Clinical trial NCT04224402: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer Resectable
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Regression Free Survival
timeFrame: Up to 24 months
Secondary outcomes:
measure: Overall Survival
timeFrame: Up to 24 months
Other outcomes:
measure: adverse events and severe adverse events
timeFrame: Up to 12 weeks
measure: EORTC Quality of Life Questionnaire(QLQ)-C30
timeFrame: Up to 24 weeks
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Yu-hong Li
role: PRINCIPAL_INVESTIGATOR
References: