CyberKnife Based Hypofractionated Radiotherapy for Vertebral Hemangiomas (CKHRTVH)

Maria Sklodowska-Curie National Research Institute of Oncology

Status and phase: Unknown; Phase 3

Conditions: Hemangioma of Vertebral Column

Treatments: Radiation: Cybernetic microradiosurgery; Radiation: Conventional radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02332408

HRVH-COI-03

Details and patient eligibility

About

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

Full 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).

Enrollment: 80 estimated patients

Sex: All

Ages: 25 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Cybernetic microradiosurgery

Experimental group

Description:

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,

Treatment:

Radiation: Cybernetic microradiosurgery

Conventional radiotherapy

Active Comparator group

Description:

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,

Treatment:

Radiation: Conventional radiotherapy