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Trial record 27 of 201 for:    hemangioma

CyberKnife Based Hypofractionated Radiotherapy for Vertebral Hemangiomas (CKHRTVH)

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ClinicalTrials.gov Identifier: NCT02332408
Recruitment Status : Recruiting
First Posted : January 6, 2015
Last Update Posted : January 6, 2015
Sponsor:
Information provided by (Responsible Party):
Maria Sklodowska-Curie Institute - Oncology Center

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

Condition or disease Intervention/treatment Phase
Hemangioma of Vertebral Column Radiation: Cybernetic microradiosurgery Radiation: Conventional radiotherapy Phase 3

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CyberKnife Based Hypofractionated Radiotherapy Versus Conventional Linac Based Radiotherapy for Painful Vertebral Hemangiomas - Controlled Randomized Clinical Trial.
Study Start Date : September 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2021

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Arm Intervention/treatment
Experimental: 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,
Radiation: 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
Active Comparator: 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,
Radiation: 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)



Primary Outcome Measures :
  1. Analgetic effect [ Time Frame: 2 years ]
    rate of pain relief


Secondary Outcome Measures :
  1. Identification of radiologic prognostic and predictal factors of response to external beam radiotherapy (radiosurgery compared to conventional) [ Time Frame: 2 years ]
  2. Identification of biochemical and physical prognostic factors of response to external beam radiotherapy (radiosurgery compared to conventional) [ Time Frame: 2 years ]


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Ages Eligible for Study:   25 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02332408


Contacts
Contact: Leszek Miszczyk, MD, PhD 0048322788001 leszek@io.gliwice.pl

Locations
Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch Recruiting
Gliwice, Wybrzeze AK 15, Poland, 44-100
Contact: Leszek MIszczyk, MD. PhD    +48322788001    leszek@io.gliwice.pl   
Principal Investigator: Leszek Miszczyk, MD, PhD         
Sub-Investigator: Grzegorz Wozniak, MD PhD         
Sub-Investigator: Aleksandra Napieralska, MD         
Sub-Investigator: Andrzej Tukiendorf, PhD         
Sub-Investigator: MIchał Gola, MD         
Sub-Investigator: Michał Kalemba, MD         
Sponsors and Collaborators
Maria Sklodowska-Curie Institute - Oncology Center
Investigators
Study Director: Leszek Miszczyk, MD, PhD Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland

Publications:

Responsible Party: Maria Sklodowska-Curie Institute - Oncology Center
ClinicalTrials.gov Identifier: NCT02332408     History of Changes
Other Study ID Numbers: HRVH-COI-03
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: January 6, 2015
Last Verified: January 2015

Keywords provided by Maria Sklodowska-Curie Institute - Oncology Center:
vertebral hemangioma
conventional radiotherapy
Cyber Knife radiotherapy
randomized trial
radioablation

Additional relevant MeSH terms:
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms