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

Yonsei University

Status and phase: Completed; Phase 2

Conditions: Gastrointestinal Cancer; Bone Metastasis

Treatments: Radiation: Radiotherapy; Drug: Zoledronic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02784652

4-2014-0440

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

RT & Zoledronic acid

Experimental group

Description:

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

Treatment:

Drug: Zoledronic acid

Radiation: Radiotherapy