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Sponsors and Collaborators: |
University of Michigan Cancer Center Rush University Medical Center |
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Information provided by: | University of Michigan Cancer Center |
ClinicalTrials.gov Identifier: | NCT00593866 |
This is a research study for pancreatic cancer. One way of improving the results of current standard treatments is to try new approaches. This study will examine the use of a more advanced radiation therapy technique, called intensity modulated radiation therapy (IMRT), with chemotherapy. All subjects on this study will be treated with gemcitabine. This chemotherapy agent has been used for patients with pancreatic cancer. The researchers have already done studies using radiation therapy and gemcitabine. They want to build on the information they have from this previous research. The researchers want to find the best dose of IMRT that can be given at the same time that patients are receiving gemcitabine. To do this, they will vary the total dose of radiation received by patients on this study based on the information they have available from previously treated patients. The goal of the research is to identify the highest dose of IMRT that can be given at the same time as the chemotherapy without causing severe side effects.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Radiation: INTENSITY MODULATED RADIOTHERAPY Biological: Gemcitabine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | A Phase I/II Radiation Dose-Escalation Study of Intensity-Modulated Radiotherapy (IMRT) With Concurrent Gemcitabine in Patients With Unresectable Pancreatic Cancer |
Estimated Enrollment: | 50 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | May 2012 |
Estimated Primary Completion Date: | May 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: Monika R Benedict-Blue, BSW | 734-936-4596 | shabla@umich.edu |
United States, Illinois | |
Rush University Medical Center | Recruiting |
Chicago, Illinois, United States, 60612-3833 | |
Contact: Ross Abrams, MD 312-942-5771 Ross_A_Abrams@rush.edu | |
Contact: William Leslie, MD | |
Principal Investigator: Ross Abrams, MD | |
Sub-Investigator: William Leslie, MD | |
United States, Michigan | |
University Of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109-5010 | |
Contact: Edgar Ben-Josef, MD 734-936-8207 edgarb@umich.edu | |
Contact: Mark Zalupski, MD 734-615-3969 zalupski@umich.edu | |
Principal Investigator: Edgar Ben-Josef, MD | |
Sub-Investigator: Mark Zalupski, MD |
Principal Investigator: | Edgar Ben-Josef, MD | University of Michigan |
Responsible Party: | University of Michigan ( Edgar Ben-Josef, MD ) |
Study ID Numbers: | UMCC 2006.018, IRB #HUM3315 |
Study First Received: | January 2, 2008 |
Last Updated: | September 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00593866 History of Changes |
Health Authority: | United States: Institutional Review Board |
Patients who have confirmed cancer arising from the pancreas |
Antimetabolites Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Endocrine System Diseases Pancrelipase Antiviral Agents Immunosuppressive Agents |
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 Neoplasms by Site Digestive System Diseases Radiation-Sensitizing Agents Therapeutic Uses Pancreatic Diseases Gemcitabine Endocrine Gland Neoplasms |