Gan to kagaku ryoho. Cancer & chemotherapy
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The Brain is one of the common relapse sites in small cell lung cancer because of isolation from chemotherapeutic agents by the blood-brain barrier. Prophylactic cranial irradiation (PCI) is expected to reduce brain relapse and increase the survival rate. PCI prolonged the survival in only 10-20% of patients with small cell lung cancer after complete response. ⋯ No standard PCI dose and schedule are established, however, over 30Gy for total dose, over 3Gy per fraction. Concurrent use with chemotherapy is considered to induce central nerve toxicity. PCI should be proposed for patients with complete response as an optional treatment.
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Gan To Kagaku Ryoho · Oct 1997
[Implementation of new Japanese GCP and the quality of clinical trials--from the standpoint of the pharmaceutical industry].
As a part of the amendment of the pharmaceutical law and regulations in Japan, the GCP has been revised and enacted into the law and regulations. The new GCP is based on ICH-GCP and aims at upholding the quality of the Japanese clinical trials to an internationally acceptable level. The roles of the people involved in clinical trials have been renewed. ⋯ In this article are described major responsibilities newly assigned to the sponsor, medical institutions and investigators as well as the matters to be tackled. Discussion was also made extending the theme to matters other than GCP for upholding the quality of clinical trials in Japan to the internationally acceptable level. It is evident that we will confront many difficulties to solve these matters, but the implementation of the new GCP should give us a good chance to improve the quality of clinical studies performed in Japan.