Efficacy of Radiotherapy in Combination With Zoledronic Acid on Pain Relief in Bone Metastasis Patients

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: Recruiting

Administrative data

• NCT number: NCT02231476
• Other study ID #: Sev-4-2014-0440
• 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

Related Conditions & MeSH terms

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

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