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

Vertebral Metastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01527292
• Other study ID #: BCC-RAD-11-01
• Status: Terminated
• Phase: N/A
• Start date: February 2012
• Est. completion date: September 2, 2015

Study information

• Verified date: January 2016
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: September 2, 2015
• Est. primary completion date: May 2, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years.

2. ECOG performance status 0-1.

3. Known histologically proven malignancy.

4. 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).

5. Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.

6. Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control.

7. Numerical Rating Pain Scale (NRPS) and movement-related pain score(MRPS) within two (2) weeks prior to registration.

8. The patient must have a score of = 5 for at least one of the planned sites for SRT.

9. Patients must provide study specific informed consent prior to study entry.

10. 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:

1. Non-ambulatory patients.

2. Frank spinal cord compression or epidural compression within 3 mm of the spinal cord.

3. Osteoblastic vertebral metastasis.

4. Prior radiation to the index spine.

5. Patients with rapid neurologic decline.

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Neoplasms, Second Primary
• Vertebral Metastasis

Intervention

Radiation:
• Stereotactic Radiation Therapy
SRT only
• SRT with Vertebral Augmentation Procedure
SRT with VAP

Locations

Country	Name	City	State
United States	James Graham Brown Cancer Center	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	James Graham Brown Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reduction of Pain Estimate	To estimate the relative quantitative reduction of pain from baseline in patients in each arm.	For 1 year post treatment
Secondary	Quality of Life Estimate	To estimate the quality of life using the Oswestry Disability Questionnaire	For 1 year post treatment
Secondary	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).	For 1 year post treatment
Secondary	Toxicity Rate Estimation	To estimate the toxicities of the treatment	For 1 year post treatment
Secondary	Vertebra Measurement	To measure the dimensions of the treated vertebra(e) at 1 year	For 1 year post treatment