Stereotactic Radiosurgery (SRS) for Spine Metastases

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-03-31

Brief Summary

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This study will evaluate the most effective radiation dose. Patients will be randomized (like flipping a coin) to receive either low dose stereotactic radiotherapy (defined as "14 Gy") or high dose stereotactic radiotherapy (defined as 18 Gy).

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Detailed Description

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This study will evaluate the pain control and the quality of life of patients with spinal metastases using stereotactic radiotherapy. Stereotactic radiotherapy is referred to as "targeted therapy". It uses special equipment to position the patient and guide the focused beams of radiation toward the cancer and away from normal surrounding tissue. This higher dose technique may work better to kill cancer cells with fewer side effects than standard radiation therapy.

Conditions

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Spinal Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy

Group Type ACTIVE_COMPARATOR

Stereotactic Radiosurgery

Intervention Type RADIATION

2

High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy

Group Type ACTIVE_COMPARATOR

Stereotactic Radiosurgery

Intervention Type RADIATION

Interventions

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Stereotactic Radiosurgery

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent.
* Age greater than or equal to 18 years old.
* Prior histologically-proven, non-hematogenous malignancy (Specific exclusions are multiple myeloma and lymphoma).
* Radiographic evidence of one or two non-contiguous spinal metastases amenable to SRS.
* Metastatic disease must be symptomatic (causing either pain or neurologic symptoms).
* Maximum tumor size less than or equal to 5 cm.
* Zubrod performance status of less than or equal to 3.
* Life expectancy of greater than or equal to 3 months.
* Women/Men of childbearing potential must use effective contraception.

Exclusion Criteria

* No prior radiation delivered to the involved area
* No evidence of spinal instability requiring urgent surgical intervention.
* No evidence of spinal cord compression requiring emergent surgical or radiotherapeutic intervention.
* No plans for concomitant antineoplastic therapy (including standard fractionated RT, chemotherapy, biologic, vaccine therapy, or surgery) while on this protocol except at disease progression.Concomitant is defined as within 3 days before or after radiosurgery.
* No pregnant or lactating women.
* No active systemic infection.
* No evidence of myelopathy or cauda equina syndrome on clinical evaluation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No