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

Primary Purpose

Spinal Metastases

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
hypofractionated 12x3 Gy + integrated boost 12x4 Gy
hypofractionated 10x3 Gy
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Metastases focused on measuring spinal metastases, vertebral body, stereotaxis, image-guided radiotherapy, hypofractionated, dose intensified, dose elevation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsklinikum ErlangenRecruiting
  • Universitätsklinikum Frankfurt; StrahlentherapieRecruiting
  • Universitätsklinikum Regensburg, StrahlentherapieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

dose intensified

standard

Arm Description

hypofractionated 12x3 Gy + integrated boost 12x4 Gy

hypofractionated 10x3 Gy

Outcomes

Primary Outcome Measures

tumor control (time up to progression)

Secondary Outcome Measures

severity of acute and chronic adverse effects
overall survival
pain control
by visual analog scala and questionnaires according pain

Full Information

First Posted
April 18, 2013
Last Updated
August 9, 2017
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT01849510
Brief Title
Efficacy of Dose Intensified Radiotherapy of Spinal Metastases by Hypofractionated Radiation and IGRT hfSRT Mediated Boost
Acronym
SPIN-MET
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 Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Metastases
Keywords
spinal metastases, vertebral body, stereotaxis, image-guided radiotherapy, hypofractionated, dose intensified, dose elevation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
155 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dose intensified
Arm Type
Experimental
Arm Description
hypofractionated 12x3 Gy + integrated boost 12x4 Gy
Arm Title
standard
Arm Type
Active Comparator
Arm Description
hypofractionated 10x3 Gy
Intervention Type
Radiation
Intervention Name(s)
hypofractionated 12x3 Gy + integrated boost 12x4 Gy
Intervention Description
hypofractionated, homogeneous radiation (12x3 Gy) with simultaneously administrated, integrated boost (12x4 Gy) mediated by IGRT & hfSRT
Intervention Type
Radiation
Intervention Name(s)
hypofractionated 10x3 Gy
Intervention Description
hypofractionated, homogeneous radiation (10x3 Gy)
Primary Outcome Measure Information:
Title
tumor control (time up to progression)
Time Frame
up to progression (MR-imaging), max. 5 years after therapy
Secondary Outcome Measure Information:
Title
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
Title
overall survival
Time Frame
assessment 60 months after therapy or up to death
Title
pain control
Description
by visual analog scala and questionnaires according pain
Time Frame
assessment 60 months after therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine Semrau, MD
Phone
++49(0)9131 85
Ext
33968
Email
sabine.semrau@uk-erlangen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Rainer Fietkau, MD
Phone
++49(0)9131 85
Ext
33968
Email
st-studiensekretariat@uk-erlangen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Semrau, MD
Organizational Affiliation
Strahlenklinik, Universitätsklinikum Erlangen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Semrau, MD
Phone
++49(0) 9131 85
Ext
33968
Email
sabine.semrau@uk-erlangen.de
First Name & Middle Initial & Last Name & Degree
Rainer Fietkau, MD
Phone
++49(0) 9131 85
Ext
33968
Email
st-studiensekretariat@uk-erlangen.de
First Name & Middle Initial & Last Name & Degree
Sabine Semrau, MD
First Name & Middle Initial & Last Name & Degree
Rainer Fietkau, MD
Facility Name
Universitätsklinikum Frankfurt; Strahlentherapie
City
Frankfurt/M.
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Regensburg, Strahlentherapie
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Efficacy of Dose Intensified Radiotherapy of Spinal Metastases by Hypofractionated Radiation and IGRT hfSRT Mediated Boost

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