Radiation Therapy and Capecitabine/Oxaliplatin Chemotherapy in the Treatment of Locally Advanced Pancreas Adenocarcinoma

Completed · Phase 1

Conditions studied: Cancer, Pancreas

In brief

The study is a prospective phase I trial of radiation therapy concurrent with capecitabine and oxaliplatin chemotherapy in the treatment of locally advanced pancreas adenocarcinoma. Eligibility criteria include pathologically confirmed, non-metastatic adenocarcinoma of the pancreas that is surgically unresectable. Patients will undergo radiation therapy (28 treatments of 1.8 Gy for a total of 50.4 Gy) concurrent with capecitabine and oxaliplatin chemotherapy. The primary objective of the study is to determine the maximum tolerated doses of capecitabine and oxaliplatin when delivered concurrently with 50.4 Gy radiation therapy with or without surgery in this patient population. Secondary objectives of the study are to determine the tumor response rate, survival rate, local control rate and the rate of distant metastases following capecitabine, oxaliplatin, and radiation therapy with or without surgery and to determine the rate at which patients with unresectable disease become resectable.

Key facts

Study ID
NCT00707278
Run by
University of Utah
People needed
13
Starts
2005-09-01
Expected to finish
2011-08-01
Last updated by the study team
2014-10-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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