Status:
COMPLETED
Phase I Study of Stereotactic Body Radiation Therapy and FOLFIRINOX in the Neoadjuvant Therapy of Pancreatic Cancer
Lead Sponsor:
Emory University
Conditions:
Cancer of Pancreas
Cancer of the Pancreas
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine whether using FOLFIRINOX chemotherapy and Stereotactic Body Radiation Therapy (SBRT) prior to surgery in patients with pancreatic cancer is safe and well tole...
Detailed Description
The current standard of care for treating early stage pancreatic cancer involves surgery followed by chemotherapy and / or chemoradiotherapy using conventional fractionated external beam radiation the...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01446458
Start Date
November 1 2011
End Date
March 1 2015
Last Update
March 22 2016
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
2
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322