Nab-paclitaxel + Gemcitabine and mFOLFIRINOX for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effects and safety of a combination of chemotherapy drugs on pancreatic cancer that is difficult to remove surgically. The focus is on using two treatments: Nab-paclitaxel with Gemcitabine and a modified version of FOLFIRINOX (mFOLFIRINOX), administered before surgery to shrink the tumor. Suitable candidates have been diagnosed with borderline resectable pancreatic cancer and have not yet received chemotherapy or radiation treatments. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in pancreatic cancer treatment.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the combination of nab-paclitaxel and gemcitabine is generally well-tolerated by patients with pancreatic cancer. Some studies indicate that this treatment can extend patient survival. While side effects may occur, they are often manageable and similar to those of other cancer treatments.
Modified FOLFIRINOX (mFOLFIRINOX) is another effective and tolerable treatment option. Patients using mFOLFIRINOX often live longer compared to those using treatments like gemcitabine alone. However, like most chemotherapy treatments, it may also have side effects.
Both treatments have demonstrated safety in previous studies for many patients. Individual experiences can vary, so discussing potential side effects with a healthcare provider is important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Nab-paclitaxel, Gemcitabine, and mFOLFIRINOX for pancreatic cancer because it brings together two potent chemotherapy regimens in a new way. Traditional treatments for pancreatic cancer often involve either FOLFIRINOX or Nab-paclitaxel plus Gemcitabine alone. This trial combines them to potentially enhance effectiveness, especially in patients with borderline resectable pancreatic ductal adenocarcinoma. By administering this combination as neoadjuvant therapy, researchers are hopeful it will shrink tumors more effectively before surgery, offering a new strategy to improve surgical outcomes and overall survival rates.
What evidence suggests that this trial's treatments could be effective for pancreatic cancer?
This trial will evaluate the effectiveness of two treatment options for pancreatic cancer: a combination of nab-paclitaxel and gemcitabine, and modified FOLFIRINOX (mFOLFIRINOX). Studies have shown that combining nab-paclitaxel with gemcitabine can extend survival in pancreatic cancer patients. Specifically, one study found that 16% of patients treated with this combination lived for a year without disease progression, compared to 9% of those who received only gemcitabine. Additionally, research indicates that modified FOLFIRINOX can prolong survival more effectively than gemcitabine alone. In one study, patients on modified FOLFIRINOX lived without the disease for about 21.4 months, longer than with other treatments. These findings suggest that both treatment options could be effective for pancreatic cancer.24678
Are You a Good Fit for This Trial?
This trial is for adults over 18 with borderline resectable pancreatic cancer (BR-PDAC), confirmed by a specialized tumor board. Participants must be in good physical condition, not pregnant or breastfeeding, willing to use contraception, and able to consent. They can't have certain blood abnormalities, organ dysfunctions, genetic mutations related to cancer treatment response, prior PDAC treatments, other active cancers needing treatment during the study period or severe neuropathy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Chemotherapy
Participants receive alternating neoadjuvant chemotherapy with Gemcitabine plus Nab-Paclitaxel and mFOLFIRINOX
Radiation
Participants undergo radiation therapy prior to surgery
Surgery
Participants undergo surgery for tumor removal
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- modified FOLFIRINOX (mFOLFIRINOX)
- Nab-paclitaxel + Gemcitabine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dartmouth-Hitchcock Medical Center
Lead Sponsor