Phase II Study of Oxaliplatin, Continuous 5-Fluorouracil and External Beam Radiation Followed by Gemcitabine in Patients With Locally Advanced Pancreatic Cancer
I. Determine the 1-year survival rate in patients with locally advanced, unresectable
adenocarcinoma of the pancreas treated with concurrent external beam radiotherapy,
oxaliplatin, and fluorouracil followed by gemcitabine.
I. Determine overall survival, time to disease progression, and confirmed response rate in
patients treated with this regimen.
II. Determine toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients undergo radiotherapy once daily, 5 days a week, for 5.5 weeks. Beginning
concurrently with radiotherapy, patients receive oxaliplatin IV over 2 hours on days 1, 15,
and 29 and fluorouracil IV continuously for 5.5 weeks. Beginning 4-6 weeks after the
completion of chemoradiotherapy, patients receive gemcitabine IV over 30 minutes on days 1
and 8. Treatment with gemcitabine repeats every 21 days for 4 courses in the absence of
disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
1-year survival rate
1-year survival will be considered "success". The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. If more than 1 patients is lost to follow-up, we will use Kaplan-Meier estimates for the 6-month and 12-month overall survival rates. 95% confidence intervals for the true success proportion will be calculated according the approach of Duffy and Santner.
At 1 year
North Central Cancer Treatment Group
United States: Food and Drug Administration
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