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

Phase 2

Completed

• Conditions: Pancreatic Cancer Resectable
• Interventions: Drug: mFOLFORINOX

• Registration Number: NCT04224402
• Lead Sponsor: Yuhong Li

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.

Study Timeline

• Study First Submitted: 2019-12-06
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-13
• Study Start: 2020-01-31
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-13
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mFOLFIRINOX	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Overall Survival	Up to 24 months	the duration from enrollment to the patient's death (all causes)

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China