Neoadjuvant Chemoradiation in Patients With Borderline Resectable Pancreatic Cancer
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
58 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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