Clinical trial NCT01849510: Efficacy of Dose Intensified Radiotherapy of Spinal Metastases by Hypofractionated Radiation and IGRT hfSRT Mediated Boost
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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Spinal Metastases
Keywords: spinal metastases
vertebral body
stereotaxis
image-guided radiotherapy
hypofractionated
dose intensified
dose elevation
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2013-05-08
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: tumor control (time up to progression)
timeFrame: up to progression (MR-imaging), max. 5 years after therapy
Secondary outcomes:
measure: severity of acute and chronic adverse effects
timeFrame: acute: assessment up to 6 weeks after therapy; chronic: assessment up to 60 months after therapy or up to progression
measure: overall survival
timeFrame: assessment 60 months after therapy or up to death
measure: pain control
timeFrame: assessment 60 months after therapy
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Frankfurt/M.
country: Germany
facility: Universitätsklinikum Frankfurt; Strahlentherapie
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg, Strahlentherapie
Study officials:
affiliation: Strahlenklinik, Universitätsklinikum Erlangen
name: Sabine Semrau, MD
role: PRINCIPAL_INVESTIGATOR
References: