Tumor Subtypes in Subjects on FOLFIRINOX With Non-Metastatic Pancreatic Cancer
Status:
Recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
Summary
This is a research study to evaluate how the genetic makeup of Pancreatic Ductal
Adenocarcinoma (PDAC) can affect the response to FDA-approved chemotherapy treatment,
FOLFIRINOX, given before surgery to remove the tumor. Certain types of PDAC tumors can be
surgically resected (removed). However, not all types of PDACs are resectable, especially if
they are close to important structures like blood vessels or intestines. These types of PDACs
are treated with chemotherapy such as FOLFIRINOX. Research studies showed that chemotherapy
after surgical resection of PDAC tumors reduced the risk of the cancer returning.
Chemotherapy is used to treat PDAC that has not spread outside of the pancreas and is not
resectable. FOLFIRINOX is a chemotherapy treatment that combines multiple chemotherapeutic
agents, including oxaliplatin, leucovorin, irinotecan, and 5-FU. Patients receive these
agents by intravenous infusion. Of these drugs, 5-FU requires you to return home with a
chemotherapy pump that will deliver chemotherapy over 46 hours. This regimen has been studied
in pancreatic cancer that has been removed with surgery as a method for preventing the cancer
from returning. Studies showed FOLFIRINOX chemotherapy reduced the risk of cancer returning
and increased patients survival. In this study, researchers want to know if FOLFIRINOX
chemotherapy given before surgery will make the cancer easier to remove with surgery and
increase the chances of the cancer staying away after surgery.
Researchers have shown that pancreatic cancers are not all the same when you look at the DNA
and RNA that is inside a pancreatic cancer cell.
Depending on the expression of different genes in a cancer cell, some pancreatic cancers may
respond differently to chemotherapy. In this study researchers want to know if FOLFIRINOX
chemotherapy can change the genetic profile of the cancer. This will be studied by obtaining
a biopsy of the cancer before the start of chemotherapy, and after 8 treatments of
chemotherapy. They will also study cancer cells that will be collected from blood samples.