Neoadjuvant Treatment in Resectable Pancreatic Cancer

• Status: Terminated
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Sequential Neoadjuvant Chemoradiotherapy (CRT) Followed by Curative Surgery vs. Primary Surgery Alone for Resectable, Non-metastasized Pancreatic Adenocarcinoma

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Hannover Medical School; Heidelberg University; Klinikum Augsburg; Klinikum Darmstadt; Klinikum Stuttgart; Ludwig-Maximilians - University of Munich; Saarland University; SRH Wald-Klinikum Gera GmbH; St. Josef Hospital Bochum; Staedtisches Klinikum Karlsruhe; Technische Universität München; Universität des Saarlandes; University Hospital Augsburg; University Hospital Freiburg; University Hospital Regensburg; University Hospital Schleswig-Holstein; University of Jena; University of Rostock; University of Schleswig-Holstein
• Treatments: Gemcitabine

Criteria

Inclusion Criteria:

• 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 [1] 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

Exclusion Criteria:

• 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

• 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

• History of 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