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

Yuhong Li

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer Resectable

Treatments: Drug: mFOLFORINOX

Study type: Interventional

Funder types: Other

Identifiers

NCT04224402

FOLFIRINOX-PC-Adjuvant

Details and patient eligibility

About

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.

Full description

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

Enrollment: 80 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

mFOLFIRINOX

Other group

Description:

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

Treatment:

Drug: mFOLFORINOX