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

NCT04224402 | Completed Phase 2

• 1 other identifier: FOLFIRINOX-PC-Adjuvant
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer Resectable

Outcome Measures

Primary Outcomes (1)

• Regression Free Survival

  defined as the period from the date of resection to tumor relapse caused by any reason

  Up to 24 months

Secondary Outcomes (1)

• Overall Survival

  Up to 24 months

Other Outcomes (2)

• adverse events and severe adverse events

  Up to 12 weeks

• EORTC Quality of Life Questionnaire(QLQ)-C30

  Up to 24 weeks

Study Arms (1)

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

Drug: mFOLFORINOX

Interventions

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.

mFOLFIRINOX

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).
• ECOG scored as 0-1.
• Life expectancy \> 3 months.

You may not qualify if:

• Patient is concurrently using other antineoplastic agent.
• Known severe hypersensitivity to drugs in the regimen.
• 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).
• 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.
• Evidence of chronic diarrhea(≥4 times/day) or renal dysfunction.
• Evidence of active infection or active epidemic disease.
• Psychiatric illness that would prevent the patient from giving informed consent
• Pregnant or lactating women.

Sponsors & Collaborators

• Yuhong Li: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Study Officials

• Yu-hong Li

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: January 13, 2020
• Study Start: January 31, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

CN (1)