Home
Search
Study Topics
Glossary
|
|
|
|
|
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date † | April 4, 2007 | ||||
Last Updated Date | July 28, 2008 | ||||
Start Date † | April 2007 | ||||
Current Primary Outcome Measures † |
Two-year disease free survival. | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00456599 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
|
||||
Original Secondary Outcome Measures † |
|
||||
Descriptive Information | |||||
Brief Title † | Study of Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer | ||||
Official Title † | A Multi-Institutional Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer | ||||
Brief Summary | 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. |
||||
Detailed Description | |||||
Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment | ||||
Condition † | Pancreatic Cancer | ||||
Intervention † |
|
||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Estimated Enrollment † | 68 | ||||
Estimated Completion Date | December 2013 | ||||
Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||
Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
|
||||
Location Countries † | United States, Canada | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00456599 | ||||
Responsible Party | Mark Zalupski, MD, University of Michigan | ||||
Secondary IDs †† | |||||
Study Sponsor † | University of Michigan Cancer Center | ||||
Collaborators †† |
|
||||
Investigators † |
|
||||
Information Provided By | University of Michigan Cancer Center | ||||
Verification Date | July 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |