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Price Institute of Surgical Research
University of Louisville




Current Clinical Trials

Patients are invited to work with us so that together we may refine and improve medical and surgical treatments. Two full-time study coordinators Laura Trachtenberg, MS, and Anna Williford, RN, as well as Wendy Kaiser, RN, administer these studies.

Anna Williford, RN, with patient
Anna Williford, RN, and a patient discuss a research study.

Digestive Surgergy Research Laboratory | Surgical Oncology Laboratory
Surgical Infection Laboratory

Digestive Surgery Research Laboratory
Through the Digestive Surgery Research Laboratory, patients of University of Louisville's Section of Colon & Rectal Surgery have the opportunity to participate in research by enrolling in clinical trials. Below are trials that have been open to patient accrual over the last year, many of which are still ongoing. To learn more about our ongoing studies, please contact our research coordinator Anna Williford, RN, at (502) 583-0880.

"A randomized controlled trial to compare the functional outcome and quality of life of patients with low rectal cancer who undergo a J Pouch or a side to end coloanal anastomosis."
PI: Galandiuk, S.
(Sponsor: The Cleveland Clinic)

"Protocol C13007/ A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease."
PI: Galandiuk, S.
(Sponsor: Millennium Pharmaceutical, Inc.)

"Protocol C13008/ A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease."
PI: Galandiuk, S.
(Sponsor: Millennium Pharmaceutical, Inc.)

"A 5-Year, Non-Interventional Registry Study of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Crohn’s Disease (CD)."
PI: Galandiuk, S.
(Sponsor: Abbott Pharmaceutical, Inc.)

"Prospective open-label study of a smokeless tobacco product in Crohn's disease patients with moderately to severely active Crohn's disease who have failed prior attempts at smoking cessation."
PI and Sponsor: Galandiuk, S.

"The Association of Gastrointestinal Disease, DNA Repair and Host Defense Genes."
PI and Sponsor: Galandiuk, S.

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Surgical Oncology Laboratory
At the Surgical Oncology Research Laboratory, the following clinical trials are being conducted:

"Randomized Comparative Study of FOLFOX6m Plus Sir-Spheres® Microspheres versus FOLFOX6m Alone as First Line Treatment in Patients with Non-Resectable Liver metastases from Primary Colorectal Carcinoma."
PI: Martin, R.
(Sponsor: Sirtex Technology Ltd.)

"A Phase II Study of Neoadjuvant Therapy with Cisplatin, Docetaxel, Panitumumab Plus Radiation Therapy Followed by Surgery in Patients with Locally Advanced Adenocarcinoma of the Distal Esophagus."
PI: Martin, R.
(Sponsor: ACOSOG Z4051)

"A Phase II Study of Preoperative Gemcitabine and Erlotinib Plus Pancreatectomy and Postoperative Gemcitabine and Erlotinib for Patients with Operable Pancreatic Adenocarcinoma."
PI: Martin, R.
(Sponsor: ACOSOG Z5041)

"A Phase III Randomized, Double-Blind, Placebo-Controlled Study of Sorafenib as Adjuvant Treatment for Hepatocellular Carcinoma after Surgical Resection or Local Ablation."
PI: Martin, R.
(Sponsor: Bayer Healthcare Pharmaceuticals)

"Global Investigation of Therapeutic Decision in Hepatocellular Carcinoma and of its Treatment: An International Non-Interventional Study with Nexavar® to Evaluate the Safety in Patients with Unresectable Heaptocellular Carcinoma Who are being Treated with Nexavar."
PI: Martin, R.
(Sponsor: Bayer Healthcare Pharmaceuticals)

"Drug-Eluting Bead, Irinotecan (DEBIRI) Therapy of Liver Metastasis from Colon Cancer with Concomitant Systemic Oxaliplatin, Fluorouracil and Leucovorin Chemotherapy, and Anti-Angiogenic Therapy."
PI: Martin, R.
(Sponsor: University of Louisville/Biocompatibles UK Ltd.)

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Surgical Infection Laboratory
The following study is being conducted at the Surgical Infection Laboratory:

"SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection."
PI: Polk HC, Jr.
(Sponsor: SIS)

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