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Due to low accrual
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy |
|
| 2 | Active Comparator | High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Radiosurgery | Radiation |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Bradley, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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The study opened to participant enrollment on 11/06/2007 and closed to participants enrollment on 03/26/2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Low Dose | Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy |
| FG001 | Arm 2: High Dose | High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Low Dose | Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy |
| BG001 | Arm 2: High Dose | High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | 6 months after completion of treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Low Dose | Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Bradley, M.D. | Washington University School of Medicine | 314-362-8502 | jbradley@radonc.wustl.edu |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| 6 months after end of treatment |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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. | The first patient progressed while on treatment and the second patient was removed from study due to non-compliance. | Posted | 6 months after end of treatment |
|
|
| 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. | 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. | Posted | 6 months after completion of treatment |
|
|
| 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. | 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. | Posted | 6 months after completion of treatment |
|
|
| 1 |
| 1 |
| 1 |
| 1 |
| EG001 | Arm 2: High Dose | High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy | 0 | 1 | 1 | 1 |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alkaline phosphatase | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |