Efficacy and Feasibility of Combining FOLFIRINOX and Stereotactic Radiotherapy for Patients With Irresectable Locally Advanced Pancreatic Cancer.

Efficacy and Feasibility of Combining FOLFIRINOX and Stereotactic Radiotherapy for Patients With Irresectable Locally Advanced Pancreatic Cancer.

The purpose of this study is to investigate whether combining FOLFIRINOX chemotherapy and stereotactic radiotherapy in patients with locally advanced pancreatic cancer leads to an increase in survival.

Inclusion Criteria:

• Cytological or histologically confirmation of pancreatic cancer.
• WHO performance status of 0 or 1
• ASA classification I or II
• Tumor considered locally advanced after diagnostic work-up including CT-imaging and diagnostic laparoscopy.
• No evidence of metastatic disease
• Largest tumor diameter < 7 cm x 7 cm x 7 cm
• Normal renal function (Creatinine ≥ 30 ml/min).
• Normal liver tests (bilirubin < 1.5 times normal; ALAT/ASAT < 5 times normal)
• Normal bone marrow function (WBC > 3.0 x 10e9/L, platelets > 100 x 10e9/L and hemoglobin > 5.6 mmol/l)
• Age > 18 years and < 75 years
• Written informed consent

Exclusion Criteria:

• Prior radiotherapy, chemotherapy or resection (bypass surgery allowed).
• Lymph node metastases from primary tumor outside the field of radiation.
• Second primary malignancy except in situ carcinoma of the cervix, adequately treated non-melanoma skin cancer, or other malignancy treated at least 3 years previously without evidence of recurrence.
• Pregnancy, breast feeding.
• Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.