drugset / Trial / NCT01065870

Neoadjuvant GTX With Chemoradiation for Pancreatic Cancer (Stage II/III)

NCT01065870

Phase 2/3 Unknown 64 enrolled Columbia University
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study is for patients with locally advanced pancreatic cancer (cancer that involves the local blood vessels so it cannot be removed without cutting major blood vessels) that cannot be treated with surgery. The purpose of this study is to assess the safety and benefit of 6 three week cycles of chemotherapy treatment consisting of gemcitabine, capecitabine and docetaxel (also called 'GTX'). The patients fall into two groups. Group I are those with only venous involvement. Group II patients have arterial involvement and may also have venous involvement. If there is arterial involvement, GTX will be followed by 5 and 1/2 weeks of radiation therapy with gemcitabine and capecitabine. After the chemotherapy and radiation treatment, participants may be able to have surgery to remove any remaining pancreatic cancer.

Timeline

Start
2009-12
Primary completion
2014-12
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1500 mg/m2 Oral
Subject Docetaxel Small molecule 30 mg/m2 Intravenous
Subject Gemcitabine Small molecule 750 mg/m2 Intravenous

Indications