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Clinical Trials :: A Randomized, Phase II/III, Study of TNFerade Biologic with 5-FU and Radiation Therapy for First-Line Treatment of Unresectable Locally Advanced Pancreatic Cancer



Ad Title: A Randomized, Phase II/III, Study of TNFerade Biologic with 5-FU and Radiation Therapy for First-Line Treatment of Unresectable Locally Advanced Pancreatic Cancer
Study Title: A Randomized, Phase II/III Study of TNFerade Biologic with 5-FU and Radiation Therapy for First-Line Treatment of Unresectable Locally Advanced Pancreatic Cancer
Protocol Number: 082007-088
Department(s) involved in the Study: Int Med - Hematology, Student Affairs
Purpose of the Study: To determine wheter TNFerade biologic, when administered concurrently with standard of care (5-FU/radiation therapy followed by gemcitabine or gemcitabine/erlotinib maintenance therapy) improves 12-month survival rate as compared to standard of care alone.
Participant Eligibility: Interested individuals must be 18 or older with unresectable, locally advanced adenocarcinoma of the pancreas proven by biopsy or cytology who have not received previous treatment for pancreatic cancer, have a Karnofsky Performance Status of 70% or greater, life expectancy greater than 3 months, measurable disease and sign informed consent. Must be compliant with all study requirements. Spanish speaking patients are eligible to participate.
Disease/Condition Under Study: Unresectable locally advanced adenocarcinoma of the pancreas
Cancer Related Study: Yes
Study Drug(s): Adrucil, Efudex, 5-Fluorouracil, TNFerade (AdGVEGR.TNF.11D)
Study Device(s):
Study Doctor: Dr. Yull Arriaga
Location of Study:
Sites Recruiting at this Site
Parkland Memorial Hospital Yes
UT Southwestern University Hospitals St. Paul Building Yes
UT Southwestern University Hospitals Zale Lipshy Building Yes
Aston Ambulatory Care Center Yes
UT Southwestern Moncrief Cancer Center, UT Southwestern Medical Center Yes
Contact Phone: 214-648-5107
Email: dendra.vonmerveldt@utsouthwestern.edu
Other Information:
Website Keywords: GI Cancer
Medical Keywords: Adenocarcinoma, Pancreas, Pancreatic Cancer