Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis

NCT01527292 | Terminated Results DMC

• 1 other identifier: BCC-RAD-11-01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine pain control rate (Percentage of patients in each arm that achieve pain control) at the treated site(s) at 1 month, 2-4 months and 5-6 months post-treatment.

Conditions

Vertebral Metastasis

Keywords

Vertebral Metastasis; pain control; VAP; SRT+VAP

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Pain Scale (NRPS) Change in Patients

  To determine pain control rate (Percentage of patients in each arm that achieve pain control) at the treated site(s)at 1 month, 2-4 months and 5-6 months post-treatment and to validate of the movement-related pain score

  For 6 months post treatment

Secondary Outcomes (5)

• Reduction of Pain Estimate

  For 1 year post treatment

• Quality of Life Estimate

  For 1 year post treatment

• Feasibility Rate Estimation

  For 1 year post treatment

• Toxicity Rate Estimation

  For 1 year post treatment

• Vertebra Measurement

  For 1 year post treatment

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only

Radiation: Stereotactic Radiation Therapy

Treatment Group

EXPERIMENTAL

SRT with Vertebral Augmentation Procedure Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure

Radiation: SRT with Vertebral Augmentation Procedure

Interventions

Stereotactic Radiation Therapy RADIATION

SRT only

Also known as: Stereotactic Radiosurgery

Control Group

SRT with Vertebral Augmentation Procedure RADIATION

SRT with VAP

Also known as: Stereotactic Radiosurgery with VAP

Treatment Group

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years.
• ECOG performance status 0-1.
• Known histologically proven malignancy.
• Localized osteolytic spine metastases from T7 to L5 demonstrated by MRI, CT, PET or bone scan: a solitary spine metastasis; two separate spine levels; or up to 3 separate sites (each site may have a maximal involvement of 2 contiguous vertebral bodies with or without a paraspinal mass of no more than 5 cm).
• Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
• Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control.
• Numerical Rating Pain Scale (NRPS) and movement-related pain score(MRPS) within two (2) weeks prior to registration.
• The patient must have a score of ≥ 5 for at least one of the planned sites for SRT.
• Patients must provide study specific informed consent prior to study entry.
• Required Pre-treatment Evaluations: baseline Numerical Rating Pain Scale (NRPS), movement-related pain score, dose and frequency of all pain medications; QOL Measure using the Oswestry Disability Questionnaire, and EuroQOL(EQ-5D).

You may not qualify if:

• Non-ambulatory patients.
• Frank spinal cord compression or epidural compression within 3 mm of the spinal cord.
• Osteoblastic vertebral metastasis.
• Prior radiation to the index spine.
• Patients with rapid neurologic decline.

Sponsors & Collaborators

• University of Louisville: lead
• James Graham Brown Cancer Center: collaborator

Study Sites (1)

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dr. Shiao Woo
• Organization: University of Louisville, James Graham Brown Cancer Center

sywoo001@exchange.louisville.edu

502-561-2700

Study Officials

• Shiao Y Woo, MD

  James Graham Brown Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair-Radiation Oncology

Study Record Dates

• First Submitted: February 2, 2012
• First Posted: February 7, 2012
• Study Start: February 1, 2012
• Primary Completion: May 2, 2015
• Study Completion: September 2, 2015
• Last Updated: February 5, 2019
• Results First Posted: February 5, 2019

Record last verified: 2016-01

Locations

US (1)