Clinical Research Details

Descriptive Information
Neo-adjuvant FOLFIRINOX in borderline-respectable/locally advanced pancreatic adenocarcinoma

Sally Temraz



Farah Nassar
Extension: 5112
Conditions and Keywords
folfirinox ,borderline-resectable/locally advanced pancreatic adenocarcinoma
Evaluation of folfirinox in borderline-resectable/locally advanced pancreatic adenocarcinoma
Study Design
Basic / Translational
N/A: Not Applicable
N/A: Not Applicable
N/A: Not Applicable
Eligibility and IRB

Unresectable pancreatic adenocarcinoma remains a lethal disease with poor prognosis despite advances in systemic therapy. FOLFIRINOX chemotherapy has been shown to be superior to gemcitabine chemotherapy in a randomized phase III study in patients with advanced disease. Neo-adjuvant therapy with FOLFIRINOX in patients with locally advanced/borderline resectable disease has the potential to down-stage tumors enabling surgical resection. We aim to prospectively evaluate the effect neo-adjuvant FOLFIRINOX in patients with unresectable/borderline resectable pancreatic tumors at our institution.

  1. Histologically or cytologically confirmed locally advanced unresectable or borderline resectable adenocarcinoma of pancreas
  2. Patients must have measurable disease as defined by RECIST 1.1 RECIST evaluations must have occurred within 4 weeks prior to study entry
  3. No evidence of hepatic or pulmonary metastatic disease by CT
  4. Male or non-pregnant and non-lactating female age > or equal to 18 years and < or equal to 70 years of age
  5. Patient must have received no prior therapy for the treatment of locally advanced unresectable or borderline resectable pancreatic cancer
  6. Patients must have adequate blood counts at baseline and blood chemistry levels
  7. Patients must have ECOG Performance Status 0 to 1
  8. Patients must give signed informed consent for follow-up within the study

1.       Prior chemotherapy or radiation for pancreatic cancer

2.       History of allergy or hypersensitivity to the study drugs

3.       Metastatic disease on radiological staging

4.       Significant cardiac disease

5.       Peripheral sensory neuropathy > or equal to grade 2 at baseline