Overview

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