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Completed

NCT Number: NCT04224402

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.

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Regression Free Survival

    Time frame: Up to 24 months

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

Secondary outcomes

  1. Overall Survival

    Time frame: Up to 24 months

    the duration from enrollment to the patient's death (all causes)

Other outcomes

  1. adverse events and severe adverse events

    Time frame: Up to 12 weeks

    number of patients with adverse events and severity according to NCI Common Toxicity Criteria(CTC) 3.0

  2. EORTC Quality of Life Questionnaire(QLQ)-C30

    Time frame: Up to 24 weeks

    Quality of life will be assessed at each study using EORTC QLQ-C30

Sponsors and collaborators

Lead sponsor

Yuhong Li

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 13, 2020
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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