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

Phase 2

Completed

• Conditions: Gastrointestinal Cancer; Bone Metastasis
• Interventions: Drug: Zoledronic acid; Radiation: Radiotherapy

• Registration Number: NCT02784652
• Lead Sponsor: Severance Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2016-05-01
• Study First Submitted QC: 2016-05-24
• Study First Posted: 2016-05-27
• Primary Completion: 2017-02-28
• Study Completion: 2017-02-28
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with radiologic detectable bone metastasis (spine or non-spine)
• Patients with clinical diagnosis of gastrointestinal cancer: esophagus, stomach, colorectum, anus, liver, pancreas, gallbladder, biliary tract, etc.
• Patients over 20 years of age of both genders
• ECOG: 0 ~ 2
• Pain: worst pain score on BPI ≥3

Exclusion Criteria

• Undetectable bone metastasis on radiologic study
• Patients who have previous surgery history at same site
• Patients who are considered surgery first: pathologic fracture, neurological or radiological evidence of spinal cord compression, impending pathologic fracture
• Patients who have hypersensitivity for zoledronic acid or other bisphosphonate
• Patients who have treatment history with zoledronic acid or other bisphosphonate
• Abnormal renal function or history of kidney transplantation
• Patients with metabolic bone disease
• Synchronous symptomatic brain metastasis
• Women who are pregnant, breast-feeding, or possible pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RT & Zoledronic acid	Radiotherapy	Radiotherapy: 5 days/ week, 3 Gy \* 10-13 fractions or 4 Gy \* 5 fractions, Zoleronic acid: every 4 weeks, 6 times, 4.0 mg iv
RT & Zoledronic acid	Zoledronic acid	Radiotherapy: 5 days/ week, 3 Gy \* 10-13 fractions or 4 Gy \* 5 fractions, Zoleronic acid: every 4 weeks, 6 times, 4.0 mg iv

Primary Outcome Measures

Name	Time	Method
Pain relief rate	Change from baseline pain extent at 1,3,6 months

Secondary Outcome Measures

Name	Time	Method
skeletal related events (fracture and spinal cord compression)	at 18months after the IRB approval	skeletal related events (SRE) (fracture, spinal cord compression due to metastasis requiring operation or radiotherapy. Occurence of pain is not regarded as SRE.) (SRE including fracture will be evaluated with plain X-ray at 1 month after completion of RT, and plain X-ray and MRI at 3 months after completion of RT.; all imaging studies will be reviwed by clinician and radiologist.)
Overall survival	at 18months after the IRB approval

Trial Locations

Locations (1)

Severance hospital; 🇰🇷 Seoul, Korea, Republic of