Phase 2
N=25
A Study of Neoadjuvant FOLFIRINOX and FDR-Gemcitabine With Concurrent IMRT in Patients
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01661088 ↗Enrolled (actual)
25
Serious AEs
24.0%
Results posted
Aug 2018
Primary outcome: Primary: The Percentage of Patients That Underwent an R0 Resection — 52 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- FOLFIRINOX (Drug); Intensity-modulated radiotherapy (IMRT) (Radiation); Surgical Exploration (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan Rogel Cancer Center
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Patients That Underwent an R0 Resection |
52 | — |
| SECONDARY Median Progression-free Survival Time |
13.1 | — |
| SECONDARY Median Overall Survival Time |
24.4 | — |
Summary
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.
Eligibility Criteria
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 1500/mm3, platelets > 100,000/mm3, serum Cr 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.
Data sourced from ClinicalTrials.gov (NCT01661088). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.