Hemangioma of Vertebral ColumnPhase 3CKHRTVHNCT02332408
CyberKnife Based Hypofractionated Radiotherapy for Vertebral Hemangiomas
A Phase 3 study testing Cybernetic microradiosurgery and Conventional radiotherapy in people with Hemangioma of Vertebral Column, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
Trial 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 Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Hemangioma of Vertebral Column
- What is being tested?
- Cybernetic microradiosurgery and Conventional radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2014to Sep 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch
Gliwice, Wybrzeze AK 15, 44-100
Leszek MIszczyk, MD. PhD, +48322788001, leszek@io.gliwice.pl
Leszek Miszczyk, MD, PhD
About this study
Official title: 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
Read the 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).
- Conditions
- Hemangioma of Vertebral Column
- Being tested
- Cybernetic microradiosurgery, Conventional radiotherapy
- Keywords
- vertebral hemangioma, conventional radiotherapy, Cyber Knife radiotherapy, randomized trial, radioablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cybernetic microradiosurgeryRadiation
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 radiotherapyRadiation
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)
| Study group | Role | What they receive |
|---|---|---|
| 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, Receives: 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, Receives: Radiation: Conventional radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgetic effect
rate of pain relief
Measured: 2 years
Secondary outcomes (2)
Identification of radiologic prognostic and predictal factors of response to external beam radiotherapy (radiosurgery compared to conventional)
Measured: 2 years
Identification of biochemical and physical prognostic factors of response to external beam radiotherapy (radiosurgery compared to conventional)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2019 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Hemangioma of Vertebral ColumnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leszek Miszczyk, MD, PhD, Study director, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332408
- Sponsor's protocol ID
- HRVH-COI-03
- Acronym
- CKHRTVH
- Status last verified
- Jan 2015
- First submitted
- 4 Jan 2015
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 9490090BARTKOWIAK 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.
PubMed 14191260Bremnes 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.
PubMed 8905767Heyd 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.
PubMed 19699592Asthana 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.
PubMed 2261405Brackrock 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.
PubMed 10481773Faria 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.
PubMed 3972655Miszczyk L, Ficek K, Trela K, Spindel J. The efficacy of radiotherapy for vertebral hemangiomas. Neoplasma. 2001;48(1):82-4.
PubMed 11327544Pavlovitch 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.
PubMed 2630926Rades 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.
PubMed 12504051Schild 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.
PubMed 1869466Winkler 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.
PubMed 8992637Yang 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.
PubMed 2988274Miszczyk 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.
PubMed 21640516Gerszten 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.
PubMed 15669812
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CyberKnife Based Hypofractionated Radiotherapy Versus Conventional Linac Based Radiotherapy for Painful Vertebral Hemangiomas - Controlled Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02332408
- Acronym / sponsor ID
- CKHRTVH / HRVH-COI-03
- Conditions
- Hemangioma of Vertebral Column
- Keywords
- vertebral hemangioma, conventional radiotherapy, Cyber Knife radiotherapy, randomized trial, radioablation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cybernetic microradiosurgery | Experimental | Radiation: Cybernetic microradiosurgeryHypofractionated 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, |
| Conventional radiotherapy | Active comparator | Radiation: Conventional radiotherapyConventionally 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, |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cybernetic microradiosurgeryCybernetic microradiosurgery (6MV) using tracking to TD 25Gy given in five fraction (5Gy p fr) two or three days a week, during 2 weeks | Radiation | Cybernetic microradiosurgery |
| Conventional radiotherapyConventionally 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) | Radiation | Conventional radiotherapy |
Primary outcome
Analgetic effect
Time frame: 2 years
rate of pain relief
2 secondary outcomes
Identification of radiologic prognostic and predictal factors of response to external beam radiotherapy (radiosurgery compared to conventional)
Time frame: 2 years
Identification of biochemical and physical prognostic factors of response to external beam radiotherapy (radiosurgery compared to conventional)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
- Background: PubMed 9490090Sakata 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.
- Background: PubMed 14191260BARTKOWIAK 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.
- Background: PubMed 8905767Bremnes 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.
- Background: PubMed 19699592Heyd 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.
- Background: PubMed 2261405Asthana 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.
- Background: PubMed 10481773Brackrock 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.
- Background: PubMed 3972655Faria 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.
- Background: PubMed 11327544Miszczyk L, Ficek K, Trela K, Spindel J. The efficacy of radiotherapy for vertebral hemangiomas. Neoplasma. 2001;48(1):82-4.
- Background: PubMed 2630926Pavlovitch 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.
- Background: PubMed 12504051Rades 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.
- Background: PubMed 1869466Schild 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.
- Background: PubMed 8992637Winkler 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leszek Miszczyk, MD, PhD study director
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cybernetic microradiosurgery and Conventional radiotherapy in people with Hemangioma of Vertebral Column, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leszek Miszczyk, MD, PhD (0048322788001, leszek@io.gliwice.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgetic effect (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02332408, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2015.