Clinical trial · Interventional
A Study of Neoadjuvant FOLFIRINOX and FDR-Gemcitabine With Concurrent IMRT in Patients
A Phase II Study of Neoadjuvant FOLFIRINOX and FDR-Gemcitabine With Concurrent IMRT in Patients With Borderline Resectable Pancreatic Cancer
NCT01661088CI-TRIAL-00041612completedPhase 2Results postedClinicalTrials.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 investigators hypothesize that the combination of the FOLFIRINOX regimen (a combination of 5-fluorouracil, irinotecan and oxaliplatin chemotherapy) to provide maximal systemic disease control and FDR-gemcitabine chemotherapy with concurrent IMRT (Radiation therapy) to address local disease, will achieve a significant improvement R0 resection (Radiation oncology repeat surgeries) rate in borderline resectable (surgical) pancreatic cancer and enhance disease free and overall survival in this patient population.
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 Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFIRINOX | Drug | — | UNRESOLVED |
| Intensity-modulated radiotherapy (IMRT) | Radiation | — | UNRESOLVED |
| Surgical Exploration | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study Treatment
- description
- Patients will receive FOLFIRINOX x 6 followed by IMRT concurrent with fixed dose rate (FDR)-gemcitabine (1g/m\^2) on days 1, 8, 22, 29. Intensity-modulated radiotherapy (IMRT): The prescribed dose was 50.0Gy in 2.0Gy per fraction. Patients without metastatic disease will be offered surgical exploration.
- interventionNames
- Drug: FOLFIRINOX
- Radiation: Intensity-modulated radiotherapy (IMRT)
- Procedure: Surgical Exploration
Primary outcomes (1)
- measure
- The Percentage of Patients That Underwent an R0 Resection
- timeFrame
- 6 months
- description
- To determine the frequency of achieving an R0 resection using a neoadjuvant regimen of FOLFIRINOX followed by IMRT concurrent with fixed dose rate (FDR)-gemcitabine in patients with borderline resectable pancreatic cancer. R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have cytologic or histologic confirmation of carcinoma arising in the pancreas. * Patients must be deemed to have borderline resectable disease with no radiologic evidence of distant metastatic disease prior to registration. * Specifically, patients must have at least one designation of borderline resectable and no designation of unresectable disease. * Patients must have a life expectancy of at least 12 weeks, a Zubrod performance status of \< 1 and be willing and medically able to undergo surgical resection. * Patients must have adequate organ function defined as follows: absolute neutrophil count of \> 1500/mm3, platelets \> 100,000/mm3, serum Cr \< 1.5 mg/dl, total bilirubin \< 2.0 mg/dl with relief of biliary obstruction if present (PTC tube or endobiliary stent). * Patients must be free of other active systemic malignancy, ongoing infection, or any other serious uncontrolled, concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy. * Patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial due to the unacceptable teratogenic toxicity of abdominal radiation and cytotoxic chemotherapy. * Patients must be aware of the investigational nature of the therapy and provide written informed consent. Exclusion Criteria: * Patients with neuroendocrine tumors are excluded. * Active systemic malignancy, ongoing infection, or any other serious uncontrolled, concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy. * Patients with preexisting peripheral neuropathy \> grade 2 are ineligible * Pregnant or nursing women are ineligible. * Patients must have no history of previous chemotherapy for pancreatic cancer or any abdominal radiation therapy. * Patients may not have used any investigational agent within 4 weeks prior to enrollment into the study.
References
Publications (1)
- DERIVEDTran NH, Sahai V, Griffith KA, Nathan H, Kaza R, Cuneo KC, Shi J, Kim E, Sonnenday CJ, Cho CS, Lawrence TS, Zalupski MM. Phase 2 Trial of Neoadjuvant FOLFIRINOX and Intensity Modulated Radiation Therapy Concurrent With Fixed-Dose Rate-Gemcitabine in Patients With Borderline Resectable Pancreatic Cancer. Int J Radiat Oncol Biol Phys. 2020 Jan 1;106(1):124-133. doi: 10.1016/j.ijrobp.2019.08.057. Epub 2019 Sep 5. PMID 31494181