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Neoadjuvant Chemoradiation in Patients With Borderline Resectable Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:
Multicenter Prospective Randomized Phase II/III Study of Neoadjuvant Chemoradiation With Gemcitabine in Patients With Borderline Resectable Pancreatic Cancer

Clinical Trial Summary

Previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline resectable pancreas cancer. This study is a multicenter prospective randomized phase II/III study of neoadjuvant chemoradiation with gemcitabine in patients with borderline resectable pancreas cancer. The study is designed in 2 arms, one with upfront surgery and the other with neoadjuvant chemoradiation therapy.

Clinical Trial Description

Previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline resectable pancreas cancer.

This study is a multicenter prospective randomized phase II/III study of neoadjuvant chemoradiation with gemcitabine in patients with borderline resectable pancreas cancer. The study is designed in 2 arms, one with upfront surgery and the other with neoadjuvant chemoradiation therapy.

This phase 2/3 multicenter randomized controlled trial was designed to enroll 110 patients with BRPC who were randomly assigned to gemcitabine-based neoadjuvant chemoradiation treatment (54 Gray external beam radiation) followed by surgery or upfront surgery followed by chemoradiation treatment from four large-volume centers in Korea. The primary endpoint was the 2-year survival rate (2-YSR). Interim analysis was planned at the time of 50% case enrollment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01458717
Study type Interventional
Source Seoul National University Hospital
Contact
Status Completed
Phase Phase 2/Phase 3
Start date November 2011
Completion date January 2018
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