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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
* Neoadjuvant chemoradiation; 45Gy/25fx + 9Gy/5fx of radiation over 6 weeks with Gemcitabine 400mg/㎡ * 4 weeks rest, re-evaluation for resectability * operation * start maintenance chemotherapy within 4\~6 weeks after operation with Gemcitabine 1000mg/㎡ (D1, 8, 15) every 4 weeks, for 4 cycle
* Operation at time of diagnosis * Adjuvant chemoradiation; 45Gy/25fx + 9Gy/5fx of radiation over 6 weeks with Gemcitabine 400mg/㎡ * start maintenance chemotherapy within 4\~6 weeks after completion of adjuvant chemoradiation with Gemcitabine 1000mg/㎡ (D1, 8, 15) every 4 weeks, for 4 cycle
Center for Liver Cancer, National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Seoul National University Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
2-year survival rate
2-year actual survival outcome
Time frame: 2-year actual survival outcome
Median survival
calculated from overall survival with Kaplan-Meier method
Time frame: after at least of 2-years follow up of all participants
1-year survival rate
1-year actual survival rate
Time frame: after at least of 1-year follow up of all participants
R0 resection rate
according to pathology report after operation
Time frame: within 3 weeks after operation
curative resection rate
according to pathology report after operation
Time frame: within 3 weeks after operation
local recurrence
any point during the follow-up period
Time frame: within at least 2-years follow up
response rate after neoadjuvant chemoradiation
comparison of imaging study findings at pre- and post-neoadjuvant chemoradiation
Time frame: within 6 weeks after completion of neoadjuvant chemoradiation
efficacy of imaging study after neoadjuvant chemoradiation
comparison of pathology report and imaging study in patients who completed neoadjuvant chemoradiation
Time frame: within 3 weeks after operation
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Gangnam Severance Hospital
Seoul, South Korea