Phase I Study of Stereotactic Body Radiation Therapy and FOLFIRINOX in the Neoadjuvant Therapy of Pancreatic Cancer
Cancer of Pancreas, Cancer of the Pancreas, Neoplasms, Pancreatic
About this trial
This is an interventional treatment trial for Cancer of Pancreas focused on measuring Cancer of Pancreas, Cancer of the Pancreas, Neoplasms, Pancreatic, Pancreas Cancer, Pancreas Neoplasms, Entry Term Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria: Patients eligible must have:
- Histologic or cytologic diagnosis of pancreatic adenocarcinoma.
- Radiographically resectable or borderline resectable disease as reviewed by an experienced surgical oncologist at Emory.
- Age 21 years or older.
- Not received prior chemotherapy or radiation for pancreatic cancer.
- ECOG performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Adequate bone marrow function: absolute neutrophil count > 1,500/cmm, platelet count > 100,000/cmm.
- Understanding and be informed of the investigational nature of this study and must give written informed consent prior to the receiving of treatment per this protocol.
Exclusion Criteria: Patients who are not eligible have
- Histologies including endocrine tumors or lymphoma of the pancreas.
- A tumor which is less than 3 mm from the duodenum as measured by either CT or MRI.
- History of central nervous system (CNS) metastases.
- Liver dysfunction, including total bilirubin > 1.5 mg/dL; aspartate transaminase (AST) and alanine amino transferase (ALT) > 5 times upper limit of the institutional normal.
- Creatinine ≥ 1.5 mg/dL.
- Albumin ≤ 2.5 g/dL.
- International Normalized Ratio (INR) ≥ 1.5 (in the absence of ongoing treatment with warfarin).
- Breast feeding.
- Serious active infection.
- Serious concurrent systemic disorders incompatible with participating in the study (at the discretion of the investigator).
- An active second primary malignancy (except in situ carcinoma of the cervix, or adequately treated basal cell carcinoma of the skin) within less than one year of enrollment into this study.
- Clinical evidence of distant metastatic disease.
Sites / Locations
- Emory University Hospital Midtown
- Emory University Winship Cancer Institute
Arms of the Study
Arm 1
Experimental
5-Fluorouracil, Oxaliplatin, Irinotecan
5-Fluorouracil, Oxaliplatin, Irinotecan are administered as a modified FOLFIRINOX regimen every 15 days. Subjects receive bi-weekly cycles of therapy on the 1st week, the 3rd week, the 5th week and finally the 7th week for a total of 4 cycles. Assessments include history and physical, laboratory tests on a weekly basis throughout the treatment period prior to and including week 8 assessment for stereotactic body radiotherapy (SBRT).