Study of Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer
|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|
|Primary Completion Date :||May 2012|
|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.
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|