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

Pancreatic Cancer Resectable Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04224402
• Other study ID #: FOLFIRINOX-PC-Adjuvant
• Status: Completed
• Phase: Phase 2
• Start date: January 31, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer Resectable
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Yuhong Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	EORTC Quality of Life Questionnaire(QLQ)-C30	Quality of life will be assessed at each study using EORTC QLQ-C30	Up to 24 weeks
Primary	Regression Free Survival	defined as the period from the date of resection to tumor relapse caused by any reason	Up to 24 months
Secondary	Overall Survival	the duration from enrollment to the patient's death (all causes)	Up to 24 months