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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2019-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Spinal Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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dose intensified

hypofractionated 12x3 Gy + integrated boost 12x4 Gy

Group Type EXPERIMENTAL

hypofractionated 12x3 Gy + integrated boost 12x4 Gy

Intervention Type RADIATION

hypofractionated, homogeneous radiation (12x3 Gy) with simultaneously administrated, integrated boost (12x4 Gy) mediated by IGRT \& hfSRT

standard

hypofractionated 10x3 Gy

Group Type ACTIVE_COMPARATOR

hypofractionated 10x3 Gy

Intervention Type RADIATION

hypofractionated, homogeneous radiation (10x3 Gy)

Interventions

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hypofractionated 12x3 Gy + integrated boost 12x4 Gy

hypofractionated, homogeneous radiation (12x3 Gy) with simultaneously administrated, integrated boost (12x4 Gy) mediated by IGRT \& hfSRT

Intervention Type RADIATION

hypofractionated 10x3 Gy

hypofractionated, homogeneous radiation (10x3 Gy)

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No