Actively Recruiting
Neoadjuvant Therapy With Alternating Gemcitabine Plus Nab-Paclitaxel and mFOLFIRINOX for Borderline Resectable Pancreatic Adenocarcinoma: A Phase 2 Clinical Trial
Led by Dartmouth-Hitchcock Medical Center · Updated on 2025-10-20
35
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects and safety of alternating two neoadjuvant chemotherapy treatments—modified FOLFIRINOX (mFOLFIRINOX) and gemcitabine plus nab-paclitaxel (GnP)—in patients with borderline resectable pancreatic adenocarcinoma. Both treatments are FDA-approved and commonly used, and this study aims to see if alternating them before surgery can improve tumor removal, treatment response, and reduce the chance of cancer returning. Participants will receive these chemotherapy drugs in a specific schedule: GnP is given on days 1, 8, and 15 during cycles 1 and 3 (each cycle lasting 28 days), while mFOLFIRINOX is administered on days 1 and 15 during cycles 2 and 4. This alternating treatment is given before surgery, following recommendations from their treating physician. The study is a phase 2 clinical trial sponsored by Dartmouth-Hitchcock Medical Center. During the study, participants will have imaging scans such as contrast-enhanced CT scans and undergo evaluations of their physical health and tumor response. Researchers will monitor safety, treatment completion, need for dose changes, surgery rates, and survival outcomes over one year. Key measurements include one-year event-free survival and recurrence-free survival after surgery, among others. The total participation length varies but includes assessments before and after chemotherapy and surgery.
CONDITIONS
Brief Title
24BRO681 : Alternating Gnp and mFOLFIRINOX for BR-PDAC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of borderline resectable pancreatic ductal adenocarcinoma confirmed by surgical oncologists based on NCCN guidelines
- Ability and willingness to provide informed consent
- Contrast-enhanced CT scan of chest, abdomen, and pelvis performed within 45 days before registration
- ECOG Performance Status of 0 or 1
- For females of childbearing potential, a negative pregnancy test within 14 days prior to enrollment and agreement to use effective contraception during treatment
You will not qualify if you...
- Prior chemotherapy or radiation therapy for pancreatic ductal adenocarcinoma
- Known DPYD poor metabolizer genotype
- Known BRCA1, BRCA2, or PALB2 mutations; participants found to have these mutations after enrollment will be removed from the study
- Any second malignancy likely to require systemic therapy during the study period
- Baseline laboratory abnormalities: ANC less than 2,500/mm3, platelet count less than 100,000/mm3, hemoglobin less than 7 g/dL, creatinine above 1.5 times the upper limit of normal, total bilirubin above 1.5 times the upper limit of normal, AST or ALT above 5 times the upper limit of normal
- Peripheral sensory neuropathy that significantly impairs daily living activities
- Inability to provide informed consent
- Pregnancy or breastfeeding
- Incarceration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 16 weeks (four 28-day cycles)
Participants receive alternating chemotherapy treatments with Gemcitabine plus Nab-Paclitaxel and modified FOLFIRINOX (mFOLFIRINOX) in 28-day cycles as neoadjuvant therapy.
Multiple treatment visits on days 1, 8, and 15 of cycles 1 and 3; days 1 and 15 of cycles 2 and 4
Trial Site Locations
Total: 1 location
1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
Research Team
C
Cancer Research Nurse
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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