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

University of Erlangen-Nürnberg Medical School155 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

155

Conditions

Spinal Metastases

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Universitätsklinikum Erlangen

Erlangen, Germany

RECRUITING

Universitätsklinikum Frankfurt; Strahlentherapie

Frankfurt/M., Germany

RECRUITING

Universitätsklinikum Regensburg, Strahlentherapie

Regensburg, Germany

RECRUITING

Outcomes

Primary Outcomes

tumor control (time up to progression)

Time frame: up to progression (MR-imaging), max. 5 years after therapy

Secondary Outcomes

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

overall survival

Time frame: assessment 60 months after therapy or up to death

pain control

by visual analog scala and questionnaires according pain

Time frame: assessment 60 months after therapy

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

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts