Study of Induction Chemotherapy Followed by Radiochemotherapy in Locally Advanced Pancreatic Cancer
Study of Induction Chemotherapy Followed by Radiochemotherapy in Locally Advanced Pancreatic Cancer
There is no a clear consensus regarding the optimal treatment of locally advanced pancreatic
 disease. There is a potential role for neoadjuvant therapy to treat micrometastatic disease
 with chemotherapy, as well as for the treatment of local disease with radiotherapy. The
 investigators evaluated the safety and efficacy of induction chemotherapy with oxaliplatin
 and gemcitabine followed by a high weekly dose of gemcitabine concurrent to radiation therapy
 in patients with borderline resectable and unresectable locally advanced pancreatic cancer
Continued optimization in multimodality therapy and an accurate patient selection remain
 crucial points for the appropriate treatment of patients with pancreatic cancer.

 In all patients an accurate pre-treatment staging was performed, including: physical
 examination, complete blood tests and tumor markers, endoscopic ultrasonography (EUS) with
 fine needle aspiration biopsy, multilayer CT scan, PET-CT (positron emission computed
 tomography) with 18F-2-fluoro-2-deoxy-D-glucose (FDG) and laparoscopy with peritoneal
 washing. Jaundiced patients before or during treatment underwent endoscopic biliary stenting.

 Patients with the evidence of metastatic disease were excluded, and thus only a small number
 of patients was consequently enrolled with this neoadjuvant approach.

 The induction phase of the treatment plan was designed to administer gemcitabine 1000 mg/mq
 and oxaliplatin 100 mg/mq every 14 days for four doses.

 In the combined phase of the treatment all patients underwent simulation by using a Siemens
 16-CT simulator (Siemens Medical System). Radiotherapy target volumes were established by CT
 scan and PET-CT scan.

 Four weeks after the completion of radiochemotherapy, restaging, consisting of clinical
 examination, laboratory test, tumor markers, CT scan and PET-CT scan, was performed. Tumor
 response was defined in accordance with the World Health Organization (WHO) definition
 through CT scan and PET-CT scan. Surgery was considered in patients whose tumors were
 technically resectable.

 After resection, patients were evaluated every three months by means of a standard
 surveillance protocol that included history and physical examination, cross-sectional imaging
 and measurement of serum markers, and the intervals were extended to six months after two
 years
Inclusion Criteria:

 -  proven cytological or histological diagnosis of pancreatic ductal adenocarcinoma;

 -  borderline resectable or unresectable pancreatic tumours;

 -  age between 18 and 75 years;

 -  no previous radiochemotherapy to abdomen;

 -  0-I ECOG (Eastern Cooperative Oncology Group) performance status;

 -  adequate cardiac, liver and kidney function and a good bone marrow reserve.

 Exclusion Criteria:

 -  resectable and metastatic disease;

 -  previous or concomitant malignant disease;

 -  one or more of the following clinical conditions: infection, pregnancy or
 breast-feeding, liver failure, kidney failure, Pa O2 < 65 mmHg, Pa CO2 > 40 mmHg,
 mental disability.