Back to resultsEfficacy and Safety of mFOLFIRINOX as Postoperative Chemotherapy for Pancreatic Cancer in Chinese Patients.
Primary Purpose
Pancreatic Cancer Resectable
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
mFOLFORINOX
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer Resectable
Eligibility Criteria
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.
Sites / Locations
- Sun Yat-sen University Cancer Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
mFOLFIRINOX
Arm Description
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
Outcomes
Primary Outcome Measures
Regression Free Survival
defined as the period from the date of resection to tumor relapse caused by any reason
Secondary Outcome Measures
Overall Survival
the duration from enrollment to the patient's death (all causes)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04224402
Brief Title
Efficacy and Safety of mFOLFIRINOX as Postoperative Chemotherapy for Pancreatic Cancer in Chinese Patients.
Official Title
Phase 2 Trial to Investigate the Efficacy and Safety of mFOLFIRINOX as Postoperative Chemotherapy for Pancreatic Cancer in Chinese Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 31, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yuhong Li
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer Resectable
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mFOLFIRINOX
Arm Type
Other
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
mFOLFORINOX
Intervention Description
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 Measure Information:
Title
Regression Free Survival
Description
defined as the period from the date of resection to tumor relapse caused by any reason
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Overall Survival
Description
the duration from enrollment to the patient's death (all causes)
Time Frame
Up to 24 months
Other Pre-specified Outcome Measures:
Title
adverse events and severe adverse events
Description
number of patients with adverse events and severity according to NCI Common Toxicity Criteria(CTC) 3.0
Time Frame
Up to 12 weeks
Title
EORTC Quality of Life Questionnaire(QLQ)-C30
Description
Quality of life will be assessed at each study using EORTC QLQ-C30
Time Frame
Up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-hong Li
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of mFOLFIRINOX as Postoperative Chemotherapy for Pancreatic Cancer in Chinese Patients.
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