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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.
The patients will be treated with systemic FOLFIRINOX chemotherapy of adjusted dosage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mFOLFIRINOX | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mFOLFORINOX | Drug | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | the duration from enrollment to the patient's death (all causes) | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events and severe adverse events | number of patients with adverse events and severity according to NCI Common Toxicity Criteria(CTC) 3.0 | Up to 12 weeks |
| EORTC Quality of Life Questionnaire(QLQ)-C30 |
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.
ECOG scored as 0-1.
Life expectancy > 3 months.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yu-hong Li | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
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|
Quality of life will be assessed at each study using EORTC QLQ-C30
| Up to 24 weeks |