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

Spinal Metastases Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01849510
• Other study ID #: SPIME2013
• Status: Recruiting
• Phase: Phase 2
• First received: April 18, 2013
• Last updated: August 9, 2017
• Start date: March 2013
• Est. completion date: April 2019

Study information

• Verified date: August 2017
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Sabine Semrau, MD
• Phone: ++49(0)9131 85
• Email: sabine.semrau[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 155
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Neoplasms, Second Primary
• Spinal Metastases

Intervention

Radiation:
• hypofractionated 12x3 Gy + integrated boost 12x4 Gy
hypofractionated, homogeneous radiation (12x3 Gy) with simultaneously administrated, integrated boost (12x4 Gy) mediated by IGRT & hfSRT
• hypofractionated 10x3 Gy
hypofractionated, homogeneous radiation (10x3 Gy)

Locations

Country	Name	City	State
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	Universitätsklinikum Frankfurt; Strahlentherapie	Frankfurt/M.
Germany	Universitätsklinikum Regensburg, Strahlentherapie	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor control (time up to progression)		up to progression (MR-imaging), max. 5 years after therapy
Secondary	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
Secondary	overall survival		assessment 60 months after therapy or up to death
Secondary	pain control	by visual analog scala and questionnaires according pain	assessment 60 months after therapy