Clinical Phase I/II Trial to Investigate Neoadjuvant Intensity-Modulated Short Term Radiation Therapy (5x5 Gy) and Intraoperative Radiation Therapy (15 Gy) in Patients With Primarily Resectable Pancreatic Cancer - NEOPANC
Inclusion Criteria:
- written informed consent
- histologically confirmed, primary pancreatic cancer of the pancreatic head
- judged as gross completely resectable
- absence of lymph node metastases at the splenic hilum or along the pancreatic tail
- no evidence of distant metastases
- age > 50 years
- Karnofsky performance score ≥ 70%
- adequate bone marrow function (neutrophils > 2000/µl, platelets > 100000/µl)
- adequate renal function (Creatinine < 1.5 mg/dl)
- adequate liver function
Exclusion Criteria:
- missing written informed consent
- missing histological conformation of pancreatic cancer
- judged as gross incomplete or not resectable
- pancreatic cancer located in the pancreatic corpus or tail
- recurrent pancreatic cancer
- incomplete staging
- presence of lymph node metastases along the pancreatic tail or splenic hilum
- presence of distant metastases
- prior radiation therapy to the upper abdominal region
- neoadjuvant chemotherapy or immunotherapy
- participation in another clinical interventional study
- age ≤ 50 years
- other previous or active malignancy (excluding basal cell carcinoma, carcinoma in
situ of the cervix)
- Karnofsky performance score <70%
- inadequate bone marrow function
- inadequate renal or liver function
- any other disease or situation, which generally prohibits the use of major surgery or
radiation therapy according to the judgement of a surgeon or radiation oncologist
- inability to participate in regular follow up
- pregnancy, inability or incompliance for adequate contraception
- missing ability to give informed consent
- legal custody