Neoadjuvant Chemoradiation in Patients With Borderline Resectable Pancreatic Cancer

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

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.

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