CyberKnife Based Hypofractionated Radiotherapy for Vertebral Hemangiomas (CKHRTVH)

January 4, 2015 updated by: Maria Sklodowska-Curie National Research Institute of Oncology

CyberKnife Based Hypofractionated Radiotherapy Versus Conventional Linac Based Radiotherapy for Painful Vertebral Hemangiomas - Controlled Randomized Clinical Trial.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Wybrzeze AK 15
      • Gliwice, Wybrzeze AK 15, Poland, 44-100
        • Recruiting
        • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgetic effect
Time Frame: 2 years
rate of pain relief
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Identification of radiologic prognostic and predictal factors of response to external beam radiotherapy (radiosurgery compared to conventional)
Time Frame: 2 years
2 years
Identification of biochemical and physical prognostic factors of response to external beam radiotherapy (radiosurgery compared to conventional)
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Investigators

  • Study Director: Leszek Miszczyk, MD, PhD, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

January 4, 2015

First Submitted That Met QC Criteria

January 4, 2015

First Posted (Estimate)

January 6, 2015

Study Record Updates

Last Update Posted (Estimate)

January 6, 2015

Last Update Submitted That Met QC Criteria

January 4, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRVH-COI-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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