eoadjuvant chemoradioation for resectable, non-metastasized ductal adenocarcinoma of the pancreas
- Conditions
- C25.0Head of pancreas
- Registration Number
- DRKS00003893
- Lead Sponsor
- niversitätsklinikum Hamburg-Eppendorf
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 410
•Histology-proven adenocarcinoma of the pancreatic head/uncinate process with a tumor size greater 2 cm (=cT2) and/or close contact to the superior mesenteric vessels (=3 mm in preoperative staging).
•No evidence of metastasis to distant organs (liver, peritoneum, lung, others).
•For determination of resectability, a multi-detector CT (MDCT) with at least 16 rows applying both oral and intravenous contrast media is performed. MDCT-based imaging focuses on the upper abdomen with native, arterial, and parenchyma phase, where the parenchyma phase should include the pelvis. Imaging criteria derived from the recent consensus definition of the Society of Surgical Oncology, the American Society of Clinical Oncology and the American Hepato-Pancreatico-Biliary Association are applied for preoperative assessment of local resectability.
•Potential Resectability: visualizable fat plane around celiac and superior mesenteric arteries, and patent superior mesenteric/portal vein (SMV/PV).
•Borderline Resectability: substantial superior mesenteric/portal vein impingement, tumor abutment on the SMA < 180°, GDA encasement up to the origin of the hepatic artery, or colonic/mesenteric root invasion.
•Karnofsky performance status = 80%
•Serum creatinine level = 3.0 mg/dl
•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 clinical and laboratory signs of severe cholangitis take place. Patients with serum total bilirubin level > 10.0 mg/dl undergo preoperative biliary decompression, preferentially by interventional endoscopy)
•White blood cell count > 3.5 x 109/ml, platelet count > 100 x 109/ml
•Ability to understand and willingness to consent to formal requirements for study participation
•Written informed consent
•Age < 18 years
•Neuroendocrine, acinar cancer
•Cancers of the pancreatic body or tail, i.e. lesions left to the SMV
•Recurrent disease
•Infiltration of extrapancreatic organs (except duodenum and transverse colon)
•Persistent cholestasis/cholangitis despite adequate biliary stenting
• Distant metasasis
•High-grade therapyresistant stenotic gastric outlet obstruction, especially in the event of endoscopically evidenced tumor invasion into the gastroduodenal mucosa.
•Tumor specific pre-treatment
•History of gastrointestinal perforation, e.g. perforated colonic diverticulitis, abdominal abscess or intestinal fistula within 6 months prior to potential study participation
•Radiographic evidence of severe portal hypertension/cavernomatous transformation that may, at the discretion of the participating investigators, hamper surgery
•Other concurrent malignancies except for basal cell cancer of the skin and in-situ cervical cancer
•Premalignant hematologic disorders, e.g. myelodysplastic syndrome
•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)
•Chronic infectious diseases, especially immune deficiency syndromes, e.g. HIV infection, active tuberculosis within 12 months prior to potential study participation
•Severe neurologic disorders, e.g. cerebrovascular ischemia
•History of prior deep venous thrombosis or pulmonary embolism
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
•Serious medical, psychological, familial, sociological or geographical conditions or circumstances potentially hampering compliance with the study protocol and follow-up
•Participation in other clinical trials during the last 6 months before allocation to trial
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival time (3-year survival rate)
- Secondary Outcome Measures
Name Time Method 1.Histology-proven R0 resection rate based on a standardized histopathological handling of the surgical specimen.<br>2.Frequency of moderate and severe toxicity events and drop-out rate due to therapy related toxicity (NCI Common Toxicity Criteria v4.0)<br>3.Resectability rate (Note: includes both R0 and R1 resection status)<br>4.Rate of unexpected intraoperative irregularities, operative time, blood transfusion requirement, postoperative morbidity rate, especially that of pancreatic fistula, and mortality rate <br>5.Rate of patients with severe postoperative complications (postop. recovery > 8 weeks) rendering adjuvant treatment worthless<br>6.Disease progression during neoadjuvant therapy<br>7.Quality of life analysis (EORTC QLQ C30 questionnaire). After completion of neoadj. RCTx, postoperative, 6, 12 and 18 months after completion of therapy.<br>8.Median disease-free survival (DFS, local and distant), overall survival (OS) (3-year follow-up)<br>9.First site of tumor recurrence<br>