CyberKnife Based Hypofractionated Radiotherapy for Vertebral Hemangiomas
NCT ID: NCT02332408
Last Updated: 2015-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
80 participants
INTERVENTIONAL
2014-09-30
2021-09-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cybernetic microradiosurgery
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,
Cybernetic microradiosurgery
Cybernetic microradiosurgery (6MV) using tracking to TD 25Gy given in five fraction (5Gy p fr) two or three days a week, during 2 weeks
Conventional radiotherapy
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,
Conventional radiotherapy
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)
Interventions
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Cybernetic microradiosurgery
Cybernetic microradiosurgery (6MV) using tracking to TD 25Gy given in five fraction (5Gy p fr) two or three days a week, during 2 weeks
Conventional radiotherapy
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)
Eligibility Criteria
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Inclusion Criteria
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
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.
25 Years
85 Years
ALL
No
Sponsors
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Maria Sklodowska-Curie National Research Institute of Oncology
OTHER
Responsible Party
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Principal Investigators
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Leszek Miszczyk, MD, PhD
Role: STUDY_DIRECTOR
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland
Locations
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Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch
Gliwice, Wybrzeze AK 15, Poland
Countries
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Central Contacts
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Facility Contacts
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References
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Sakata K, Hareyama M, Oouchi A, Sido M, Nagakura H, Tamakawa M, Akiba H, Morita K. Radiotherapy of vertebral hemangiomas. Acta Oncol. 1997;36(7):719-24. doi: 10.3109/02841869709001344.
BARTKOWIAK E, BEDNARCZYK J. [CAVERNOUS ANGIOMA OF THE SPINE COMPLICATED BY COMPRESSION VERTEBRAL FRACTURE]. Chir Narzadow Ruchu Ortop Pol. 1964;29:393-6. No abstract available. Polish.
Bremnes RM, Hauge HN, Sagsveen R. Radiotherapy in the treatment of symptomatic vertebral hemangiomas: technical case report. Neurosurgery. 1996 Nov;39(5):1054-8. doi: 10.1097/00006123-199611000-00039.
Heyd R, Seegenschmiedt MH, Rades D, Winkler C, Eich HT, Bruns F, Gosheger G, Willich N, Micke O; German Cooperative Group on Radiotherapy for Benign Diseases. Radiotherapy for symptomatic vertebral hemangiomas: results of a multicenter study and literature review. Int J Radiat Oncol Biol Phys. 2010 May 1;77(1):217-25. doi: 10.1016/j.ijrobp.2009.04.055. Epub 2009 Aug 21.
Asthana AK, Tandon SC, Pant GC, Srivastava A, Pradhan S. Radiation therapy for symptomatic vertebral haemangioma. Clin Oncol (R Coll Radiol). 1990 May;2(3):159-62. doi: 10.1016/s0936-6555(05)80151-7.
Brackrock S, Krull A, Schwarz R, Alberti W. [Results of radiotherapy for vertebral hemangioma]. Strahlenther Onkol. 1999 Aug;175(8):405-8. doi: 10.1007/s000660050029. German.
Faria SL, Schlupp WR, Chiminazzo H Jr. Radiotherapy in the treatment of vertebral hemangiomas. Int J Radiat Oncol Biol Phys. 1985 Feb;11(2):387-90. doi: 10.1016/0360-3016(85)90162-2.
Miszczyk L, Ficek K, Trela K, Spindel J. The efficacy of radiotherapy for vertebral hemangiomas. Neoplasma. 2001;48(1):82-4.
Pavlovitch JM, Nguyen JP, Djindjian M, Mazeron JJ, Piedbois P, Le Bourgeois JP. [Radiotherapy of vertebral hemangioma with neurologic complications]. Neurochirurgie. 1989;35(5):296-8, 305-8. French.
Rades D, Bajrovic A, Alberti W, Rudat V. Is there a dose-effect relationship for the treatment of symptomatic vertebral hemangioma? Int J Radiat Oncol Biol Phys. 2003 Jan 1;55(1):178-81. doi: 10.1016/s0360-3016(02)03734-3.
Schild SE, Buskirk SJ, Frick LM, Cupps RE. Radiotherapy for large symptomatic hemangiomas. Int J Radiat Oncol Biol Phys. 1991 Aug;21(3):729-35. doi: 10.1016/0360-3016(91)90693-x.
Winkler C, Dornfeld S, Baumann M, Christen N, Herrmann T, Eberhardt HJ. [The efficacy of radiotherapy in vertebral hemangiomas]. Strahlenther Onkol. 1996 Dec;172(12):681-4. German.
Yang ZY, Zhang LJ, Chen ZX, Hu HY. Hemangioma of the vertebral column. A report on twenty-three patients with special reference to functional recovery after radiation therapy. Acta Radiol Oncol. 1985 Mar-Apr;24(2):129-32. doi: 10.3109/02841868509134375.
Miszczyk L, Tukiendorf A. Radiotherapy of painful vertebral hemangiomas: the single center retrospective analysis of 137 cases. Int J Radiat Oncol Biol Phys. 2012 Feb 1;82(2):e173-80. doi: 10.1016/j.ijrobp.2011.04.028. Epub 2011 Jun 2.
Gerszten PC, Ozhasoglu C, Burton SA, Vogel WJ, Atkins BA, Kalnicki S, Welch WC. CyberKnife frameless single-fraction stereotactic radiosurgery for benign tumors of the spine. Neurosurg Focus. 2003 May 15;14(5):e16. doi: 10.3171/foc.2003.14.5.17.
Sahgal A, Chou D, Ames C, Ma L, Lamborn K, Huang K, Chuang C, Aiken A, Petti P, Weinstein P, Larson D. Image-guided robotic stereotactic body radiotherapy for benign spinal tumors: theUniversity of California San Francisco preliminary experience. Technol Cancer Res Treat. 2007 Dec;6(6):595-604. doi: 10.1177/153303460700600602.
Other Identifiers
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HRVH-COI-03
Identifier Type: -
Identifier Source: org_study_id
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