Metastases
Conditions
Brief summary
This study will evaluate pain control and quality of life in patients with paraspinal metastases, who have receive previous radiation therapy to these lesions, using single dose stereotactic radiotherapy.
Detailed description
The goal of the study is to determine the lowest dose of radiation that can be given to effectively control the tumor and provide effective pain relief.
Interventions
RADIATIONStereotactic radiotherapy
This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment patient's pain, and how many side effects participants before you have experienced.
Sponsors
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 * Prior non-hematogenous, histologically proven malignancy (specific exclusions are multiple myeloma and lymphoma) * Pain attributable to one or two radiographically apparent metastatic lesion(s) amenable to ESRT * Have had prior radiation to area of spine felt to be cause of patient's pain * Zubrod performance status of 0-3 * Life expectancy of ≥ 3 months * Signed informed consent prior to registration to study * Radiographic evidence of stable disease outside of the spinal column for at least 6 weeks prior to study entry, as evaluated by pre-study imaging.
Exclusion criteria
* Women who are pregnant or nursing * Either 'no evidence of other active cancerous disease' or 'other sites of known disease are locally controlled' * No radiographic evidence of spinal instability (e.g. spinal cord compression requiring immediate surgical intervention) * No initiation of chemotherapy within 15 days of trial entry. * No plans for concomitant antineoplastic therapy (including standard fractionated RT, chemotherapy, biologic, vaccine therapy, or surgery) for at least 15 days following stereotactic radiosurgery. * No active systemic infection. * No evidence of myelopathy or cauda equina syndrome on clinical evaluation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Optimal Dose of Stereotactic Spinal Irradiation Needed to Obtain Durable Pain Control at 4 Weeks in a Previously Irradiated Spine Field | 4 weeks | Optimal dose 1. the maximum tolerated dose (MTD) that will result in a 10% ESRT-induced neurological complications 2. the minimal dose level that can achieve an 80% or more pain control rate, whichever occurs first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Pain Control for Each Dose Level. | 4 years | A reduction in pain, referable to the site of the spine lesion, by \>=30% according to the Brief Pain Inventory (BPI), or a smaller decrease in pain accompanied by a reduction of pain medications. |
| Determine the Rate of Radiation-induced Myelopathy From Stereotactic Re-irradiation of the Spinal Metastases. | 4 weeks | — |
| Determine the Pattern of Failure After Stereotactic Irradiation of Spinal Metastases. | 4 years | — |
| Quality of Life | 4 years | As measured by the Functional Assessment of Cancer Therapy - Central Nervous System (FACT-CNS) Participant can chose on a scale of 0-4 with 0=not at all and 4=very much. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group -1 1000 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced. | 0 |
| Group 1 1200 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced. | 1 |
| Group 2 1400 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced. | 0 |
| Group 3 1600 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced. | 0 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Group 1 | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 participants | 0 participants |
| Age, Categorical >=65 years | 0 participants | 0 participants |
| Age, Categorical Between 18 and 65 years | 1 participants | 1 participants |
| Gender Female | 1 participants | 1 participants |
| Gender Male | 0 participants | 0 participants |
| Region of Enrollment United States | 1 participants | 1 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 1 / 1 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 1 / 1 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Optimal Dose of Stereotactic Spinal Irradiation Needed to Obtain Durable Pain Control at 4 Weeks in a Previously Irradiated Spine Field
Optimal dose 1. the maximum tolerated dose (MTD) that will result in a 10% ESRT-induced neurological complications 2. the minimal dose level that can achieve an 80% or more pain control rate, whichever occurs first
Time frame: 4 weeks
Population: Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.
Secondary
Determine the Pattern of Failure After Stereotactic Irradiation of Spinal Metastases.
Time frame: 4 years
Population: Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.
Secondary
Determine the Rate of Radiation-induced Myelopathy From Stereotactic Re-irradiation of the Spinal Metastases.
Time frame: 4 weeks
Population: Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.
Secondary
Duration of Pain Control for Each Dose Level.
A reduction in pain, referable to the site of the spine lesion, by \>=30% according to the Brief Pain Inventory (BPI), or a smaller decrease in pain accompanied by a reduction of pain medications.
Time frame: 4 years
Population: Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.
Secondary
Quality of Life
As measured by the Functional Assessment of Cancer Therapy - Central Nervous System (FACT-CNS) Participant can chose on a scale of 0-4 with 0=not at all and 4=very much.
Time frame: 4 years
Population: Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.