PAREXEL
Topic 1 | Section 3.1.3

Change 6: Prior Local Treatment of Lesions

RECIST 1.0:

  • Tumor lesions that are situated in a previously irradiated area might or might not be considered measurable, and the conditions under which such lesions should be considered must be defined in the protocol when appropriate.

RECIST 1.1:

  • Tumour lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are usually not considered measurable unless there has been demonstrated progression in the lesion. Study protocols should detail the conditions under which such lesions would be considered measurable.