NCT02784652

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

Phase II Study of Efficacy of Radiotherapy in Combination With Zoledronic Acid on Pain Relief in Bone Metastasis Patients With Gastrointestinal Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Severance Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bone Metastasis
• Gastrointestinal Cancer

Interventions

Type	Name	Description
DRUG	Zoledronic acid	Zoledronic acid: every 4 weeks, 6 times, 4.0 mg iv
RADIATION	Radiotherapy	Radiotherapy: 5 days/ week, 3 Gy \* 10-13 fractions or 4 Gy \* 5 fractions,

Timeline

• Start date: 2014-06-01
• Primary completion: 2017-02-28
• Completion: 2017-02-28
• First posted: 2016-05-27
• Last updated: 2017-03-29

Locations

1 site across 1 country: South Korea