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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01527292

Enrollment

Registered

2012-02-07

Start date

2012-02-29

Completion date

2015-09-02

Last updated

2019-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vertebral Metastasis

Keywords

Vertebral Metastasis, pain control, VAP, SRT+VAP

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

Interventions

RADIATIONStereotactic Radiation Therapy

SRT only

RADIATIONSRT with Vertebral Augmentation Procedure

SRT with VAP

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Numerical Rating Pain Scale (NRPS) Change in Patients	For 6 months post treatment	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

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

Countries

United States

Participant flow

Participants by arm

Arm	Count
Control Group Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only Stereotactic Radiation Therapy: SRT only	0
Treatment Group Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure SRT with Vertebral Augmentation Procedure: SRT with VAP	3
Total	3

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Physician Decision	0	3

Baseline characteristics

Characteristic	Control Group	Treatment Group	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	3 Participants	3 Participants
Age, Continuous	—	61 years	61 years
Region of Enrollment United States	—	3 participants	3 participants
Sex: Female, Male Female	—	3 Participants	3 Participants
Sex: Female, Male Male	—	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 0	0 / 3
other Total, other adverse events	0 / 0	0 / 3
serious Total, serious adverse events	0 / 0	0 / 3

Outcome results

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

Time frame: For 6 months post treatment