Feasibility of Radiotherapy and Concomitant Gemcitabine and Oxaliplatin in Locally Advanced Pancreatic Cancer and Distal Cholangiocarcinoma

Feasibility of Radiotherapy and Concomitant Gemcitabine and Oxaliplatin in Locally Advanced Pancreatic Cancer and Distal Cholangiocarcinoma

The aim of the study is to evaluate the feasibility defined as overall tolerance and toxicity as well as relative dose-intensity and cumulative dose delivered, of an association ofgemcitabine, oxaliplatin and radiotherapy in patients with locally advanced and unresectable, but non-metastatic pancreatic adenocarcinoma or cholangiocarcinoma

Inclusion Criteria:

• Histologically proven and unresectable adenocarcinoma of the pancreas or cholangiocarcinoma with no evidence of metastatic disease
• WHO performance status of 0 or 1
• Complete recovrey from surgery in case an enteric and/or biliary tract by-pass operation has been performed
• Maximum delay after surgery: 8 weeks
• No previous or co-existent malignant disease except non melanoma skin cancers and adequately treated cervic carcinoma in situ
• Adequate bon marrow reserve
• No previous chemotherapy or radiotherapy
• Expected survival > 6 months

Exclusion Criteria:

• Active infection
• Metastatic disease
• Inadequate liver function after derivative surgery
• Inadequate renal function
• Pregnancy, breast feeding
• Use of any other investigational agent in the month before enrollment
• Patients with grade 2 or more neuropathy