Pancreas Adenocarcinoma
Conditions
Keywords
mFOLFIRINOX, Gemcitabine, Nab-Paclitaxel, Neoadjuvant alternating chemotherapy, Resectable Pancreatic cancer, BR-PDAC, Pancreatic Cancer
Brief summary
The purpose of this research is to study the effects and safety of alternating neoadjuvant chemotherapy on borderline resectable pancreatic cancer.
Detailed description
Modified FOLFIRINOX (mFOLFIRINOX) and gemcitabine plus nab-paclitaxel (GnP) are two of the preferred chemotherapy treatments at this time. The U.S. Food and Drug Administration (FDA) has approved each of these treatments for patients with borderline resectable pancreatic cancer. This study will alternate these two neoadjuvant chemotherapy treatments (GnP and mFOLFIRINOX). The study doctors hope that alternating these treatments may improve the treatment response, improve tumor removal (also called resectability), and lower the risk of cancer coming back.
Interventions
Administered ion days 1, 8 and 15 of cycles 1 and 3 (28-day cycles).
Administered ion days 1 and 15 of cycles 2 and 4 (28-day cycles).
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a single site, single-arm, open-label prospective clinical trial of the alternating GnP and mFOLFIRINOX regimens in selected patients with borderline-resectable pancreatic ductal adenocarcinoma (BR-PDAC) who have not received previous systemic or radiation therapy forPDAC.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| One-year event-free survival (1y-EFS) | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who require dose modification | 1 year |
| Proportion of patients who undergo surgery | 1 year |
| Radiographic response (unconfirmed) after chemotherapy, per RECIST | 1 year |
| Surgical resection rate (R0, R1 and R2 resection) | 1 year |
| Proportion of patients who complete the study intervention | 1 year |
| Recurrence-free survival (RFS) in patients who undergo surgery | 1 year |
| EFS (Event Free Survival) and OS (Overall Survival) | 1 year |
| Trend of CA19-9 | 1 year |
| Pathologic response observed in the surgical specimen | 1 year |
Countries
United States
Contacts
Primary ContactCancer Research Nurse
Outcome results
None listed