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NCT Number: NCT02784652

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

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.

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Key information

Conditions

Bone Metastasis Digestive System Diseases Digestive System Neoplasms Gastrointestinal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Severance hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zoledronic acid

Drug

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

Other names: Zolenic, Zometa

Radiotherapy

Radiation

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

Primary outcomes

  1. Pain relief rate

    Time frame: Change from baseline pain extent at 1,3,6 months

Secondary outcomes

  1. skeletal related events (fracture and spinal cord compression)

    Time frame: at 18months after the IRB approval

    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.)

  2. Overall survival

    Time frame: at 18months after the IRB approval

Sponsors and collaborators

Lead sponsor

Severance Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 27, 2016
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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