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Tumor Subtypes in Subjects on FOLFIRINOX With Non-Metastatic Pancreatic Cancer

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv10
  2. Eligibility criteria shortened, about 90 wordsv9
  3. 2 versions Re-verified since Jan 5, 2024, no change to tracked fieldsv7-v8
  4. Primary completion date: Dec 2022 to Jul 2027
    • Study completion date: Dec 2025 to Jan 2030
    v6
  5. Site contact updatedv5
Show 3 earlier versionsHide 3 earlier versions
  1. 2 versions Re-verified since May 22, 2020, no change to tracked fieldsv3-v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2019 to Jun 12, 2019
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03977233
Lead Sponsor UNC Lineberger Comprehensive Cancer Center
Conditions
(from sponsor)		 Pancreatic Ductal Adenocarcinoma (PDAC), Cancer of Pancreas, Pancreatic Cancer, Adult, Pancreas Adenocarcinoma, Pancreatic Neoplasms, Pancreatic Cancer Non-resectable, Pancreatic Cancer Resectable
Related terms Pancreatic cancer, adult, Pancreatic Neoplasms
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov