CyberKnife Based Hypofractionated Radiotherapy for Vertebral Hemangiomas

Study Overview
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Brief Summary
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Clinical objective of the study is to compare the analgesic effect, toxicity and pathologic effect in the tumors of two radiotherapy schedules used for patients suffering from painful vertebral haemangiomas

Detailed Description
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Hemangiomas are frequent vertebral lesions (12% of the whole human population) but only 1% displays any clinical symptoms . The most common symptom is local pain, usually non responding for non-steroid anti-inflammatory drugs. Radiation therapy usually does not result calcification or the tumor regression, but significantly reduces the pain intensity or eliminates it. Currently, the most common RT schedule is conventional radiotherapy using fraction dose (fd) of 2 Gy delivered to the total dose (TD) varying from36 Gy to 40 Gy. The results in pain reduction achieved after larger total doses are better that led us to use radioablative techniques. This procedure is associated with a probability of better analgesic effect and the good local effect (calcification and / or regression of laesion) with high safety of radiation delivery using tracking based cybernetic microradiosurgery (CyberKnife). The comparison of two modalities of radiation therapy (conventional [fd 2 Gy, TD 36 Gy] and hypofractionated [fd 5 Gy, TD 25 Gy]) used for treatment of painful vertebral hemangioma patients will be performed in the phase III randomized study. 80 patients will be enrolled in this study. All patients will be planned (RT) on the base of CT/MRI fusion. Patients will be controlled 1, 3, 6, 9, 12 months after treatment completion and, next every each 6 months. Pain relief, analgesics uptake, local effect (MRI and Technetium - 99m-labelled RBC(red blood cell) scintigraphy) and eventual toxicity will be checked during follow-up (FU).

Official Title
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CyberKnife Based Hypofractionated Radiotherapy Versus Conventional Linac Based Radiotherapy for Painful Vertebral Hemangiomas - Controlled Randomized Clinical Trial.

Conditions
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Hemangioma of Vertebral Column

Intervention / Treatment
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* Radiation: Cybernetic microradiosurgery
* Radiation: Conventional radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed vertebral hemangioma , Lesion visible in CT and MR Pain located in area of the lesion Informed consent for participation in the study and for radiotherapy in interested area Exclusion Criteria: Any previous radiotherapy in region of treated hemangioma Spinal damage or disease that may be associated with an increased radiosensitivity The coexistence of the vertebral morphological changes at the level of hemangioma causing pressure on the nerve roots and / or spinal cord causing pain located in that area Neurological deficits caused by the presence of hemangioma (patients should be considered for surgery) Contradictions for MRI Lack of informed consent.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 85 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cybernetic microradiosurgery<br>Hypofractionated microradiosurgery using Cyber Knife to the vertebral hemangioma to the total dose of 25 Gy in 5.0 Gy per fraction, 2 or 3 days a week over the period of 2 weeks, | Radiation: Cybernetic microradiosurgery<br>* Cybernetic microradiosurgery (6MV) using tracking to TD 25Gy given in five fraction (5Gy p fr) two or three days a week, during 2 weeks<br>|
| Active Comparator: Conventional radiotherapy<br>Conventionally fractionated external beam conformal radiotherapy to the vertebral hemangioma to the total dose of 36 Gy in 2.0 Gy per fraction, 5 days a week over the period of 3,5 weeks, | Radiation: Conventional radiotherapy<br>* Conventionally fractionated linac based external beam radiation therapy - EBRT, (conformal or dynamic) to the TD of 36 Gy, in 2.0 Gy per fraction 5 days a week over the period of 3.5 weeks)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgetic effect | rate of pain relief | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of radiologic prognostic and predictal factors of response to external beam radiotherapy (radiosurgery compared to conventional) |  | 2 years | 
| Identification of biochemical and physical prognostic factors of response to external beam radiotherapy (radiosurgery compared to conventional) |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vertebral hemangioma, conventional radiotherapy, Cyber Knife radiotherapy, randomized trial, radioablation