Status:
COMPLETED
Neoadjuvant Chemoradiation in Patients With Borderline Resectable Pancreatic Cancer
Lead Sponsor:
Seoul National University Hospital
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
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...
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 neoadjuvan...
Eligibility Criteria
Inclusion
- \>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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01458717
Start Date
November 1 2011
End Date
January 1 2018
Last Update
May 2 2018
Active Locations (5)
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1
Center for Liver Cancer, National Cancer Center
Goyang-si, Gyeonggi-do, South Korea, 410-769
2
Seoul National University Bundang Hospital
Seongnam, South Korea, 463-707
3
Seoul National University Hospital
Seoul, South Korea, 110-744
4
Samsung Medical Center
Seoul, South Korea, 135-710