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 randomization until death from any cause). Measurement time: monthly for 3 years.
Key secondary outcomes:
1. Progression Free Survival-PFS (Time from randomization to progression or death from any cause). Time to measurement: every 3 months for 3 years.
2. Time to progression-TTP (Time from randomization until objective tumor progression). Time to measurement: every 3 months for 3 years.
3. Time to appears symptoms (Time from the start of treatment until the date in which any of the following symptoms appear: Pain, worsening of quality of life (according to scales defined in the protocol) and, development of urinary or digestive symptoms related to the underlying disease indicative of commitment of the urinary or digestive tracts respectively). Time to measurement: every 3 months for 3 years.
4. Objective response (Complete response, Partial Response, Stable Disease, Progressive disease). Time to measure: every 3 months for 3 years.
5. Immunological Response (titer of anti-egf antibodies). Time to measurement: every 2 weeks during the 4 induction doses; monthly for 3 years.
6. Drug requirements (Analgesics, Opioids, Bisphosphonates). Time to measurement: at baseline, monthly for 3 years.
7. Immunogenicity (Good antibody response, Super good antibody response, Poor antibody response). Every 2 weeks during the 4 induction doses; monthly for 3 years.
8. IgG Subclass: (Type of IgG). Time to measurement: Every 2 weeks during the 4 induction doses; monthly for 3 years.
9. Immunodominance of the response against EGF (Cellular subpopulation phenotype in peripheral blood). Time to measurement: at baseline, every 3 months for 3 years.
10. Plasmatic EGF concentration (EGF concentration). Time to measurement: Every 2 weeks during the 4 induction doses; monthly for 3 years.
11. Urine EGF concentration. (EGF concentration). Time to measurement: Every 2 weeks during the 4 induction doses; monthly for 3 years.
12. Quality of life (EORTC QLQ-C30 and EORTC QLQ-PR25). Time to measurement: at baseline, every 3 months for 3 years.
13. Adverse Events (AE). (Measurable by: -Occurrence of any AE (Yes, No) -Description of the AE (Name of the adverse events) - -Intensity of the AE (Mild, Moderate, Severe, Extremely Severe, Death) -Severity (Serious, No serious) -Result (Recovered, Enhanced, Persists or squeals) -Attitude towards treatment (Unchanged, Dose modification, Temporary interruption, Definitive interruption) -Causality relationship (Very Likely, Probable, Possible, Unlikely, not related, Unknown)). Time to measurement: monthly during 3 years.