Vertebral Augmentation and Radiotherapy of Collapse Spinal Metastatic Cancer

NCT02376933 | Terminated Results DMC

• 1 other identifier: 1300000562
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Cancers; Multiple Myeloma; Vertebral Fracture

Keywords

vertebral bodies; vertebral fracture; vertebral augmentation; radiotherapy; vertebroplasty; kyphoplasty

Outcome Measures

Primary Outcomes (1)

• Pain Assessment From the Worst Pain Score on Brief Pain Inventory as Compared to Historical Radiation Therapy Oncology Group (RTOG) 9714 Study.

  Assessment of the patient's pain, activities and quality of life will be gathered from the patient in returning for follow-up or by contacting the patient by phone approximately 1 week following the completion of their first procedure, whether it be the vertebral augmentation or the radiotherapy (5 - 10 days following). Mandatory assessments include: \- Worst Pain Score - Brief Pain Inventory (BPI) - The Worst Pain Assessment on the Brief Inventory Scale is an assessment tool of current pain intensity and pain intensity within the last 24 hours when not on pain control medications. 0 being no pain and 10 is the worst pain possible. See protocol attachments

  14 weeks

Secondary Outcomes (3)

• Activity Level Assessment From the Roland Morris Questionnaire (RDQ) and Karnofsky Performance Status (KPS)

  14 weeks

• Quality of Life Assessment From the EORTC QLQ C30 Questionnaire.

  14 weeks

• Fracture Rates Detected From X-rays.

  14 weeks

Study Arms (1)

Vertebroplasty with Radiotherapy

EXPERIMENTAL

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

Procedure: Vertebroplasty; Radiation: Radiotherapy

Interventions

Vertebroplasty PROCEDURE

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

Also known as: kyphoplasty

Vertebroplasty with Radiotherapy

Radiotherapy RADIATION

Radiotherapy of metastatic lesions to the spine.

Vertebroplasty with Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Spinal Cord Compression

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Neoplasms; Multiple Myeloma; Spinal Fractures

Interventions

Vertebroplasty; Kyphoplasty; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Cementoplasty; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Results Point of Contact

• Title: Program Coordinator
• Organization: University of Arizona Cancer Center

aselegue@email.arizona.edu

520-626-0301

Study Officials

• Krisha Howell, MD

  University of Arizona Radiation Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2015
• First Posted: March 3, 2015
• Study Start: August 20, 2013
• Primary Completion: August 10, 2016
• Study Completion: April 7, 2017
• Last Updated: November 7, 2018
• Results First Posted: November 7, 2018

Record last verified: 2018-11

Locations

US (1)