Gan to kagaku ryoho. Cancer & chemotherapy
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Gan To Kagaku Ryoho · Aug 1995
Randomized Controlled Trial Multicenter Study Clinical TrialInduction chemotherapy and irradiation in advanced carcinoma of the cervix.
The survival rate of patients with locally advanced cervical cancer has not changed during the past several years. The purpose of the study is to evaluate the efficacy of concomitant Mitomycin and 5-FU with irradiation. Six hundred seventy-three patients were randomized into four arms. ⋯ The disease-free survival data from life table analysis suggested a better disease-free survival in arms 3 and 4 (concomitant arms) and arm 2 (maintenance oral 5-FU arm) than in control (RT alone arm). The pattern of failure showed a greater difference in loco-regional recurrence in stage IIB than IIIB patients. This interim analysis shows a trend favoring the arm with concomitant chemotherapy.
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Gan To Kagaku Ryoho · Aug 1995
Multicenter Study Comparative Study Clinical Trial Controlled Clinical Trial[Clinical phase III study of tropisetron capsule in the treatment of nausea and vomiting induced by anti-cancer drug; a placebo-controlled, multicenter, double-blind comparative study].
A placebo-controlled, double-blind comparative study of tropisetron capsule was conducted to assess its clinical usefulness for nausea and vomiting induced by the anticancer drug, cisplatin, at a single dose of 50 mg/m2 or higher. Either 5mg tropisetron capsule or its placebo was given orally to patients 2 hours prior to cisplatin administration; the clinical efficacy was determined the severity of nausea and the number of emesis that occurred during 24 hours after cisplatin. Tropisetron significantly exceeded the placebo in the assessment of clinical efficacy. ⋯ Adverse events observed were one case of headache in the tropisetron group and one diarrhea in the placebo group, while neither case was serious nor clinically problematic in particular. The above results reveal that tropisetron 5 mg capsule is significantly effective in the treatment of anticancer drug-induced nausea and vomiting. It has also been confirmed that tropisetron is a useful agent without any safety problems.