[Guidelines of the Working Group on Internal Oncology for drawing up protocols for phase II testing of cytostatic...

A proposal for the composition of chemotherapeutic phase-II-trials from the Phase-II Study Group of the Study Group for Clinical Oncology of the German Cancer Society is herewith presented. The recent international standard is taken into consideration. The master protocol shows the formal aspects of such a study, refers to the relevant and complete representation of the related literature, emphasizes the clear formulation of the introduction and the aim of the study, presents the patient including and excluding criteria, gives a formal proposal for description of the study drugs, the side effects and supportive therapy, the diagnostic procedures and the response criteria. The problems of patient information, documentation and statistics as well as administrative aspects are mentioned.