Pancreatic Cancer Resectable
Conditions
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.
Detailed description
The patients will be treated with systemic FOLFIRINOX chemotherapy of adjusted dosage.
Interventions
DRUGmFOLFORINOX
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.
Sponsors
Yuhong Li
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
1. Patients should be voluntary to the trial and provide with signed informed consent. 2. Histologically confirmed diagnosis of pancreatic cancer 3. Male or female, Age: 18-79 years old. 4. No recurrence or metastasis was observed from a follow-up of 4 to 8 weeks by CT scan after radical surgery. 5. the value of Carbohydrate Antigen19-9(CA19-9) \< 180U/mL within 12 weeks after surgery. 6. No previous chemotherapy 7. Eastern Cooperative Oncology Group(ECOG) performance status of 0-1 8. 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). 9. ECOG scored as 0-1. 10. Life expectancy \> 3 months.
Exclusion criteria
1. Patient is concurrently using other antineoplastic agent. 2. Known severe hypersensitivity to drugs in the regimen. 3. 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). 4. 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. 5. Evidence of chronic diarrhea(≥4 times/day) or renal dysfunction. 6. Evidence of active infection or active epidemic disease. 7. Psychiatric illness that would prevent the patient from giving informed consent 8. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regression Free Survival | Up to 24 months | defined as the period from the date of resection to tumor relapse caused by any reason |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Up to 24 months | the duration from enrollment to the patient's death (all causes) |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed