection of pancreatic adenocarcinomas, multimodal treatment concepts need to be applied and improved. In spite of several positive studies, and the fact that multimodality treatment is the standard concept in major centers for pancreatic cancer surgery, a recent trial shed some doubt on the positive effect of adjuvant radiochemotherapy, so that the majority with reservations about multimodal treatment feel confirmed in their opinion that surgical treatment alone is sufficient therapy for resectable pancreatic cancer. The controversy among those for and against adjuvant treatment need an up-to-date review of the indications and results achievable with various treatment modalities. ⋯ Postoperative adjuvant radiochemotherapy with up-to-date protocols can be recommended for routine treatment, if the surgeon or the patient desires to improve the usually remote prognosis after surgery alone. For those being undecisive or against adjuvant therapy, the participation in trials, e.g., ESPAC 1 and 2 studies, is strongly recommended. Regarding our own positive experience with adjuvant regional chemotherapy and in view of the postresectional progression pattern, we currently favour adjuvant radiochemotherapy, with the chemotherapy delivered regionally via the celiac axis. This concept will be tested vs. surgery alone in the ESPAC 2 trial. Neoadjuvant therapies have a great potential, but should be conducted within studies, such as pre-, intra-, or postoperative radiotherapy.
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Gan To Kagaku Ryoho · Jan 1999
Review[Roles of nurses in clinical trials of anticancer drug development].
In Japan nurses were not much involved in clinical trials in connection with new drug development in the field of cancer nursing in the past for the following reasons: 1) systems for cooperations among different services in hospital were not well established. 2) There was a lack of information about the drugs from physicians, 3) It was difficult to obtain informed consent from patients. In the new GCP system of Japan started last April in accordance with ICH-GCP, persons who support patients and assist physician investigators are desperately needed to maintain QA and QC of the clinical trials. Research nurses are the most suitable persons to fulfill such positions. The roles of research nurses in these settings are patient care, coordinator, data collecting and educator in the new system.
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It is necessary for us to reform the infrastructure for clinical trials in Japan in this new GCP era. Medical institutions for clinical trials should prepare to implement monitoring and auditing procedures for quality control and quality assurance of clinical trials. It is also necessary to ease the burden and improve the benefits of participating in clinical trials by subjects. Although there has been no effort to educate and train CRC/SC staff at all in Japan, future improvement in this area is needed to bring the quality of Japan's clinical trials up to international standards.