NCT00456599

Study of Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer

A Multi-Institutional Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.

Detailed description

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine	Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1, 8, and 15 of a treatment cycle.
DRUG	oxaliplatin	Oxaliplatin 85mg/m2 will be infused following gemcitabine over approximately 90 minutes on days 1 and 15 of a treatment cycle.
PROCEDURE	Radiation	The total dose in a three week treatment block will be 30 Gy in 2.0 Gy fractions.

Timeline

• Start date: 2007-04-01
• Primary completion: 2012-05-01
• Completion: 2013-01-01
• First posted: 2007-04-05
• Last updated: 2015-12-03
• Results posted: 2014-04-15

Locations

4 sites across 2 countries: United States, Canada