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Clinical Trial Record

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

2020-01-31

2022-12-31

2022-12-31

80

Study Overview

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.

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

  • Pancreatic Cancer Resectable
  • DRUG: mFOLFORINOX
  • FOLFIRINOX-PC-Adjuvant

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2019-12-06  

N/A  

2023-02-13  

2020-01-08  

N/A  

2023-02-15  

2020-01-13  

N/A  

2023-02  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/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 continu

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 continu
Primary Outcome MeasuresMeasure DescriptionTime Frame
Regression Free Survivaldefined as the period from the date of resection to tumor relapse caused by any reasonUp to 24 months
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Overall Survivalthe duration from enrollment to the patient's death (all causes)Up to 24 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Yu-hong Li, Sun Yat-sen University

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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