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Efficacy of Dose Intensified Radiotherapy of Spinal Metastases by Hypofractionated Radiation and IGRT hfSRT Mediated Boost (SPIN-MET)

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ClinicalTrials.gov Identifier: NCT01849510
Recruitment Status : Unknown
Verified August 2017 by University of Erlangen-Nürnberg Medical School.
Recruitment status was:  Recruiting
First Posted : May 8, 2013
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Brief Summary:
Spinal metastases indicate for an incurable course of disease. Local tumor control after palliative radiotherapy of spinal metastases (10x3 Gy, 1x8Gy) is between 61 to 81%. In 30% of patients, therapy fails locally within two years associated with further symptoms that are difficult to treat, because a further radiation of already radiated vertebra leads to a higher rate of myelitis. This trial aims to improve local tumor control and control of pain by radiotherapy with increase in total and single dose. Dose elevation is realized by simultaneous, integrated boost mediated by image-guided stereotactic radiotherapy (IGRT & hfSRT) and by elevation of elective dose in vertebral body with 12x3 Gy (standard: 10x3 Gy). Primary endpoint is local tumor control (time up to progression). Secondary endpoints are pain control associated with quality of live, severity of acute and chronic adverse effects and overall survival. It is planned to recruit a total number of 155 patients.

Condition or disease Intervention/treatment Phase
Spinal Metastases Radiation: hypofractionated 12x3 Gy + integrated boost 12x4 Gy Radiation: hypofractionated 10x3 Gy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Dose Intensified Radiotherapy of Spinal Metastases of Solid Tumors by Dose Increased, Homogeneous Radiation of Vertebral Body and Simultaneous Application of Stereotactic Boost.
Study Start Date : March 2013
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Experimental: dose intensified
hypofractionated 12x3 Gy + integrated boost 12x4 Gy
Radiation: hypofractionated 12x3 Gy + integrated boost 12x4 Gy
hypofractionated, homogeneous radiation (12x3 Gy) with simultaneously administrated, integrated boost (12x4 Gy) mediated by IGRT & hfSRT

Active Comparator: standard
hypofractionated 10x3 Gy
Radiation: hypofractionated 10x3 Gy
hypofractionated, homogeneous radiation (10x3 Gy)




Primary Outcome Measures :
  1. tumor control (time up to progression) [ Time Frame: up to progression (MR-imaging), max. 5 years after therapy ]

Secondary Outcome Measures :
  1. severity of acute and chronic adverse effects [ Time Frame: acute: assessment up to 6 weeks after therapy; chronic: assessment up to 60 months after therapy or up to progression ]
  2. overall survival [ Time Frame: assessment 60 months after therapy or up to death ]
  3. pain control [ Time Frame: assessment 60 months after therapy ]
    by visual analog scala and questionnaires according pain



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • minimum age 18
  • expectance of life at least 6 months
  • Karnofsky-Score > 50
  • 1-3 vertebral body metastases
  • Up to 5 other, macroscopic metastases
  • effective contraception
  • geographic reachability of patients
  • Signed study-specific consent form prior to therapy
  • no on-treatment participation on other trials

Exclusion Criteria:

  • initial required neurosurgical decompression
  • rapid, neurological deterioration
  • prior radiotherapy of region for planned radiation
  • conditions that preclude the application of magnetic resonance tomography
  • malignancy: multiple myeloma or lymphoma
  • technical conditions preclude stereotactic irradiation (technical limitations of device)
  • pregnant or nursing women
  • Fertile patients who refuse effective contraception during study treatment
  • persistent drug and/or alcohol abuse
  • patients that are not able or willing to behave according to study protocol
  • absent attendance for personal, disease related data storage and transfer
  • on-treatment participation on other trials

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): NCT01849510


Contacts
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Contact: Sabine Semrau, MD ++49(0)9131 85 ext 33968 sabine.semrau@uk-erlangen.de
Contact: Rainer Fietkau, MD ++49(0)9131 85 ext 33968 st-studiensekretariat@uk-erlangen.de

Locations
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Germany
Universitätsklinikum Erlangen Recruiting
Erlangen, Germany, 91054
Contact: Sabine Semrau, MD    ++49(0) 9131 85 ext 33968    sabine.semrau@uk-erlangen.de   
Contact: Rainer Fietkau, MD    ++49(0) 9131 85 ext 33968    st-studiensekretariat@uk-erlangen.de   
Principal Investigator: Sabine Semrau, MD         
Sub-Investigator: Rainer Fietkau, MD         
Universitätsklinikum Frankfurt; Strahlentherapie Recruiting
Frankfurt/M., Germany, 60590
Universitätsklinikum Regensburg, Strahlentherapie Recruiting
Regensburg, Germany, 93053
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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Principal Investigator: Sabine Semrau, MD Strahlenklinik, Universitätsklinikum Erlangen

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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01849510     History of Changes
Other Study ID Numbers: SPIME2013
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017

Keywords provided by University of Erlangen-Nürnberg Medical School:
spinal metastases
vertebral body
stereotaxis
image-guided radiotherapy
hypofractionated
dose intensified
dose elevation

Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Neoplastic Processes
Neoplasms
Pathologic Processes