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

University of Erlangen-Nürnberg Medical School

Status and phase: Unknown; Phase 2

Conditions: Spinal Metastases

Treatments: Radiation: hypofractionated 12x3 Gy + integrated boost 12x4 Gy; Radiation: hypofractionated 10x3 Gy

Study type: Interventional

Funder types: Other

Identifiers

NCT01849510

SPIME2013

Details and patient eligibility

About

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.

Enrollment: 155 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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155 participants in 2 patient groups

dose intensified

Experimental group

Description:

hypofractionated 12x3 Gy + integrated boost 12x4 Gy

Treatment:

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

standard

Active Comparator group

Description:

hypofractionated 10x3 Gy

Treatment:

Radiation: hypofractionated 10x3 Gy