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Sponsors and Collaborators: |
University of Michigan Cancer Center Sanofi-Aventis Johns Hopkins University Princess Margaret Hospital, Canada Ohio State University |
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Information provided by: | University of Michigan Cancer Center |
ClinicalTrials.gov Identifier: | NCT00456599 |
This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer. This research treatment will evaluate the combination of two chemotherapy agents, oxaliplatin and gemcitabine with radiation therapy. The researchers have already done studies using oxaliplatin, gemcitabine and radiation therapy together for pancreatic cancer. They want to build on the information they have from this previous research and do the research at multiple sites.
They will use this study to determine how well people do who are treated with gemcitabine, oxaliplatin, and radiation therapy prior to having surgery for their pancreatic cancer. The researchers will also gather more information about what type of side effects occur with this treatment.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Drug: gemcitabine Drug: oxaliplatin Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment |
Official Title: | A Multi-Institutional Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer |
Estimated Enrollment: | 68 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | December 2013 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mark Zalupski, MD | 734-615-3969 | zalupski@umich.edu |
United States, Maryland | |
Johns Hopkins University | Recruiting |
Baltimore, Maryland, United States, 21231 | |
Contact: Joseph Herman, MD 410-502-3823 jherma15@jhmi.edu | |
Principal Investigator: Joseph Herman, MD | |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Principal Investigator: Mark Zalupski, MD | |
Sub-Investigator: Edgar Ben-Josef, MD | |
United States, Ohio | |
Ohio State University | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Tanios Bekaii-Saab, MD 614-293-9863 Tanios.Bekaii-Saab@osumc.edu | |
Principal Investigator: Tanios Bekaii-Saab, MD | |
Canada, Ontario | |
Princess Margaret Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Contact: Laura Dawson, MD 416-946-2125 laura.dawson@rmp.uhn.on.ca | |
Principal Investigator: Laura Dawson, MD |
Principal Investigator: | Mark Zalupski, MD | University of Michigan |
Responsible Party: | University of Michigan ( Mark Zalupski, MD ) |
Study ID Numbers: | UMCC 2006.025 |
Study First Received: | April 4, 2007 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00456599 History of Changes |
Health Authority: | United States: Institutional Review Board |
Antimetabolites Anti-Infective Agents Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Endocrine System Diseases Immunosuppressive Agents Antiviral Agents |
Oxaliplatin Digestive System Diseases Radiation-Sensitizing Agents Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Gemcitabine Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Digestive System Neoplasms Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Endocrine System Diseases Enzyme Inhibitors Immunosuppressive Agents |
Antiviral Agents Pharmacologic Actions Neoplasms Oxaliplatin Neoplasms by Site Digestive System Diseases Radiation-Sensitizing Agents Therapeutic Uses Pancreatic Diseases Gemcitabine Endocrine Gland Neoplasms |