- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2016-05
2019-09
2019-11
44
NCT02749136
Asan Medical Center
Asan Medical Center
INTERVENTIONAL
Neoadjuvant Modified FOLFIRINOX in Borderline Resectable Pancreatic Cancer
The purpose of this study is to assess the feasibility and efficacy outcomes of neoadjuvant modified FOLFIRINOX and postoperative gemcitabine in patients with borderline resectable pancreatic cancer.
Pancreatic cancer is the fourth leading cause of cancer-related death worldwide. The 5-year survival rate in overall patients is less than 6% due to late clinical manifestation and the systemic nature of the disease at presentation. Even in patients with resectable disease, estimated 5-year survival rates after resection are between 15% and 20%. Traditionally, resection alone is regarded as inadequate for cure. Therefore, systemic and/or combined chemotherapy and radiotherapy have been used as preoperative or postoperative therapy. Neoadjuvant treatment offers several theoretical advantages over an initial resection. Early delivery of systemic therapy for all patients which might lead to the higher rates of negative margin resection rate, and enhanced patient selection for surgery. Although neoadjuvant treatment has been established as a standard of care for resectable or locally advanced disease of breast, gastric, and rectal cancers, the role of neoadjuvant treatment in patients with pancreatic cancer is not clear at present. There is no global consensus on the management of patients with borderline resectable pancreatic cancer. If initially resected, postoperative adjuvant chemotherapy or chemoradiotherapy is standard. However, there is no standard regimen for neoadjuvant chemotherapy for pancreatic cancer. Recent pivotal phase 2/3 trial has demonstrated that FOLFIRINOX improved the response rates and survival outcomes of patients with metastatic pancreatic cancer compared to gemcitabine. Because of higher response rates (about 30%) with FOLFIRINOX, this regimen is now widely investigated in the neoadjuvant setting. Therefore, investigators hypothesize that neoadjuvant FOLFIRINOX may enhance the outcomes of patients with borderline resectable pancreatic cancer. This study will assess the feasibility and efficacy outcomes of neoadjuvant modified FOLFIRINOX and postoperative gemcitabine in patients with borderline resectable pancreatic cancer.
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 |
|---|---|---|
2016-04-20 | N/A | 2019-11-22 |
2016-04-20 | N/A | 2019-11-25 |
2016-04-22 | N/A | 2019-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Perioperative chemotherapy * Preoperative mFOLFIRINOX, every 2 weeks, 8 cycles * Postoperative gemcitabine, every 4 weeks, 3-6 cycles | DRUG: Preoperative modified FOLFIRINOX and postoperative gemcitabine
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 1-year progression-free survival (PFS) rate | PFS rate at 1 year | 1 year |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Median PFS | 3 years |
| Overall survival (OS) | Median OS | 3 years |
| Macroscopic complete resection rate | The rate of no gross residual disease after surgery | 5 months |
| Response rate | Response rate defined by Response Evaluation Criteria in Solid Tumor version 1.1 | 4 months |
| Toxicity profile | Adverse events graded by National Cancer Institute Common Terminology Criteria version 4.03 | 1 year |
| Biomarker analysis | Blood-based biomarker analysis for the correlation with response rate, progression-free survival and overall survival | 3 years |
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:
19 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
