EOPA: Sequential NEOadjuvant chemoradiotherapy (CRT) followed by curative surgery vs. primary surgery alone for resectable, non-metastasized Pancreatic Adenocarcinoma

Not Applicable

Completed

• Conditions: Biopsy-proven, non-metastasized, adenocarcinoma of the pancreatic head/uncinate process larger than 2 cm in size (=cT2) and/or in close contact with the mesenterico-portal axis and superior mesenteric artery (SMA) (less than 3 mm).; Cancer; Malignant neoplasm of pancreas

• Registration Number: ISRCTN82191749
• Lead Sponsor: niversity Hospital Hamburg-Eppendorf (Germany)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-11
• Study Completion: 2020-01-16
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 410

Inclusion Criteria

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

Exclusion Criteria

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)
11. Chronic infectious diseases, especially immune deficiency syndromes, e.g. HIV infection, active tuberculosis within 12 months prior to potential study participation
12. History of severe neurologic disorders, e.g. cerebrovascular ischemia
13. History of prior deep venous thrombosis or pulmonary embolism
14. Pregnant or nursing women are ineligible and patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months following the trial
15. Serious medical, psychological, familial, sociological or geographical conditions or circumstances potentially hampering compliance with the study protocol and follow-up
16. Participation in other clinical trials during the last 6 months before allocation to trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified