Study of Neoadjuvant Treatment in Patients With Pancreatic Cancer That is Potentially Resectable
Study of Neoadjuvant Treatment in Patients With Pancreatic Cancer That is Potentially Resectable
Phase II study of neoadjuvant treatment with Gemcitabine, Tarceva and Oxaliplatin followed by
 chemotherapy with Tarceva and Gemcitabine in patients with pancreatic adenocarcinoma with
 borderline resectability. The primary objective is to determine the resectability rate of
 patients with pancreas adenocarcinoma with borderline resectability determined
 radiologically, treated with Gemcitabine, Tarceva and Oxaliplatin followed by radiotherapy
 with Gemcitabine and Tarceva.
Patients with borderline resectable pancreatic adenocarcinoma are more likely to develop
 perioperative complications due to the complexity of surgery. In these patients there is also
 an increased risk of systemic relapse due to the advanced stage of the tumor as well as a
 higher possibility of having positive margins. Therefore, the treatment of these patients
 need to be decided based on a multidisciplinary strategy. Besides of that the use of systemic
 neoadjuvant chemotherapy as induction therapy, followed by sequential chemoradiotherapy is a
 very attractive therapeutic modality.

 The neoadjuvant treatment offers the potential advantages of reducing the tumor stage,
 increasing resectability and decreasing postoperative complications.

 The administration of chemotherapy and radiotherapy before surgery represent an strategy for
 early treatment of micrometastatic disease, present in most of these patients, and to
 identify patients with rapid progression of the disease.

 For all the reasons above, the investigators consider it's of great interest to design new
 studies that combine systemic neoadjuvant chemotherapy followed by chemoradiotherapy with
 neoadjuvant intention in patients with pancreas cancer locally advanced.
Inclusion Criteria:

 -  Before the beginning of the specific protocol procedures must be obtained and
 documented a written consent form. Patients must have sufficient capacity to
 understand and sign the consent form.

 -  Exocrine pancreatic potentially resectable carcinoma, histologically confirmed.

 -  Aged 18-75 years.

 -  OMS functional state (FE) from 0-2 and Karnofsky functional state 70%.

 -  Radiologically or measurable disease, defined as borderline resectability disease.

 -  Appropriate biological parameters: neutrophils > 1.500/mL; platelets > 100.000/mL;
 hemoglobin > 10 g/dl.Serum creatinine < 1,5 x upper limit of normal (LSN); alkaline
 phosphatase < 3 x LSN and bilirubin < 1,5 x LSN; AST and ALT 2,5 x LSN.

 -  Controlled biliary obstruction in all the patients before their inclusion in the
 study.

 -  Absence of peripheral neuropathy grade 2.

 -  Life expectancy of at least 3 months.

 Exclusion Criteria:

 -  Previous administration of chemotherapy, radiotherapy or any investigational agents
 for pancreatic cancer treatment.

 -  Administration of other experimental treatment during this study or in the previous 6
 months.

 -  Pregnancy, inappropriate or unsafe use of contraceptive methods or women who are
 breast-feeding.

 -  Clinically significant heart disease(for example: congestive heart failure,
 symptomatic coronary artery disease and cardiac arrhythmias not properly controlled
 with medication or myocardial infarction in the last 12 months).

 -  Presence of significant ophthalmologic anomaly, included: severe dry eye syndrome,
 Sjogren syndrome, dry keratoconjunctivitis, severe exposure keratopathy, conditions
 that might increase the risk of epithelium complications.

 -  Patients with lack of physical integrity of the upper gastrointestinal tract or bad
 absorption syndromes or unable to ingest the tablets.

 -  Other previous bad or concurrent diseases, with the exception of nonmelanoma skin
 cancer.

 -  Medical or psychiatric pathologies that are severe or uncontrolled.

 -  Distant metastases.