Clinical trial · Interventional
Neoadjuvant FIRINOX for Borderline Resectable Pancreatic Cancer - a Pilot Study
The Pilot Study of Neoadjuvant Chemotherapy of FIRINOX for Patients With Borderline Resectable Pancreatic Cancer
- 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)
FOLFIRINOX regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. FOLFIRINOX is one of the high response rate treatment regimen , the investigators considered as a promising treatment as neoadjuvant chemotherapy . On the other hand , incidences of grade 3 or 4 neutropenia , febrile neutropenia and diarrhea were significantly higher in the FOLFIRINOX group compared with gemcitabine group. Therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from FOLFIRINOX regimen
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 |
|---|---|---|---|
| Patients With Borderline Resectable Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FIRINOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Optimal chemotherapy courses
- description
- Neoadjuvant chemotherapy 4 courses of FIRINOX early 5 patients, and 8 courses of FIRINOX subsequent 5 patients
- interventionNames
- Drug: FIRINOX
Primary outcomes (1)
- measure
- Number of participants with toxicity of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.
- timeFrame
- Up to 30 weeks.
- description
- Toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0.
Secondary outcomes (3)
- measure
- The resection rate of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically proven invasive pancreatic ductal carcinoma * Cases that meet the definition of borderline resectable pancreatic cancer 1) or 2) 1. Definition of a borderline resectable pancreatic cancer is filledin NCCN guideline version 1.2014 pancreatic adenocarcinoma 2. Patients indicated distal pancreatectomy with en bloc celiac axis resection * PS (ECOG) 0-1 * ≧20 years old and \< 75 years old * First line treatment * The following criteria must be satisfied in laboratory tests within 14 days of registration White blood cell count ≦12,000/mm3 Neutrophil count ≧1,500/mm3 Platelet count ≧100,000mm3 Total bilirubin \<2.0mg/dL Serum Creatinine ≦upper limits of normal(ULN) AST, ALT≦2.5×ULN Albumin≧3.0g/dL Hemoglobin≧9.0g/dL * Written informed consent to participate in this study Exclusion Criteria: * Severe drug hypersensitivity * Multiple primary cancers within 5 years * Severe infection * With grade2 or more severe peripheral neuropathy * With intestinal paralysys, ileus * Interstitial pneumonia or pulmonary * With uncontrollable pleural effusion or ascites * Receiving atazanavir sulfate * With uncontrollable diabetes * With uncontrollable heart failure, angina, hypertension, arrhythmia * With severe psychological symptoms * With watery diarrhea * Pregnant or lactating women, or women with known or suspected pregnancy * Inappropriate patients for entry on this study in the judgment of the investigator * With UGT1A1\*28 and/or UGT1A1\*6 polymorphisms
References
Publications (0)
Data not yet available