Alternating gemcitabine + nab-paclitaxel and modified FOLFIRINOX for borderline resectable pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.