Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Cancer
Sponsor: Wake Forest University Health Sciences
ClinicalTrials ID:NCT05825066
This study is exploring the effects of a specific sequence of chemotherapy drugs, Gemcitabine - Abraxane followed by mFOLFIRINOX, on patients with pancreatic cancer that is difficult to remove surgically or has advanced locally. The aim is to understand the benefits and side effects of this treatment sequence, which is not yet approved by the FDA for this use.
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Program Overview
The purpose of this research is to see how a sequence of chemotherapy drugs, Gemcitabine - Abraxane followed by mFOLFIRINOX, affects patients with pancreatic cancer that is either borderline resectable or locally advanced and cannot be surgically removed. These drugs are already approved for treating advanced pancreatic cancer, but their use in this specific sequence is not yet approved. The study will look at both the positive and negative effects of this treatment on participants and their cancer.
Description
The main goal of this study is to see if using Gemcitabine - Abraxane followed by mFOLFIRINOX can improve the chances of completely removing the cancer through surgery in patients with pancreatic cancer that is difficult to operate on or has advanced locally.
Other goals include:
- Checking the safety and how well patients can tolerate this treatment sequence.
- Measuring how long patients live without the cancer getting worse.
- Evaluating the overall survival of patients receiving this treatment.
- Assessing how well the cancer responds to the treatment.
- Determining the rate at which the disease is controlled with this treatment.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of pancreatic adenocarcinoma, with the main type being adenocarcinoma.
- Cancer must be borderline resectable or locally advanced, as determined by specific guidelines or expert consensus.
- Must be 18 years or older.
- Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Must have adequate organ and bone marrow function, as shown by specific blood test results.
- If jaundice is present, it must be treated, and bilirubin levels must be reduced to 3.0 or lower.
- Must have measurable disease according to specific criteria.
- Must be able to understand and sign a consent form, either directly or through a representative.
Exclusion Criteria
- Have previously received chemotherapy with gemcitabine, nab-paclitaxel, or FOLFIRINOX for pancreatic cancer.
- Are currently receiving other experimental cancer treatments.
- Have had another cancer in the last 3 years, except for certain skin cancers or low-risk prostate cancer.
- Have an active and uncontrolled infection requiring treatment. Patients can join the study if the infection is controlled and treatment is completed.
- Have uncontrolled health issues like heart failure, unstable chest pain, irregular heartbeats, or mental health conditions that could affect study participation or safety.
- Have lung diseases requiring oxygen, like interstitial lung disease or pulmonary fibrosis. Those not needing oxygen are eligible.
- Have had major surgery within 4 weeks before starting the study treatment.
- Are pregnant or breastfeeding.
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