RecruitingPhase 2NCT04084496

mFOLFIRINOX as Adjuvent Chemotherapy in Treating Chinese Pancreatic Cancer Patients

A Phase II Study With mFOLFIRINOX as Adjuvent Chemotherapy for Resectable Pancreas Carcinoma

Sponsor

Sun Yat-sen University

Enrollment

80 participants

Start Date

Sep 1, 2019

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer

Summary

Although FOLFIRINOX regimen was recently presented to be effective as adjuvant chemotherapy for resectable pancreatic cancer in selected patients who have good physical condition, there is still insufficient evidence on this regimen in treating resectable pancreatic cancer patients in China. Since for many tumors, different races may show different responses to the same regimen, we design this open phase Ⅱ study to evaluate the the efficacy and safety of mFOLFIRINOX as adjuvant chemotherapy for resectable pancreatic cancer in China.

Eligibility

Min Age: 18 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a chemotherapy combination called mFOLFIRINOX as a treatment given after surgery for pancreatic cancer in Chinese patients. The goal is to kill any remaining cancer cells and reduce the chance of the cancer coming back. **You may be eligible if...** - You have been diagnosed with pancreatic cancer (adenocarcinoma) confirmed by biopsy, without spread to distant organs - You have had surgery to remove the pancreatic cancer - You have not received chemotherapy before - You are between 18 and 79 years old - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if...** - You are pregnant or breastfeeding - The cancer has spread to other parts of your body - You have severe bleeding from your digestive system - You are allergic to any of the drugs in this regimen (oxaliplatin, irinotecan, leucovorin, or 5-FU) - You have uncontrolled heart, lung, liver, or kidney disease - You have HIV - You have had another cancer in the past 5 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFolfirinox

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.