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):
Severe adverse events (Yes, No as classified by the CTCAE v4.02 (Common Terminology Criteria for Adverse Events). Measuring time: in every administration during the 5 weeks of treatment.
Key secondary outcomes:
Clinical adverse events (Description of adverse events, event type, body system, identified duration, intensity, outcome, attitude and causation of adverse events). Measuring time: In every administration during the 5 weeks of treatment. Tolerability (subject with adverse events of grade 3 or more according to Common Terminology Criteria for Adverse Events (CTCAE v4.02). Measuring time: In every administration during the 5 weeks of treatment. Laboratory tests (hematologic and biochemical determinations). Measuring time: at baseline, and at week 6. Clinical response (RECIST criteria: Complete response, partial response, stable disease, progressive disease). Measuring time: at baseline, weekly until the 5th week, then at 7, 10, 13 and 16 weeks after starting treatment. Histology: Histology (Absence of tumor, Presence of tumor). Measuring time: at baseline and at 16 weeks. Clinical response time (Time to reach partial or complete response). Measuring time: weekly until the 5th week, then be held in week 7, 10, 13 and 16. Occurrence of relapse: Patients in which appears histologically proven injury in the treated site.Measuring time: annually for 10 years after treatment. Time to recurrence (Time elapsing from the first day provided the absence of neoplastic cells according to the evaluation histological or clinical (patient refusal to biopsy end or biopsy no useful), until appears an injury histologically demonstrated in the treated site. Measuring time: annually for 10 years after treatment.