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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02231476
Other study ID # Sev-4-2014-0440
Secondary ID
Status Recruiting
Phase Phase 2
First received August 26, 2014
Last updated May 27, 2015
Start date November 2014
Est. completion date January 2016

Study information

Verified date May 2015
Source Severance Hospital
Contact Jinsil Seong, MD, PhD
Phone 82-2228-8095
Email jsseong@yuhs.ac
Is FDA regulated No
Health authority Korea: Institutional Review Board
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, the 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 Recruiting
Enrollment 60
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
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

- Eastern Cooperative Oncology Group (ECOG): 0 ~ 2

- Pain: worst pain score on Brief Pain Inventory (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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Zoledronic acid
Radiotherapy: 5 days/ week, 3 Gy * 10-13 fractions or 4 Gy * 5 fractions Zoledronic acid: every 4 weeks, 6 times, 4.0 mg iv

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 from baseline at 6 months after RT Evaluation
at 1, 3, and 6 months after completion of RT, during administration of zoledronic acid (6 times, monthly)
Using Numeric rating scale (NRS) and Brief pain inventory (BPI)
Painkiller: convert into oral morphine equivalent dose (OMED)
6 months after RT No
Secondary skeletal related events (fracture and spinal cord compression) Evaluation: at 1, 3, and 6 months after completion of RT, during administration of zoledronic acid (6 times, monthly) 1 year 6 months Yes
Secondary Overall survival Analysis by Kaplan-Meier method 1 year 6 months Yes
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