A Phase I/II Dose Escalation Study Using Extracranial Stereotactic Radiosurgery to Control Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase I/II Dose Escalation Study to Evaluate Pain Response Using Extracranial Stereotactic Radiosurgery to Treat Paraspinal Metastasis in Patients Who Have Received Prior Spinal Irradiation

Conditions
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Metastases

Intervention / Treatment
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* Radiation: Stereotactic radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group -1<br>1000 cGY radiation | Radiation: Stereotactic radiotherapy<br>* 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.<br>* Other names: Prior Spinal Irradiation;|
| Experimental: Group 1<br>1200 cGY radiation | Radiation: Stereotactic radiotherapy<br>* 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.<br>* Other names: Prior Spinal Irradiation;|
| Experimental: Group 2<br>1400 cGY radiation | Radiation: Stereotactic radiotherapy<br>* 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.<br>* Other names: Prior Spinal Irradiation;|
| Experimental: Group 3<br>1600 cGY radiation | Radiation: Stereotactic radiotherapy<br>* 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.<br>* Other names: Prior Spinal Irradiation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal Dose of Stereotactic Spinal Irradiation Needed to Obtain Durable Pain Control at 4 Weeks in a Previously Irradiated Spine Field | Optimal dose the maximum tolerated dose (MTD) that will result in a 10% ESRT-induced neurological complications the minimal dose level that can achieve an 80% or more pain control rate, whichever occurs first | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 years | 
| 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 | 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. | 4 years |