Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Overall Survival: (Time from recruitment until death from any cause). Measurement time: 24 months
Key secondary outcomes:
1. Platelets (Platelets count). Measurement time: At diagnosis, 4 or 6 weeks after first line of chemotherapy and Months 3, 6, 9, 12, 15 and, 18 of treatment.
2. EGF serum concentration (Concentration of EGF in serum). Measurement time: At diagnosis, 4 or 6 weeks after first line of chemotherapy and Months 3, 6, 9, 12, 15 and, 18 of treatment.
3. Immune status of the patient (Percent and absolute value of T CD4+, T CD8+CD28- cells and TCD4/CD8 index, T regulators cells). Measurement time: 4 or 6 weeks after first line of chemotherapy and Months 3, 6, 9, 12, 15 and, 18 of treatment