Stereotactic Radiosurgery (SRS) for Spine Metastases

Study Overview
=================
Brief Summary
-----------------
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).

Detailed 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.

Official Title
-----------------
Stereotactic Radiosurgery (SRS) for One or Two Localized Spine Metastases

Conditions
-----------------
Spinal Metastases

Intervention / Treatment
-----------------
* Radiation: Stereotactic Radiosurgery


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy | Radiation: Stereotactic Radiosurgery<br> <br> |
| Active Comparator: 2<br>High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy | Radiation: Stereotactic Radiosurgery<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Control Rate as Measured by the The Brief Pain Inventory | The Brief Pain Inventory (BPI) is a 17 item patient self-rating scale assessing demographic data, use of medications, as well as sensory, and reactive components of pain. | 6 months after completion of treatment | 
| Musculoskeletal Function as Measured by the Oswestry Disability Index | The Oswestry Disability Index (ODI) has 10 sections (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling), each of which contains 6 questions detailing the effect of pain on the ability of the patient to perform activities related to the topic of each section. | 6 months after completion of treatment | 
| Quality of Life as Measured by the FACT-CNS Questionnaire | The Functional Assessment of Cancer Therapy - Central Nervous System (FACT-CNS). The FACT-CNS consists of Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, and Additional Concerns. Participants can choose 0 (Not At All) up to 4 (Very Much) for each question. | 6 months after completion of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Control Rate | Local control is lack of local failure. Local failure refers to the primary treated tumor after protocol therapy and corresponds to meeting both the following two criteria: 1) Increase in tumor dimension of 20% increase in the longest diameter of the target lesion tasking as reference the smallest longest diameter since the treatment started (referred to as local enlargement). 2) The measurable tumor with criteria meeting local enlargement should be avid on PET imaging (or bone scan) with uptake of a similar intensity as the pretreatment staging PET (or bone scan), or the measurable tumor should be biopsied confirming viable carcinoma. | 6 months after end of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SRS