Sequential neoadjuvant chemoradiotherapy (CRT) followed by curative surgery vs. primary surgery alone for resectable, non-metastasized pancreatic adenocarcinoma (NEOPA). - NEOPA

niversity Medical Center Hamburg-Eppendorf0 sites410 target enrollmentApril 25, 2013

Conditionson-metastasized, adenocarcinoma of the pancreatic head/uncinate process or body of pancreas that was treated with extended pancreatic head/body resection larger than 2 cm in size (=cT2) and/or in close contact with the mesenterico-portal axis and SMA (less than 3 mm).MedDRA version: 18.1Level: LLTClassification code 10033602Term: Pancreatic adenocarcinoma resectableSystem Organ Class: 100000004864 Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: on-metastasized, adenocarcinoma of the pancreatic head/uncinate process or body of pancreas that was treated with extended pancreatic head/body resection larger than 2 cm in size (=cT2) and/or in close contact with the mesenterico-portal axis and SMA (less than 3 mm).
Sponsor: niversity Medical Center Hamburg-Eppendorf
Enrollment: 410
Status: Active, Not Recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 25, 2013

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

niversity Medical Center Hamburg-Eppendorf

Eligibility Criteria

Inclusion Criteria

•\- Resectable adenocarcinoma of the pancreatic head/uncinate process or body of pancreas that was treated with extended pancreatic head/body resection with a tumor size greater 2 cm (\=cT2\) and/or close contact to the superior mesenteric vessels (\=3 mm in preoperative staging).
•\- Histology/cytology prove OR patients with CT graphical high\-grade suspected adenocarcinoma of the pancreas, CA19\-9 \>100 U/ml, hyperbilirubinemia, B\-symptoms and interdisciplinary decision for therapy
•\- 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

Exclusion Criteria

•\- Age \= 18 years
•\- Neuroendocrine, acinar cancer
•\- Cancers of the pancreatic body or tail (lesions left to the SMV) that were treatd with distal pancreatectomy
•\- 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