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

NCT01849510 | Unknown Phase 2 DMC

• 1 other identifier: SPIME2013
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 3

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.

Conditions

Spinal Metastases

Keywords

spinal metastases; vertebral body; stereotaxis; image-guided radiotherapy; hypofractionated; dose intensified; dose elevation

Outcome Measures

Primary Outcomes (1)

• tumor control (time up to progression)

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

Secondary Outcomes (3)

• 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

Study Arms (2)

dose intensified

EXPERIMENTAL

hypofractionated 12x3 Gy + integrated boost 12x4 Gy

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

standard

ACTIVE COMPARATOR

hypofractionated 10x3 Gy

Radiation: hypofractionated 10x3 Gy

Interventions

hypofractionated 12x3 Gy + integrated boost 12x4 Gy RADIATION

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

dose intensified

hypofractionated 10x3 Gy RADIATION

hypofractionated, homogeneous radiation (10x3 Gy)

standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• minimum age 18
• expectance of life at least 6 months
• Karnofsky-Score \> 50
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (3)

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

RECRUITING

Universitätsklinikum Frankfurt; Strahlentherapie

Frankfurt/M., 60590, Germany

RECRUITING

Universitätsklinikum Regensburg, Strahlentherapie

Regensburg, 93053, Germany

RECRUITING

Study Officials

• Sabine Semrau, MD

  Strahlenklinik, Universitätsklinikum Erlangen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabine Semrau, MD

CONTACT

++49(0)9131 85; sabine.semrau@uk-erlangen.de

Rainer Fietkau, MD

CONTACT

++49(0)9131 85; st-studiensekretariat@uk-erlangen.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: May 8, 2013
• Study Start: March 1, 2013
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: August 11, 2017

Record last verified: 2017-08

Locations

DE (3)