Table 1.
Investigation scheme in the SYNCHRONOUS trial
| Documentation | Visit 1 | Visit 2 | Visit 2a1) | Visit 3 - 13 | Visit 14 |
|---|---|---|---|---|---|
| Screening | Maximum 2 weeks before start of therapy | 30 days after surgery | q 3 months after V2 | 36 months after V2 | |
| Eligibility criteria | X | ||||
| Baseline data, demographics | X | ||||
| Laboratory analyses | X | ||||
| Tumor markers | X | X | X | ||
| Randomization | X | ||||
| Administered therapies | X | X | X | ||
| Chronic use of analgetic medication | X | X | X | ||
| Assessment of com-plications & safety | X | X | X | ||
| Primary endpoint | X | X | X | ||
| Secondary endpoints | X | X | X | ||
| Quality of life | X | X2) | X | ||
1) Visit 2a will be performed in patients allocated to the experimental arm only. 2) Quality of life will be assessed on V3 (3 months after V2), V4, (6 months) and then every 6 months