SPIN-MET: Efficacy of Dose Intensified Radiotherapy of Spinal Metastases by Hypofractionated Radiation and IGRT hfSRT Mediated Boost

Sponsor

University of Erlangen-Nürnberg Medical School (Other)

Overall Status

Unknown status

CT.gov ID

NCT01849510

Collaborator

(none)

155

Enrollment

Locations

Arms

Duration (Months)

51.7

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Metastases	Radiation: hypofractionated 12x3 Gy + integrated boost 12x4 Gy Radiation: hypofractionated 10x3 Gy	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

155 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Mar 1, 2013

Anticipated Primary Completion Date :

Apr 1, 2019

Anticipated Study Completion Date :

Apr 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dose intensified hypofractionated 12x3 Gy + integrated boost 12x4 Gy	Radiation: hypofractionated 12x3 Gy + integrated boost 12x4 Gy hypofractionated, homogeneous radiation (12x3 Gy) with simultaneously administrated, integrated boost (12x4 Gy) mediated by IGRT & hfSRT
Active Comparator: standard hypofractionated 10x3 Gy	Radiation: hypofractionated 10x3 Gy hypofractionated, homogeneous radiation (10x3 Gy)

Arm

Intervention/Treatment

Experimental: dose intensified

hypofractionated 12x3 Gy + integrated boost 12x4 Gy

Radiation: hypofractionated 12x3 Gy + integrated boost 12x4 Gy

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

Active Comparator: standard

hypofractionated 10x3 Gy

Radiation: hypofractionated 10x3 Gy

hypofractionated, homogeneous radiation (10x3 Gy)

Outcome Measures

Primary Outcome Measures

tumor control (time up to progression) [up to progression (MR-imaging), max. 5 years after therapy]

Secondary Outcome Measures

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]
pain control [assessment 60 months after therapy]
by visual analog scala and questionnaires according pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Universitätsklinikum Erlangen	Erlangen	Germany	91054
2	Universitätsklinikum Frankfurt; Strahlentherapie	Frankfurt/M.	Germany	60590
3	Universitätsklinikum Regensburg, Strahlentherapie	Regensburg	Germany	93053