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2011-11
2018-01
2018-01
58
NCT01458717
Seoul National University Hospital
Seoul National University Hospital
INTERVENTIONAL
Neoadjuvant Chemoradiation in Patients With Borderline Resectable Pancreatic Cancer
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2011-10-19 | N/A | 2018-04-30 |
2011-10-24 | N/A | 2018-05-02 |
2011-10-25 | N/A | 2018-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Neoadjuvant Neoadjuvant - operation - maintenance chemotherapy | DRUG: Neoadjuvant chemoradiation
|
| ACTIVE_COMPARATOR: Upfront surgery Operation - adjuvant chemoradiation - maintenance chemotherapy | PROCEDURE: Upfront surgery
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 2-year survival rate | 2-year actual survival outcome | 2-year actual survival outcome |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Median survival | calculated from overall survival with Kaplan-Meier method | after at least of 2-years follow up of all participants |
| 1-year survival rate | 1-year actual survival rate | after at least of 1-year follow up of all participants |
| R0 resection rate | according to pathology report after operation | within 3 weeks after operation |
| curative resection rate | according to pathology report after operation | within 3 weeks after operation |
| local recurrence | any point during the follow-up period | within at least 2-years follow up |
| response rate after neoadjuvant chemoradiation | comparison of imaging study findings at pre- and post-neoadjuvant chemoradiation | within 6 weeks after completion of neoadjuvant chemoradiation |
| efficacy of imaging study after neoadjuvant chemoradiation | comparison of pathology report and imaging study in patients who completed neoadjuvant chemoradiation | within 3 weeks after operation |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
