NEOPA - Studie

Multizentrische Studie zur Behandlung des
resektablen Pankreaskarzinoms
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Förderung

Die NEOPA – Studie wird durch die Fördermaßnahme „Klinische Studien“ des
Bundesministeriums für Bildung und Forschung (BMBF) gefördert
link Link .

  APPLICANT/COORDINATING INVESTIGATOR
Prof. Dr. med. E. Yekebas
Prof. Dr. med. J. R: Izbicki

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

STUDY TYPE
Open-label, randomized multicenter phase III study

SAMPLE SIZE
To be assessed for eligibility: n = 600
To be allocated to trial (randomized): n = 410
To be analyzed: approx. 410 patients

TRIAL DURATION
First patient in to last patient out: 72 months
Duration of the entire trial: 78 months
Recruitment period: 36 months

PARTICIPATING CENTERS
To be involved (n): 18
Signed agreement to participate (n): 18

BMBF PROJECT NUMBER
BMBF Nr. 215

SUMMARY
Median OS after surgery in curative intent for non-metastasized pancreas cancer ranges under study conditions from 17.9 months to 23.6 months. Tumor recurrence occurs locally, at distant sites (liver, peritoneum, lungs), or both. Observational and autopsy series report local recurrence rates of up to 87% even after potentially “curative” R0 resection. To achieve better local control, neoadjuvant CRT has been suggested for preoperative tumour downsizing, to elevate the likelihood of curative, margin-negative R0 resection and to increase the OS rate. However, controlled, randomized trials addressing the impact of neoadjuvant CRT survival do not exist. The underlying hypothesis of this randomized, two-armed, open-label, multicenter, phase III trial is that neoadjuvant CRT increases the three-year overall survival by 12% compared to patients undergoing upfront surgery for resectable pancreatic cancer. A rigorous, standardized technique of histopathologically handling Whipple specimens will be applied at all participating centers. Overall, 410 patients (n=205 in each study arm) will be enrolled in the trial, taking into regard an expected drop out rate of 7% and allocated either to receive neoadjuvant CRT prior to surgery or to undergo surgery alone. Circumferential resection margin status, i.e. R0 and R1 rates, respectively, surgical resectability rate, local and distant disease-free and global survival, and first site of tumor recurrence constitute further essential endpoints of the trial.


Kontakt Info: Studiensekretariat der
Klinik und Poliklinik für Allgemein-, Viszeral- und Thoraxchirurgie
Universitätsklinikum Hamburg-Eppendorf - Martinistrasse 52 - 20246 Hamburg
Email: neopa@uke.de - Telefon:040 7410-57061 - Fax:040 7410-56400
uke

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