Topic 1 | Section 3.1.3

Change 7: Presence of Measurable Disease at Baseline


  • To assess objective response, it is necessary to estimate the overall tumor burden at baseline to which subsequent measurements will be compared. Only patients with measurable disease at baseline should be included in protocols where objective tumor response is the primary end point. Measurable disease is defined by the presence of at least one measurable lesion. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology.


  • In studies where the primary endpoint is tumour progression, the protocol must specify if entry is restricted to those with measurable disease or whether patients having non-measurable disease only are also eligible.