Abraxane and Gemcitabine Versus Gemcitabine Alone in Locally Advanced Unresectable Pancreatic Cancer.

Quality of Response

All patients must be considered in response analysis, including those who discontinue treatment or who die for any reason prior to response evaluations

Time frame: Response to treatment is evaluated according to the RECIST criteria at the end of chemotherapy

Esplore the effects of nab-paclitaxel in terms of toxicity

Treatment-emergent adverse events, drug-related adverse events and safety laboratory parameters will be analysed by treatment groups and CTCAE grade

Time frame: every 3 cycles of chemotherapy

Progression Free Survival

Progression free survival time will be defined as the time from randomization until the date of first observed disease progression (radiological or clinical, whichever is earlier) or death due to any cause, if death occurs before progression is documented. Patients who did not progress will be censored at the last date they were known to be alive. Patients who died of disease and for whom a date of progression is not available will be considered to have progressed on the day of their death

Time frame: time from the start of the treatment until PD or death

Overall Survival

Overall survival time will be defined as the time from randomization to the date of death. If the subject has not died, survival will be censored on the last date the subject was known to be alive (last date of follow up).

Time frame: the time from randomization to the date of death