Table 1 Primary and secondary endpoints in the EGeSOR trial
Endpoints | Time assessed | Description |
|---|---|---|
Primary endpoint | 6 months after randomisation | Composite criterion including |
- death, | ||
- at least 2-point decrease in the Activities of Daily Living (ADL) score versus baseline | ||
- at least 10% decrease in body weight versus baseline | ||
Secondary endpoints | 6, 12, and 24 months after randomisation | - each component of the primary endpoint |
- progression-free survival | ||
- in-hospital death | ||
- unplanned admissions | ||
- post-surgery hospital stay length | ||
- discharge to home or nursing home | ||
- final cancer treatment plan (surgery, chemotherapy, targeted therapies, radiotherapy, and/or supportive care, alone or combined) | ||
- quality of life assessed by EORTC QLQ-C30 and specific module for head and neck cancer H&N35 | ||
- treatment toxicities and/or complications: chemotherapy toxicities according to Classification Common Terminology Criteria for Adverse Events (CTCAE version 4.02) | ||
- cancer treatment feasibility | ||
- costs |