Low Dose Radiation to Improve T-Cell Infiltration in Pancreatic Cancer

Randomised Phase I/II Trial in Order to Evaluate the Effect of Neoadjuvant Radiation on Tumor Infiltrating T-cells by Neoadjuvant Low-Dose-Radiation Therapy in Primarily Resectable Pancreatic Cancer

Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximum number of tumor infiltrating T-cells.

Inclusion Criteria:

• Radiological diagnosis of resectable pancreatic carcinoma is required prior to treatment. Potentially resectable is defined as no extrapancreatic disease, no evidence (on CT) of involvement of the celiac axis or superior mesenteric artery, no evidence (on CT or MRI) of occlusion of the superior mesenteric vein or superior mesenteric-portal venous confluence.
• No evidence of metastatic disease as determined by chest CT scan, abdominal CT scan (or MRI)
• 18 years of age or older
• American Society of Anesthesiologists (ASA)- Performance status of 1 to 3
• Women of child bearing potential must practice adequate contraception and refrain from breast feeding. Female patients must have a negative pregnancy test within 7 days of treatment
• Informed consent

Exclusion Criteria:

• Locally irresectable pancreatic cancer
• distant metastases
• medically unfit for surgery
• Pregnant or lactating women
• prior chemotherapy or radiation treatment
• Other serious uncontrolled medical conditions that the investigator feels might compromise study participation
• Unwillingness to participate or inability to comply with the protocol for the duration of the study
• Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery
• Participation in other interventional trials