Clinical trial NCT01900327 (phase 3, status: terminated)
Conditions: pancreatic cancer
ICD codes: C25.3
Drugs: gemcitabine neoadjuvant, gemcitabine adjuvant
SMILES: NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
Reason stopped: 
    recruitment failure
  
Eligibility 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