Stereotactic Radiosurgery (SRS) for Spine Metastases

The Washington University

Status: Terminated

Conditions: Spinal Metastases

Treatments: Radiation: Stereotactic Radiosurgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00593320

07-0658

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

1

Active Comparator group

Description:

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

Treatment:

Radiation: Stereotactic Radiosurgery

2

Active Comparator group

Description:

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

Treatment:

Radiation: Stereotactic Radiosurgery