Spinal Metastases
Conditions
Keywords
SRS
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.
Interventions
RADIATIONStereotactic Radiosurgery
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Control Rate as Measured by the The Brief Pain Inventory | 6 months after completion of treatment | 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. |
| Musculoskeletal Function as Measured by the Oswestry Disability Index | 6 months after completion of treatment | 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. |
| Quality of Life as Measured by the FACT-CNS Questionnaire | 6 months after completion of treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local Control Rate | 6 months after end of treatment | 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. |
Countries
United States
Participant flow
Recruitment details
The study opened to participant enrollment on 11/06/2007 and closed to participants enrollment on 03/26/2010.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Low Dose Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy | 1 |
| Arm 2: High Dose High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy | 1 |
| Total | 2 |
Baseline characteristics
| Characteristic | Arm 1: Low Dose | Arm 2: High Dose | 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 | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 1 participants | 1 participants | 2 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 1 | 1 / 1 |
| serious Total, serious adverse events | 1 / 1 | 0 / 1 |
Outcome results
Primary
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.
Time frame: 6 months after completion of treatment
Population: One patient experienced disease progression and was unable to continue to complete the required questionnaires. The second patient was removed from study due to non-compliance and did not complete the required questionnaires.
Primary
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.
Time frame: 6 months after completion of treatment
Population: One patient experienced disease progression and was unable to continue to complete the required questionnaires. The second patient was removed from study due to non-compliance and did not complete the required questionnaires.
Primary
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.
Time frame: 6 months after completion of treatment
Population: One patient experienced disease progression and was unable to continue to complete the required questionnaires. The second patient was removed from study due to non-compliance and did not complete the required questionnaires.
Secondary
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.
Time frame: 6 months after end of treatment
Population: The first patient progressed while on treatment and the second patient was removed from study due to non-compliance.