Neoadjuvant Chemoradiation in Patients With Borderline Resectable Pancreatic Cancer

Phase 2

Completed

Brief 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.

Detailed 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.

Recruitment & Eligibility

Inclusion Criteria

>18 years old or <75 years old
ECOG 0-2
biopsy proven adenocarcinoma of the pancreas
no history of previous chemotherapy
borderline resectable pancreas cancer
no distant metastasis
WBC at least 3,000/mm3 or absolute neutrophil count at least 1,500/mm3, Platelet count at least 125,000/mm3
Bilirubin less than 2.5 mg/dL AST less than 5 times upper limit of normal
Creatinine no greater than 1.5 times upper limit of normal
informed consent

Exclusion Criteria

history of previous chemotherapy
history of radiation at >25% area of bone marrow
stage unspecified, with distant metastasis, recurrent pancreas cancer
history of malignant neoplasm (except stage 0 cancer, skin in situ cancer except malignant melanoma). Patients who are NED after 5 years after treatment of malignant neoplasm can be candidate of this study
pregnant, breast-feeding patient
uncontrolled or active infection
uncontrolled cardiopulmonary disease

Arm && Interventions

Group	Intervention	Description
Neoadjuvant	Neoadjuvant chemoradiation	Neoadjuvant - operation - maintenance chemotherapy
Upfront surgery	Upfront surgery	Operation - adjuvant chemoradiation - maintenance chemotherapy

Primary Outcome Measures

Name	Time	Method
2-year survival rate	2-year actual survival outcome	2-year actual survival outcome

Secondary Outcome Measures

Name	Time	Method
Median survival	after at least of 2-years follow up of all participants	calculated from overall survival with Kaplan-Meier method
1-year survival rate	after at least of 1-year follow up of all participants	1-year actual survival rate
local recurrence	within at least 2-years follow up	any point during the follow-up period
response rate after neoadjuvant chemoradiation	within 6 weeks after completion of neoadjuvant chemoradiation	comparison of imaging study findings at pre- and post-neoadjuvant chemoradiation
efficacy of imaging study after neoadjuvant chemoradiation	within 3 weeks after operation	comparison of pathology report and imaging study in patients who completed neoadjuvant chemoradiation
R0 resection rate	within 3 weeks after operation	according to pathology report after operation
curative resection rate	within 3 weeks after operation	according to pathology report after operation

Locations (5): Samsung Medical Center
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Seoul, Korea, Republic of
Gangnam Severance Hospital
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Seoul, Korea, Republic of
Seoul National University Hospital
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Seoul, Korea, Republic of
Center for Liver Cancer, National Cancer Center
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Goyang, Gyeonggi, Korea, Republic of
Seoul National University Bundang Hospital
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Seongnam, Korea, Republic of