[Phase II clinical trial of anticancer drugs]

For the evaluation of the therapeutic efficacy of anticancer drugs, we should perform the clinical trials step by step under the protocol with well designed and considered the ethical aspects. In the phase II study, it should determine whether a drug has antitumor activity. In our country, many investigators used the criteria of the Japan society for cancer therapy and also used the criteria made by every society of medical department. It should have a formal registration mechanism for entry. And all patients including the ineligible and incomplete cases (withdrawal and dropouts) should be reported. This is particularly important in the assessment of response rate, because response rate is directly influenced by the numbers of ineligible and incomplete cases. The efficacy is effected by the various prognostic factor and it is necessary to arrange the patients with uniform prognostic factor. The adequate sample size also should be required enough to establish the efficacy of the antitumor activity.