Pancreatic Cancer
Conditions
Keywords
pancreas, cancer, borderline resectable, locally advanced, resectability, chemotherapy, radiation, chemoradiation, neoadjuvant, survival, prognosis, recurrence, response rate
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 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.
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 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.
Interventions
* Neoadjuvant chemoradiation; 45Gy/25fx + 9Gy/5fx of radiation over 6 weeks with Gemcitabine 400mg/㎡ * 4 weeks rest, re-evaluation for resectability * operation * start maintenance chemotherapy within 4\ 6 weeks after operation with Gemcitabine 1000mg/㎡ (D1, 8, 15) every 4 weeks, for 4 cycle
PROCEDUREUpfront surgery
* Operation at time of diagnosis * Adjuvant chemoradiation; 45Gy/25fx + 9Gy/5fx of radiation over 6 weeks with Gemcitabine 400mg/㎡ * start maintenance chemotherapy within 4\ 6 weeks after completion of adjuvant chemoradiation with Gemcitabine 1000mg/㎡ (D1, 8, 15) every 4 weeks, for 4 cycle
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year survival rate | 2-year actual survival outcome | 2-year actual survival outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1-year survival rate | after at least of 1-year follow up of all participants | 1-year actual survival rate |
| R0 resection rate | within 3 weeks after operation | according to pathology report after operation |
| curative resection rate | within 3 weeks after operation | according to pathology report after operation |
| Median survival | after at least of 2-years follow up of all participants | calculated from overall survival with Kaplan-Meier method |
| response rate after neoadjuvant chemoradiation | within 6 weeks after completion of neoadjuvant chemoradiation | comparison of imaging study findings at pre- and post-neoadjuvant chemoradiation |
| efficacy of imaging study after neoadjuvant chemoradiation | within 3 weeks after operation | comparison of pathology report and imaging study in patients who completed neoadjuvant chemoradiation |
| local recurrence | within at least 2-years follow up | any point during the follow-up period |
Countries
South Korea
Outcome results
None listed