drugset / Trial / NCT02784652

Efficacy of Radiotherapy in Combination With Zoledronic Acid in Bone Metastasis Patients With Gastrointestinal Tumors

NCT02784652

Phase 2 Completed 60 enrolled Severance Hospital
NaSingle-groupOpen-labelTreatment

Summary

Bone metastasis causes bone destruction and skeletal related events (SRE) including compression fracture, hypercalcemia, and spinal cord compression. Therefore, palliative treatments for pain control and local control have become important and multidisciplinary multimodality approach is needed for treatment of bone metastasis. The efficacy of radiotherapy (RT) for bone metastasis is well known. And the results that bisphosphonate decreases SRE in patients with solid tumor and multiple myeloma reported. In previous retrospective reports, the combination of local RT and systemic bisphosphonate was more effective than RT alone. Therefore, Investigators designed a phase II study to evaluate the efficacy of RT in combination with zoledronic acid on pain relief and the safety of RT in bone metastasis patients with gastrointestinal tumors.

Timeline

Start
2014-06
Primary completion
2017-02-28
Completion
2017-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Zoledronic acid Other / unclassified 4 mg Intravenous