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

Primary Purpose

Vertebral Metastasis

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Stereotactic Radiation Therapy

SRT with Vertebral Augmentation Procedure

About this trial

This is an interventional treatment trial for Vertebral Metastasis focused on measuring Vertebral Metastasis, pain control, VAP, SRT+VAP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Sites / Locations

James Graham Brown Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Treatment Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Reduction of Pain Estimate

To estimate the relative quantitative reduction of pain from baseline in patients in each arm.

Quality of Life Estimate

To estimate the quality of life using the Oswestry Disability Questionnaire

Feasibility Rate Estimation

To estimate the feasibility rate of the study procedure (the percentage of patients in overall and each arm that complete the treatment).

Toxicity Rate Estimation

To estimate the toxicities of the treatment

Vertebra Measurement

To measure the dimensions of the treated vertebra(e) at 1 year

Full Information

NCT ID

NCT01527292

First Posted

February 2, 2012

Last Updated

January 14, 2019

Sponsor

University of Louisville

Collaborators

James Graham Brown Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT01527292

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Terminated

Why Stopped

Unable to enroll

Study Start Date

February 2012 (Actual)

Primary Completion Date

May 2, 2015 (Actual)

Study Completion Date

September 2, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Louisville

Collaborators

James Graham Brown Cancer Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Eligible Vertebral Metastatic Lesion/s-> randomized-> SRT versus SRT+ VAP Stereotactic Radiation Therapy(SRT): 16 Gy X 1 Evaluation: prior to treatment; 1 month, 2-4 months, 5-6 months and 1 year post-treatment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vertebral Metastasis

Keywords

Vertebral Metastasis, pain control, VAP, SRT+VAP

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Treatment Group

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Radiation Therapy

Other Intervention Name(s)

Stereotactic Radiosurgery

Intervention Description

SRT only

Intervention Type

Radiation

Intervention Name(s)

SRT with Vertebral Augmentation Procedure

Other Intervention Name(s)

Stereotactic Radiosurgery with VAP

Intervention Description

SRT with VAP

Primary Outcome Measure Information:

Title

Numerical Rating Pain Scale (NRPS) Change in Patients

Description

Time Frame

For 6 months post treatment

Secondary Outcome Measure Information:

Title

Reduction of Pain Estimate

Description

To estimate the relative quantitative reduction of pain from baseline in patients in each arm.

Time Frame

For 1 year post treatment

Title

Quality of Life Estimate

Description

To estimate the quality of life using the Oswestry Disability Questionnaire

Time Frame

For 1 year post treatment

Title

Feasibility Rate Estimation

Description

To estimate the feasibility rate of the study procedure (the percentage of patients in overall and each arm that complete the treatment).

Time Frame

For 1 year post treatment

Title

Toxicity Rate Estimation

Description

To estimate the toxicities of the treatment

Time Frame

For 1 year post treatment

Title

Vertebra Measurement

Description

To measure the dimensions of the treated vertebra(e) at 1 year

Time Frame

For 1 year post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shiao Y Woo, MD

Organizational Affiliation

James Graham Brown Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

James Graham Brown Cancer Center

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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