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

Gastrointestinal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784652
• Other study ID #: 4-2014-0440
• Status: Completed
• Phase: Phase 2
• First received: May 1, 2016
• Last updated: March 27, 2017
• Start date: June 2014
• Est. completion date: February 28, 2017

Study information

• Verified date: March 2017
• Source: Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastasis
• Bone Neoplasms
• Digestive System Neoplasms
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Neoplasm Metastasis

Intervention

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,

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief rate		Change from baseline pain extent at 1,3,6 months
Secondary	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
Secondary	Overall survival		at 18months after the IRB approval