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Table 1 Inclusion and Exclusion Criteria

From: Clinical phase I/II trial to investigate neoadjuvant intensity-modulated short term radiation therapy (5 × 5 gy) and intraoperative radiation therapy (15 gy) in patients with primarily resectable pancreatic cancer - NEOPANC

Inclusion criteria

Exclusion 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

• 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