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

NCT ID: NCT02784652

Last Updated: 2017-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-02-28

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.

Conditions

Bone Metastasis; Gastrointestinal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RT & Zoledronic acid

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

Group Type: EXPERIMENTAL

Zoledronic acid

Intervention Type: DRUG

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

Radiotherapy

Intervention Type: RADIATION

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

Interventions

Zoledronic acid

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

Intervention Type: DRUG

Radiotherapy

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

Intervention Type: RADIATION

Other Intervention Names

Zolenic; Zometa

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jinsil Seong

Professor in Dept. of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Severance hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2014-0440

Identifier Type: -

Identifier Source: org_study_id

NCT02231476

Identifier Type: -

Identifier Source: nct_alias