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

Phase 2 Trial to Investigate the Efficacy and Safety of mFOLFIRINOX as Postoperative Chemotherapy for Pancreatic Cancer in Chinese Patients.

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer Resectable
• Intervention / Treatment: Drug: mFOLFORINOX

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-Sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: mFOLFIRINOX; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	the duration from enrollment to the patient's death (all causes)	Up to 24 months

Other Outcome Measures

Outcome Measure	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	Quality of life will be assessed at each study using EORTC QLQ-C30	Up to 24 weeks

Collaborators and Investigators

• Sponsor: Yuhong Li

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: December 6, 2019
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: FOLFIRINOX-PC-Adjuvant

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No