Efficacy and Safety of mFOLFIRINOX as Postoperative Chemotherapy for Pancreatic Cancer in Chinese Patients.

Study Overview
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Brief Summary
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This prospective and open-label study evaluates the efficacy and safety of mFOLFIRINOX as postoperative chemotherapy in treating Chinese patients with pancreatic cancer after R0/R1 resection.

Detailed Description
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The patients will be treated with systemic FOLFIRINOX chemotherapy of adjusted dosage.

Official Title
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Phase 2 Trial to Investigate the Efficacy and Safety of mFOLFIRINOX as Postoperative Chemotherapy for Pancreatic Cancer in Chinese Patients.

Conditions
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Pancreatic Cancer Resectable

Intervention / Treatment
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* Drug: mFOLFORINOX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients should be voluntary to the trial and provide with signed informed consent. Histologically confirmed diagnosis of pancreatic cancer Male or female, Age: 18-79 years old. No recurrence or metastasis was observed from a follow-up of 4 to 8 weeks by CT scan after radical surgery. the value of Carbohydrate Antigen19-9(CA19-9) < 180U/mL within 12 weeks after surgery. No previous chemotherapy Eastern Cooperative Oncology Group(ECOG) performance status of 0-1 normal function of organ system including the followings. No hematologic dysfunction(Platelets ≥90×10^9/L; Neutrophil ≥2×109/L;Hemoglobin ≥90g/L). Serum bilirubin ≤ 1.2 × upper limits of normal(ULN); aminotransferase ≤ 5 × ULN. Serum creatinine ≤ 1.25× ULN, or creatinine clearance rate(CCR) ≥60mL/min(calculated by Cockcroft-Gault formula). ECOG scored as 0-1. Life expectancy > 3 months. Exclusion Criteria: Patient is concurrently using other antineoplastic agent. Known severe hypersensitivity to drugs in the regimen. Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment(with the exception of nonmelanoma skin cancer or cervical carcinoma in situ). Evidence of serious heart disease, including recorded history of congestive heart-failure, uncontrolled serious arrhythmia, angina that needs treatment of drugs, clinical diagnosed cardiac valve disease, history of serious myocardial infarction and intractable hypertension. Evidence of chronic diarrhea(≥4 times/day) or renal dysfunction. Evidence of active infection or active epidemic disease. Psychiatric illness that would prevent the patient from giving informed consent Pregnant or lactating women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: mFOLFIRINOX<br>Patients will receive mFOLFIRINOX every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1; Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion | Drug: mFOLFORINOX<br>* Patients will receive mFOLFIRINOX every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1; Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regression Free Survival | defined as the period from the date of resection to tumor relapse caused by any reason | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | the duration from enrollment to the patient's death (all causes) | Up to 24 months |