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

Study Overview
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Brief Summary
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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.

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

Conditions
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Bone Metastasis, Gastrointestinal Cancer

Intervention / Treatment
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* Drug: Zoledronic acid
* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RT & Zoledronic acid<br>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 | Drug: Zoledronic acid<br>* Zoledronic acid: every 4 weeks, 6 times, 4.0 mg iv<br>* Other names: Zometa;Radiation: Radiotherapy<br>* Radiotherapy: 5 days/ week, 3 Gy * 10-13 fractions or 4 Gy * 5 fractions,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief rate |  | Change from baseline pain extent at 1,3,6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skeletal related events (fracture and spinal cord compression) | 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.) | at 18months after the IRB approval | 
| Overall survival |  | at 18months after the IRB approval |