Overview

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