Back to resultsEfficacy of Radiotherapy in Combination With Zoledronic Acid in Bone Metastasis Patients With Gastrointestinal Tumors
Primary Purpose
Bone Metastasis, Gastrointestinal Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Zoledronic acid
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Bone Metastasis
Eligibility Criteria
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
Sites / Locations
- Severance hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RT & Zoledronic acid
Arm Description
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
Outcomes
Primary Outcome Measures
Pain relief rate
Secondary Outcome Measures
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.)
Overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02784652
Brief Title
Efficacy of Radiotherapy in Combination With Zoledronic Acid in Bone Metastasis Patients With Gastrointestinal Tumors
Official Title
Phase II Study of Efficacy of Radiotherapy in Combination With Zoledronic Acid on Pain Relief in Bone Metastasis Patients With Gastrointestinal Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
February 28, 2017 (Actual)
Study Completion Date
February 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Severance Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Metastasis, Gastrointestinal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RT & Zoledronic acid
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Other Intervention Name(s)
Zolenic, Zometa
Intervention Description
Zoledronic acid: every 4 weeks, 6 times, 4.0 mg iv
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Radiotherapy: 5 days/ week, 3 Gy * 10-13 fractions or 4 Gy * 5 fractions,
Primary Outcome Measure Information:
Title
Pain relief rate
Time Frame
Change from baseline pain extent at 1,3,6 months
Secondary Outcome Measure Information:
Title
skeletal related events (fracture and spinal cord compression)
Description
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.)
Time Frame
at 18months after the IRB approval
Title
Overall survival
Time Frame
at 18months after the IRB approval
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Severance hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Radiotherapy in Combination With Zoledronic Acid in Bone Metastasis Patients With Gastrointestinal Tumors
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