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. 2014 Jun 13;14:427. doi: 10.1186/1471-2407-14-427

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