Randomized Phase II Cancer Clinical Trials (2013)

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A clinical trial is an important research tool in the evaluation of the efficacy and safety of cancer therapies. Cancer therapies include anticancer drugs, gene therapy, surgical procedure, radiation therapy, and combinations of these. An experimental therapy is evaluated through three phases of cancer clinical trials. A phase I trial has the objective of selecting the appropriate dose level of an experimental therapy (mostly an anticancer drug) to be used for further investigation. Once a dose level is chosen, the experimental therapy is tested through a small phase II trial requiring 50 to 100 patients. An experimental therapy that is shown to have a promising activity in phase II is evaluated by a large-scale phase III trial compared to a current standard therapy. Since evaluation of an experimental therapy through these clinical trials is limited to a specific type of disease, a single experimental therapy may go through multiple phase II and III trials for different disease types, especially when it is shown to be very efficacious from earlier trials.

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