Alternating gemcitabine + nab-paclitaxel and modified FOLFIRINOX for borderline resectable pancreatic cancer
24BRO681 : Neoadjuvant Therapy With Alternating Gemcitabine Plus Nab-Paclitaxel and mFOLFIRINOX for Borderline Resectable Pancreatic Adenocarcinoma: A Phase 2 Clinical Trial
This trial will try alternating two chemotherapy regimens, gemcitabine with nab-paclitaxel and modified FOLFIRINOX, before surgery for people with borderline resectable pancreatic adenocarcinoma.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dartmouth-Hitchcock Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Lebanon, New Hampshire) |
| Trial ID | NCT07043270 on ClinicalTrials.gov |
What this trial studies
This Phase 2 study gives alternating cycles of gemcitabine plus nab-paclitaxel (GnP) and modified FOLFIRINOX as neoadjuvant therapy for patients with borderline resectable pancreatic adenocarcinoma. Patients are staged with contrast-enhanced CT and surgical resectability is confirmed by a multidisciplinary tumor board prior to enrollment. The trial monitors tumor response, safety, and whether alternating regimens increases the chance of successful surgical removal. Participants must have good performance status and no prior chemotherapy or radiation for pancreatic cancer.
Who should consider this trial
Good fit: Adults (≥18) with borderline resectable pancreatic adenocarcinoma confirmed by a GI tumor board, ECOG 0–1, no prior chemo/radiation for PDAC, and willing/able to consent and attend Dartmouth-Hitchcock visits are ideal candidates.
Not a fit: Patients with metastatic or clearly resectable disease, prior pancreatic chemo/radiation, known DPYD poor metabolizer status, or known BRCA1/2 or PALB2 mutations are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, alternating these two active regimens could shrink tumors more effectively to increase the likelihood of successful surgery and lower recurrence risk.
How similar studies have performed: Both GnP and mFOLFIRINOX are established neoadjuvant regimens with demonstrated activity, but alternating the two as a neoadjuvant strategy is relatively novel with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lebanon, New Hampshire
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (Recruiting)
Study contacts
- Study coordinator: Cancer Research Nurse
- Email: cancer.research.nurse@hitchcock.org
- Phone: 800-639-6918
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.