
| 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; | 
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