RECIST | RECIST 1.1 | |
---|---|---|
Measurable Disease at BL | Required, MTLS | When required then MTLS, Pats. with non-measurable disease only are allowed |
Minimum Target Lesion Size | ≥10 mm (Spiral CT) ≥20 mm (Conventional CT, MRI) |
≥10 mm (CT + MRI) ≥15 mm Lymph nodes ≥20 mm Chest X-Ray |
No. of measurable Lesions, per organ | 1-10 5 |
1-5 2 |
Measurement | Uni-Dimensional |
Uni-Dimensional Lymph nodes = short axis |
PD |
20 % increase in SLD from Nadir | 20 % increase in SOD + min. 5mm increase from Nadir |
Confirmation of CR and PR |
After at least 28 days |
Only required, if response is primary endpoint and not randomized |
Non Measurable Assessment |
Unequivocal progression |
… substantial worsening, … tumor burden has increased sufficiently |
Lymph node Measurements |
None | Specific instructions ≥15mm, 10-14mm, <10mm |
PET |
Not available |
May be considered to support CT; |