Clinical trial NCT02332408: CyberKnife Based Hypofractionated Radiotherapy for Vertebral Hemangiomas
Official title: CyberKnife Based Hypofractionated Radiotherapy Versus Conventional Linac Based Radiotherapy for Painful Vertebral Hemangiomas - Controlled Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hemangioma of Vertebral Column
Keywords: vertebral hemangioma
conventional radiotherapy
Cyber Knife radiotherapy
randomized trial
radioablation
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 80
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: Inclusion Criteria:

1. Confirmed vertebral hemangioma ,
2. Lesion visible in CT and MR
3. Pain located in area of the lesion
4. Informed consent for participation in the study and for radiotherapy in interested area

Exclusion Criteria:

1. Any previous radiotherapy in region of treated hemangioma
2. Spinal damage or disease that may be associated with an increased radiosensitivity
3. 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
4. Neurological deficits caused by the presence of hemangioma (patients should be considered for surgery)
5. Contradictions for MRI
6. Lack of informed consent.

Primary outcomes:
measure: Analgetic effect
timeFrame: 2 years
Secondary outcomes:
measure: Identification of radiologic prognostic and predictal factors of response to external beam radiotherapy (radiosurgery compared to conventional)
timeFrame: 2 years
measure: Identification of biochemical and physical prognostic factors of response to external beam radiotherapy (radiosurgery compared to conventional)
timeFrame: 2 years
Other outcomes:
Locations:
city: Gliwice
country: Poland
facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch
state: Wybrzeze AK 15
Study officials:
affiliation: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland
name: Leszek Miszczyk, MD, PhD
role: STUDY_DIRECTOR
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