Modified-FOLFIRINOX Regimen Based Neoadjuvant Therapy in Chinese Patients With Locally Advanced Pancreatic Cancer

Study Overview
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Brief Summary
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FOLFIRINOX regimen is first-line neoadjuvant chemotherapies for patients with locally advanced pancreatic cancer (LAPC) worldwide. However, FOLFIRINOX is not well accepted in China because of the high prevalence of adverse events and poor tolerance. To evaluate the safety and efficacy of modified-FOLFIRINOX (mFOLFIRINOX) in Chinese LAPC patients and compare survival between LAPC patients with mFOLFIRINOX-based preoperative therapy and LAPC patients who underwent surgery alone.

Detailed Description
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At this institution, a mFOLFIRINOX regimen has been adopted for metastatic pancreatic cancer (MPC) patients and promising results obtained. The modification resulted in a significantly reduced prevalence of severe adverse events in MPC patients, whereas the OS and PFS were extended to 10.3m and 7.0m, respectively, which is similar to that for patients on a full-dose regimen. Therefore, the investigators further evaluated the efficacy of mFOLFIRINOX in LAPC patients. Here, investigators want to prospectively enroll LAPC patients who underwent preoperative therapy with mFOLFIRINOX from April 2014 and compared the surgical resectability and surgical morbidity/surgical mortality among patients with surgically resectable pancreatic cancer (RPC) or LAPC who underwent surgery alone retrospectively. For patients with LAPC, mFOLFIRINOX was administrated for several cycles until the optimal response was obtained and then patients were evaluated for surgery. Moreover, survival data, including OS and PFS, were determined.

Official Title
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Modified-FOLFIRINOX Regimen Based Neoadjuvant Therapy in Chinese Patients With Locally Advanced Pancreatic Cancer

Conditions
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Pancreatic Cancer, Chemotherapy Effect, Surgery--Complications

Intervention / Treatment
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* Drug: modified-FOLFIRINOX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients are diagnosed by histology to have pancreatic adenocarcinoma The patients are defined as locally advanced pancreatic cancer according to NCCN guideline The patients prescribed mFOLFIRINOX-based neoadjuvant therapy Exclusion Criteria: ECOG performance score more than 2 Insufficient bone marrow, liver and renal function Patients with other malignancies Patients were older than 85 years or less than 18 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LAPC patients with mFOFLRINOX-based neoadjuvant therapy<br>LAPC patients were enrolled prospectively and diagnosed by MDT group in our hospital. These patients further received the neoadjuvant therapy with mFOLFIRINOX, the Overall survival, Progression survival, response to mFOLFIRINOX, chemo-related Toxicities, Postoperative complications and Histopathologic staging were measured. | Drug: modified-FOLFIRINOX<br>* LAPC patients with mFOLFIRINOX-based neoadjuvant therapy or not was set as the main intervention<br>* Other names: Neoadjuvant therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | the duration from the date of hospital admission to death of any cause. | 2014-04-01 to 2017-11-01 | 
| Progression free survival | the duration from the date of hospital admission to disease progression or death. | 2014-04-01 to 2017-11-01 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to mFOLFIRINOX |  | 2014-04-01 to 2017-11-01 | 
| mFOLFIRINOX related adverse events |  | 2014-04-01 to 2017-11-01 | 
| Postoperative complications |  | 2014-04-01 to 2017-11-01 | 
| Histopathologic staging |  | 2014-04-01 to 2017-11-01 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FOLFIRINOX, Pancreatic cancer, Conversion surgery, Overall survival