Study of Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00456599|
Recruitment Status : Completed
First Posted : April 5, 2007
Results First Posted : April 15, 2014
Last Update Posted : December 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: gemcitabine Drug: oxaliplatin Procedure: Radiation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Institutional Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||January 2013|
Experimental: Oxaliplatin & gemcitabine with radiation
This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.
Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1, 8, and 15 of a treatment cycle.
Other Name: GemzarDrug: oxaliplatin
Oxaliplatin 85mg/m2 will be infused following gemcitabine over approximately 90 minutes on days 1 and 15 of a treatment cycle.
Other Name: EloxatinProcedure: Radiation
The total dose in a three week treatment block will be 30 Gy in 2.0 Gy fractions.
Other Name: RT
- Two-year Disease Free Survival. [ Time Frame: two years ]The percent of patients alive and disease-free at two years.
- Time to Treatment Failure [ Time Frame: 2 years ]Median time for disease recurrence after surgery.
- Overall Survival [ Time Frame: 5 years ]Percent overall survival was calculated for all evaluable patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456599
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21231|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Ohio|
|Ohio State University|
|Columbus, Ohio, United States, 43210|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Mark Zalupski, MD||University of Michigan|