Neoadjuvant Chemoradiation in Patients With Borderline Resectable Pancreatic Cancer

• Status: Completed
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Gemcitabine

Criteria

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