Clinical trial · Interventional
24BRO681 : Alternating Gnp and mFOLFIRINOX for BR-PDAC
24BRO681 : Neoadjuvant Therapy With Alternating Gemcitabine Plus Nab-Paclitaxel and mFOLFIRINOX for Borderline Resectable Pancreatic Adenocarcinoma: A Phase 2 Clinical Trial
NCT07043270CI-TRIAL-00120861recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this research is to study the effects and safety of alternating neoadjuvant chemotherapy on borderline resectable pancreatic cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreas Adenocarcinoma | Pancreatic Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| modified FOLFIRINOX (mFOLFIRINOX) | Drug | — | UNRESOLVED |
| Nab-paclitaxel + Gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment with Gemcitabine plus Nab-Paclitaxel and mFOLFIRINOX
- description
- Patient has been diagnosed with borderline resectable pancreatic ductal adenocarcinoma (pancreatic cancer) and has not received systemic or radiation therapy. Treating physician has recommended neoadjuvant (pre-operative) chemotherapy and radiation, prior to surgery.
- interventionNames
- Drug: Nab-paclitaxel + Gemcitabine
- Drug: modified FOLFIRINOX (mFOLFIRINOX)
Primary outcomes (1)
- measure
- One-year event-free survival (1y-EFS)
- timeFrame
- I year
- description
- 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 outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.