CyberKnife Based Hypofractionated Radiotherapy for Vertebral Hemangiomas

NCT02332408 | Unknown Phase 3 DMC

• 1 other identifier: HRVH-COI-03
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Hemangioma of Vertebral Column

Keywords

vertebral hemangioma; conventional radiotherapy; Cyber Knife radiotherapy; randomized trial; radioablation

Outcome Measures

Primary Outcomes (1)

• Analgetic effect

  rate of pain relief

  2 years

Secondary Outcomes (2)

• 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

Study Arms (2)

Cybernetic microradiosurgery

EXPERIMENTAL

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

Conventional radiotherapy

ACTIVE COMPARATOR

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

Interventions

Cybernetic microradiosurgery RADIATION

Cybernetic microradiosurgery (6MV) using tracking to TD 25Gy given in five fraction (5Gy p fr) two or three days a week, during 2 weeks

Cybernetic microradiosurgery

Conventional radiotherapy RADIATION

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)

Conventional radiotherapy

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead

Study Sites (1)

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch

Gliwice, Wybrzeze AK 15, 44-100, Poland

RECRUITING

Related Publications (16)

• 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.

  PMID: 9490090 BACKGROUND

• 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.

  PMID: 14191260 BACKGROUND

• 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.

  PMID: 8905767 BACKGROUND

• 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.

  PMID: 19699592 BACKGROUND

• 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.

  PMID: 2261405 BACKGROUND

• 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.

  PMID: 10481773 BACKGROUND

• 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.

  PMID: 3972655 BACKGROUND

• Miszczyk L, Ficek K, Trela K, Spindel J. The efficacy of radiotherapy for vertebral hemangiomas. Neoplasma. 2001;48(1):82-4.

  PMID: 11327544 BACKGROUND

• 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.

  PMID: 2630926 BACKGROUND

• 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.

  PMID: 12504051 BACKGROUND

• 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.

  PMID: 1869466 BACKGROUND

• 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.

  PMID: 8992637 BACKGROUND

• 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.

  PMID: 2988274 BACKGROUND

• 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.

  PMID: 21640516 BACKGROUND

• 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.

  PMID: 15669812 BACKGROUND

• 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.

  PMID: 17994789 BACKGROUND

Study Officials

• Leszek Miszczyk, MD, PhD

  Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland

  STUDY DIRECTOR

Central Study Contacts

Leszek Miszczyk, MD, PhD

CONTACT

0048322788001; leszek@io.gliwice.pl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2015
• First Posted: January 6, 2015
• Study Start: September 1, 2014
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2021
• Last Updated: January 6, 2015

Record last verified: 2015-01

Locations

PL (1)