Neoadjuvant Treatment in Resectable Pancreatic Cancer

Summary

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

Conditions

• Pancreatic Cancer

Interventions

RADIATION

External Beam Radiation

Neoadjuvant CRT with external beam radiation (EBRT) delivering a total dose of 50.4 Gy over 28 days in 1.8 Gy fractions.

DRUG

Gemcitabine neoadjuvant

weekly Gemcitabine 300mg/m2 for 6 weeks neoadjuvant

PROCEDURE

Surgery

Upfront pancreato-duodenectomy

DRUG

Gemcitabine adjuvant

Postoperative adjuvant Chemotherapy preferentially using Gemcitabine (1000 mg/m2 6 cycles at day 1, 8, 15 of each 28-day cycle. Administered in both arms, experimental AND active comparator

Sponsors & Collaborators

• University Hospital Schleswig-Holstein

  collaborator OTHER

• Hannover Medical School

  collaborator OTHER

• St. Josef Hospital Bochum

  collaborator OTHER

• University of Jena

  collaborator OTHER

• SRH Wald-Klinikum Gera GmbH

  collaborator OTHER

• Klinikum Darmstadt

  collaborator OTHER

• Universität des Saarlandes

  collaborator OTHER

• Heidelberg University

  collaborator OTHER

• Staedtisches Klinikum Karlsruhe

  collaborator OTHER

• University Hospital Freiburg

  collaborator OTHER

• University Hospital Regensburg

  collaborator OTHER

• Technical University of Munich

  collaborator OTHER

• University Hospital Augsburg

  collaborator OTHER

• Klinikum Stuttgart

  collaborator OTHER

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• University of Rostock

  collaborator OTHER

• Universitätsklinikum Hamburg-Eppendorf

  lead OTHER

Principal Investigators

• Jakob R Izbicki, MD, FACS · Universitätsklinikum Hamburg-Eppendorf

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-02-28

Primary Completion

2016-11-22

Completion

2017-07-31

Countries

• Germany

Study Locations