Sequential NEOadjuvant chemoradiotherapy (CRT) followed by curative surgery vs. primary surgery alone for resectable, non-metastasized Pancreatic Adenocarcinoma: NEOPA- a randomized multicenter phase III study

niversity Hospital Hamburg-Eppendorf (Germany)0 sites410 target enrollmentFebruary 11, 2014

Overview

2014 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/24906700 protocol (added 09/08/2019)

Registry

who.int

Start Date

February 11, 2014

End Date

January 16, 2020

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity Hospital Hamburg-Eppendorf (Germany)

•1\. Male and female, age 18 years and older
•2\. Histology\-proven, resectable adenocarcinoma of the pancreatic head/uncinate process with a tumor size greater than 2 cm (\=cT2\) and/or close contact to the superior mesenteric vessels (\=3 mm in preoperative staging).
•3\. No evidence of metastasis to distant organs (liver, peritoneum, lung, others).
•4\. Serum creatinine level \= 3\.0 mg/dl
•5\. Serum total bilirubin level \= 3\.0 mg/dl in the absence of biliary obstruction. In the event of biliary obstruction, patients allocated to the CRT group must undergo interventional endoscopy or percutaneous drainage for biliary decompression. Post\-interventionally, bilirubin levels should be \= 3\.0 mg/dl before patients are subjected to CRT. In control patients undergoing upfront surgery, serum total bilirubin levels \= 10\.0 mg/dl are tolerated, unless there are clinical and laboratory signs of severe cholangitis. Patients with serum total bilirubin level \> 10\.0 mg/dl undergo preoperative biliary decompression, preferentially by interventional endoscopy)
•6\. White blood cell count \= 3\.5 x 109/ml, platelet count \= 100 x 109/ml
•7\. Ability to understand and willingness to consent to formal requirements for study participation
•8\. Written informed consent

•1\. Age \= 18 years
•2\. Recurrent disease
•3\. Infiltration of extrapancreatic organs (except duodenum and transverse colon)
•4\. Persistent cholestasis/cholangitis despite adequate biliary stenting
•5\. Gastric outlet obstruction, especially in the event of endoscopically evidenced tumor invasion into the gastroduodenal mucosa.
•6\. Tumor\-specific pre\-treatment
•7\. History of gastrointestinal perforation, e.g. perforated colonic diverticulitis, abdominal abscess or intestinal fistula within 6 months prior to potential study participation
•8\. Radiographic evidence of severe portal hypertension/cavernomatous transformation that may, at the discretion of the participating investigators, hamper surgery
•9\. Other concurrent malignancies except for basal cell cancer of the skin and in\-situ cervical cancer, premalignant hematologic disorders, e.g. myelodysplastic syndrome
•10\. Severe organ dysfunctions (e.g., liver cirrhosis \= Child B; Cardio\-pulmonal diseases (NYHA \=III, arrhythmia Lown III/IV, global respiratory insufficiency); ascites; acute pancreatitis; bleeding diathesis, coagulopathy, need for full\-dose anticoagulation or INR \> 1\.5; other severe diseases that might prevent completion of the treatment regimen)