Efficacy and Safety of mFOLFIRINOX as Postoperative Chemotherapy for Pancreatic Cancer in Chinese Patients.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
The patients will be treated with systemic FOLFIRINOX chemotherapy of adjusted dosage.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: mFOLFIRINOX 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
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.
|
Outcome Measures
Primary Outcome Measures
- Regression Free Survival [Up to 24 months]
defined as the period from the date of resection to tumor relapse caused by any reason
Secondary Outcome Measures
- Overall Survival [Up to 24 months]
the duration from enrollment to the patient's death (all causes)
Other Outcome Measures
- adverse events and severe adverse events [Up to 12 weeks]
number of patients with adverse events and severity according to NCI Common Toxicity Criteria(CTC) 3.0
- EORTC Quality of Life Questionnaire(QLQ)-C30 [Up to 24 weeks]
Quality of life will be assessed at each study using EORTC QLQ-C30
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients should be voluntary to the trial and provide with signed informed consent.
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Histologically confirmed diagnosis of pancreatic cancer
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Male or female, Age: 18-79 years old.
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No recurrence or metastasis was observed from a follow-up of 4 to 8 weeks by CT scan after radical surgery.
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the value of Carbohydrate Antigen19-9(CA19-9) < 180U/mL within 12 weeks after surgery.
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No previous chemotherapy
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Eastern Cooperative Oncology Group(ECOG) performance status of 0-1
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normal function of organ system including the followings.
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No hematologic dysfunction(Platelets ≥90×10^9/L; Neutrophil ≥2×109/L;Hemoglobin ≥90g/L).
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Serum bilirubin ≤ 1.2 × upper limits of normal(ULN); aminotransferase ≤ 5 × ULN.
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Serum creatinine ≤ 1.25× ULN, or creatinine clearance rate(CCR) ≥60mL/min(calculated by Cockcroft-Gault formula).
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ECOG scored as 0-1.
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Life expectancy > 3 months.
Exclusion Criteria:
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Patient is concurrently using other antineoplastic agent.
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Known severe hypersensitivity to drugs in the regimen.
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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).
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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.
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Evidence of chronic diarrhea(≥4 times/day) or renal dysfunction.
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Evidence of active infection or active epidemic disease.
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Psychiatric illness that would prevent the patient from giving informed consent
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Pregnant or lactating women.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | China | 510060 |
Sponsors and Collaborators
- Yuhong Li
Investigators
- Principal Investigator: Yu-hong Li, Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FOLFIRINOX-PC-Adjuvant