NCT02784652

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 27, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

2.7 years

First QC Date

May 1, 2016

Last Update Submit

March 27, 2017

Conditions

Bone MetastasisGastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

  • Pain relief rate

    Change from baseline pain extent at 1,3,6 months

Secondary Outcomes (2)

  • skeletal related events (fracture and spinal cord compression)

    at 18months after the IRB approval

  • Overall survival

    at 18months after the IRB approval

Study Arms (1)

RT & Zoledronic acid

EXPERIMENTAL

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 acidRadiation: Radiotherapy

Interventions

Zoledronic acidDRUG

Zoledronic acid: every 4 weeks, 6 times, 4.0 mg iv

Also known as: Zolenic, Zometa
RT & Zoledronic acid
RadiotherapyRADIATION

Radiotherapy: 5 days/ week, 3 Gy \* 10-13 fractions or 4 Gy \* 5 fractions,

RT & Zoledronic acid

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Zoledronic AcidRadiotherapy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTherapeutics

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Dept. of Radiation Oncology

Study Record Dates

First Submitted

May 1, 2016

First Posted

May 27, 2016

Study Start

June 1, 2014

Primary Completion

February 28, 2017

Study Completion

February 28, 2017

Last Updated

March 29, 2017

Record last verified: 2017-03

Locations

KR(1)