NCT07043270 · Dartmouth-Hitchcock Medical Center
24BRO681 : Alternating Gnp and mFOLFIRINOX for BR-PDAC
What this study is about
The purpose of this research is to study the effects and safety of alternating neoadjuvant chemotherapy on borderline resectable pancreatic cancer.
View original scientific description
The purpose of this research is to study the effects and safety of alternating neoadjuvant chemotherapy on borderline resectable pancreatic cancer.
Interventions
DRUG
Nab-paclitaxel + Gemcitabine
Administered ion days 1, 8 and 15 of cycles 1 and 3 (28-day cycles).
DRUG
modified FOLFIRINOX (mFOLFIRINOX)
Administered ion days 1 and 15 of cycles 2 and 4 (28-day cycles).
Primary outcome measures
One-year event-free survival (1y-EFS)
Time frame: I year
One-year EFS is defined as completing one year from enrollment without the occurrence of any of the following events: 1) disease progression per Response Evaluation Criteria in Solid Tumors (RECIST), 2) surgery with R2 resection, 3) recurrent disease following surgery, or 4) death from any cause.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age ≥ 18 years
- Diagnosis of BR-PDAC. The resectability should be officially determined with surgical oncologists at the Dartmouth Cancer Center (DCC) GI multidisciplinary Tumor Board based on NCCN Guidelines Version 2.2024 Pancreatic Adenocarcinoma.
- Patients must be able and willing to provide informed consent.
- Contrast-enhanced CT scan of the chest, abdomen, and pelvis performed within 45 days before registration.
- ECOG Performance Status: 0-1.
- Females of childbearing potential must have a negative pregnancy test done ≤ 14 days prior to study enrollment, and must agree to use a highly effective method of contraception throughout the course of protocol therapy.
Exclusion criteria
- Any prior receipt of chemotherapy or radiation therapy for PDAC.
- Known DPYD poor metabolizer genotype.
- Known BRCA1/2 or PALB2 mutations. If they are found to have BRCA1/2 or PALB2 mutation after inclusion to the trial, the participant will be taken off of protocol therapy (since platinum-containing therapy is preferred for these patients).
- Any confirmed second malignancy that is likely to require systemic therapy during the study period, in the opinion of the enrolling investigator.
- Any of the following baseline laboratory abnormalities:
- Absolute neutrophil count (ANC) \< 2,500/mm3
- Platelet count \< 100,000/mm3
- Hemoglobin \< 7 g/dL
- Creatinine \> 1.5 x upper limit of normal (ULN)
- Total bilirubin \> 1.5 x ULN
- AST/ALT \> 5 x ULN
- Any peripheral sensory neuropathy that meaningfully impairs performance of instrumental activities of daily living, as evaluated by the enrolling investigator.
- Patients who are unable to provide informed consent.
- Patients who are pregnant or breastfeeding.
- Patients who are incarcerated.
Where
- Lebanon, New Hampshire
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 20, 2025 · Source of record for eligibility and locations