Vertebral Augmentation and Radiotherapy of Collapse Spinal Metastatic Cancer

University of Arizona

Status: Terminated

Conditions: Multiple Myeloma; Metastatic Cancers; Vertebral Fracture

Treatments: Procedure: Vertebroplasty; Radiation: Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02376933

1300000562

Details and patient eligibility

About

Vertebral augmentation with radiotherapy to increase the functional status and quality of life for patients with vertebral body metastatic cancers.

Full description

The study quantifies the reduction of pain and changes in quality of life associated with vertebral augmentation. This study is conducted in patients with metastatic cancer or multiple myeloma involving the spine. This study addresses the value of vertebral augmentation in combination with radiotherapy in the setting of cancer to the spine. The patient's pain, overall quality of life, and fracture development/avoidance will be compared to patients treated only with radiotherapy in the past.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of metastatic disease to the vertebra or multiple myeloma
• Negative pregnancy test within 2 weeks prior to registration
• Life expectancy of >= 3 months and Karnofsky performance status (KPS) score >= 40
• Pain scale score >=5
• Pain at involved vertebral body not adequately controlled
• Osteolysis of vertebral bodies
• Must agree to practice adequate means of birth control
• Must sign informed consent prior to study entry
• Must be able to understand the English language
• Absence of any serious cognitive or psychiatric problems potentially hampering compliance with the study and follow-up schedule.

Exclusion criteria

• Spinal Cord Compression

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Vertebroplasty with Radiotherapy

Experimental group

Description:

Vertebroplasty with Radiotherapy is given in either order. Radiotherapy dosage is at the discretion of the treating physician. Vertebroplasty is applied to fractured vertebrae.

Treatment:

Radiation: Radiotherapy

Procedure: Vertebroplasty