Clinical trial · Interventional
Neoadjuvant Modified FOLFIRINOX in Borderline Resectable Pancreatic Cancer
Phase 2 Study of Neoadjuvant Modified FOLFIRINOX in Patients With Borderline Resectable Pancreas Adenocarcinoma
NCT02749136CI-TRIAL-00041890completedPhase 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 study is to assess the feasibility and efficacy outcomes of neoadjuvant modified FOLFIRINOX and postoperative gemcitabine in patients with 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 |
|---|---|---|---|
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Preoperative modified FOLFIRINOX and postoperative gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Perioperative chemotherapy
- description
- * Preoperative mFOLFIRINOX, every 2 weeks, 8 cycles * Postoperative gemcitabine, every 4 weeks, 3-6 cycles
- interventionNames
- Drug: Preoperative modified FOLFIRINOX and postoperative gemcitabine
Primary outcomes (1)
- measure
- 1-year progression-free survival (PFS) rate
- timeFrame
- 1 year
- description
- PFS rate at 1 year
Secondary outcomes (6)
- measure
- Progression-free survival (PFS)
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 19 years and older * Cytologically or histologically confirmed adenocarcinoma of the pancreas * Met the NCCN criteria for borderline resectable disease (assessed at Aug 23rd, 2015) * No previous chemotherapy or radiotherapy * Eastern Cooperative Oncology Group (ECOG) performance status 0 \~ 1 * Adequate bone marrow function as defined by platelets ≥ 100 x 109/L and neutrophils ≥ 1.5 x 109/L * Adequate renal function, with serum creatinine \< 1.5 x upper limit of normal (ULN) * Adequate hepatic function with serum total bilirubin \< 2 mg/dL, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 2.5 x ULN * No other malignant disease apart from non-melanotic skin cancer or carcinoma in situ of the uterine cervix or any other non life-threatening cancer (i.e., prostate or thyroid cancer) except where treated with curative intent \> 5 years previously without evidence of relapse * Written informed consent to the study Exclusion Criteria: * No potentially resectable disease or no metastatic disease * Locally advanced unresectable disease according to the NCCN criteria * Histologically confirmed adenosquamous carcinoma * Medical or psychiatric conditions that compromise the patient's ability to give informed consent or to complete the protocol or a history of non-compliance * Last dose of radiotherapy received within 4 weeks before the start of study treatment, excluding palliative radiotherapy * Obstruction of gastrointestinal tract * Active gastrointestinal bleeding * Myocardial infarction within 6 months prior to the study medication, and other clinically significant heart disease (e.g., unstable angina, congestive heart failure or uncontrolled hypertension) * Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardise compliance with the protocol * Female subjects who are pregnant or lactating, or males and females of reproductive potential not willing or not able to employ a highly effective method of birth control/contraception to prevent pregnancy from 2 weeks before receiving study drug until 3 months after receiving the last dose of study drug. A highly effective method of contraception is defined as having a low failure rate (\< 1% per year) when used consistently and correctly.
References
Publications (11)
- BACKGROUNDKatz MH, Marsh R, Herman JM, Shi Q, Collison E, Venook AP, Kindler HL, Alberts SR, Philip P, Lowy AM, Pisters PW, Posner MC, Berlin JD, Ahmad SA. Borderline resectable pancreatic cancer: need for standardization and methods for optimal clinical trial design. Ann Surg Oncol. 2013 Aug;20(8):2787-95. doi: 10.1245/s10434-013-2886-9. Epub 2013 Feb 23. PMID 23435609
- BACKGROUNDO'Reilly EM, Perelshteyn A, Jarnagin WR, Schattner M, Gerdes H, Capanu M, Tang LH, LaValle J, Winston C, DeMatteo RP, D'Angelica M, Kurtz RC, Abou-Alfa GK, Klimstra DS, Lowery MA, Brennan MF, Coit DG, Reidy DL, Kingham TP, Allen PJ. A single-arm, nonrandomized phase II trial of neoadjuvant gemcitabine and oxaliplatin in patients with resectable pancreas adenocarcinoma. Ann Surg. 2014 Jul;260(1):142-8. doi: 10.1097/SLA.0000000000000251. PMID 24901360
- BACKGROUNDHeinemann V, Haas M, Boeck S. Neoadjuvant treatment of borderline resectable and non-resectable pancreatic cancer. Ann Oncol. 2013 Oct;24(10):2484-2492. doi: 10.1093/annonc/mdt239. Epub 2013 Jul 12. PMID 23852311
- BACKGROUNDLee JL, Kim SC, Kim JH, Lee SS, Kim TW, Park DH, Seo DW, Lee SK, Kim MH, Kim JH, Park JH, Shin SH, Han DJ. Prospective efficacy and safety study of neoadjuvant gemcitabine with capecitabine combination chemotherapy for borderline-resectable or unresectable locally advanced pancreatic adenocarcinoma. Surgery. 2012 Nov;152(5):851-62. doi: 10.1016/j.surg.2012.03.010. Epub 2012 Jun 6. PMID 22682078
- BACKGROUNDHeestand GM, Murphy JD, Lowy AM. Approach to patients with pancreatic cancer without detectable metastases. J Clin Oncol. 2015 Jun 1;33(16):1770-8. doi: 10.1200/JCO.2014.59.7930. Epub 2015 Apr 27. PMID 25918279
- BACKGROUNDOettle H, Post S, Neuhaus P, Gellert K, Langrehr J, Ridwelski K, Schramm H, Fahlke J, Zuelke C, Burkart C, Gutberlet K, Kettner E, Schmalenberg H, Weigang-Koehler K, Bechstein WO, Niedergethmann M, Schmidt-Wolf I, Roll L, Doerken B, Riess H. Adjuvant chemotherapy with gemcitabine vs observation in patients undergoing curative-intent resection of pancreatic cancer: a randomized controlled trial. JAMA. 2007 Jan 17;297(3):267-77. doi: 10.1001/jama.297.3.267.