drugset / Trial / NCT01032057

Gemcitabine, Capecitabine, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery

NCT01032057 ↗

Phase 2 Completed 114 enrolled Lisette Nixon
RandomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy that uses a 3-dimensional image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. It is not yet known which regimen of chemotherapy given together with radiation therapy is more effective in treating pancreatic cancer. PURPOSE: This randomized phase II trial is comparing the side effects of two regimens of gemcitabine and capecitabine given together with radiation therapy and to see how well they work in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.

Timeline

Start
2009-07
Primary completion
2013-01
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Capecitabine Small molecule 830 mg/m2 Oral
Comparator Gemcitabine Small molecule 300 mg/m2 Intravenous
Comparator Gemcitabine Small molecule 1000 mg/m2 Intravenous