PAREXEL
Topic 1 | Section 4.3.1

Change 10: Definition of Complete Response (CR)

RECIST 1.0:

  • Lymph nodes with respect to CR not addressed

RECIST 1.1:

  • Target Lesions: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (the sum may not be “0” if there are target nodes)
  • Non-target Lesions: disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (< 10 mm short axis)
    • Non-CR/Non-PD: Persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits