FOLFIRINOX Chemotherapy for Metastatic Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
Surgical Resection of Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma (PHOLIPANC). This is an interventional, open-label, non-randomised, single-arm phase II clinical trial.Eligible patients with hepatic or pulmonary oligometastatic adenocarcinoma of the pancreas must have received neoadjuvant FOLFIRINOX chemotherapy in cycles of 14 days, or other clinically indicated alternative. FOLFIRINOX is not a study treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it does allow patients who are already on FOLFIRINOX or modified FOLFIRINOX to continue, as long as they haven't had more than two treatments.
Is FOLFIRINOX chemotherapy generally safe for humans?
FOLFIRINOX chemotherapy has been shown to be effective but can cause serious side effects like neutropenia (low white blood cell count), febrile neutropenia (fever with low white blood cell count), and diarrhea. These side effects are common, so careful monitoring and dose adjustments are often necessary to manage them safely.12345
How is the FOLFIRINOX drug different from other treatments for metastatic pancreatic cancer?
FOLFIRINOX is unique because it combines four chemotherapy drugs (5-fluorouracil, leucovorin, irinotecan, and oxaliplatin) and is used as a first-line treatment for advanced pancreatic cancer, offering a more aggressive approach compared to other regimens. It is particularly effective for patients with good performance status, meaning they are still relatively healthy despite their cancer.678910
What data supports the effectiveness of the drug FOLFIRINOX for metastatic pancreatic cancer?
Research shows that FOLFIRINOX significantly improves survival and delays cancer progression in patients with metastatic pancreatic cancer compared to the previous standard treatment, gemcitabine. In a study with 342 patients, those treated with FOLFIRINOX lived longer and had a better quality of life, although they experienced more side effects.58111213
Who Is on the Research Team?
Jin He, MD, PhD
Principal Investigator
Johns Hopkins University
Are You a Good Fit for This Trial?
This trial is for adults over 18 with a specific type of pancreatic cancer that has spread to the liver or lungs but hasn't been treated yet. They must have a certain level of physical fitness and measurable disease as per imaging scans reviewed by a qualified radiologist.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Chemotherapy
Participants receive neoadjuvant FOLFIRINOX chemotherapy in cycles of 14 days
Surgical Resection
Eligible patients undergo surgical resection of the primary tumor and metastases
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- FOLFIRINOX
FOLFIRINOX is already approved in European Union, United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor