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

Phase 2

• Conditions: Spinal Metastases
• Interventions: Radiation: hypofractionated 12x3 Gy + integrated boost 12x4 Gy; Radiation: hypofractionated 10x3 Gy

• Registration Number: NCT01849510
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-04-18
• Study First Submitted QC: 2013-05-03
• Study First Posted: 2013-05-08
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-09
• Last Update Posted: 2017-08-11
• Primary Completion: 2019-04
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 155

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dose intensified	hypofractionated 12x3 Gy + integrated boost 12x4 Gy	hypofractionated 12x3 Gy + integrated boost 12x4 Gy
standard	hypofractionated 10x3 Gy	hypofractionated 10x3 Gy

Primary Outcome Measures

Name	Time	Method
tumor control (time up to progression)	up to progression (MR-imaging), max. 5 years after therapy

Secondary Outcome Measures

Name	Time	Method
pain control	assessment 60 months after therapy	by visual analog scala and questionnaires according pain
severity of acute and chronic adverse effects	acute: assessment up to 6 weeks after therapy; chronic: assessment up to 60 months after therapy or up to progression
overall survival	assessment 60 months after therapy or up to death

Trial Locations

Locations (3)

Universitätsklinikum Frankfurt; Strahlentherapie; 🇩🇪 Frankfurt/M., Germany

Universitätsklinikum Regensburg, Strahlentherapie; 🇩🇪 Regensburg, Germany

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Germany