Vertebral Augmentation and Radiotherapy of Collapse Spinal Metastatic Cancer

NCT ID: NCT02376933

Last Updated: 2018-11-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-20

Study Completion Date

2017-04-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Cancers Multiple Myeloma Vertebral Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vertebroplasty with Radiotherapy

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

Group Type EXPERIMENTAL

Vertebroplasty

Intervention Type PROCEDURE

Under imaging guidance, a fractured vertebral body is stabilized with injected bone cement.

Radiotherapy

Intervention Type RADIATION

Radiotherapy of metastatic lesions to the spine.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vertebroplasty

Under imaging guidance, a fractured vertebral body is stabilized with injected bone cement.

Intervention Type PROCEDURE

Radiotherapy

Radiotherapy of metastatic lesions to the spine.

Intervention Type RADIATION

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

kyphoplasty

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Arizona

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Krisha Howell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona Radiation Oncology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Arizona

Tucson, Arizona, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1300000562

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.