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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Spinal Metastases
• Intervention / Treatment: Radiation: hypofractionated 12x3 Gy + integrated boost 12x4 Gy; Radiation: hypofractionated 10x3 Gy

• Study Type: Interventional
• Enrollment (Anticipated): 155
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany, 91054
    • Recruiting
    • Universitätsklinikum Erlangen
    • Contact: Rainer Fietkau, MD; Phone Number: 33968 ++49(0) 9131 85; Email: st-studiensekretariat@uk-erlangen.de
    • Sub-Investigator: Rainer Fietkau, MD
    • Contact: Sabine Semrau, MD; Phone Number: 33968 ++49(0) 9131 85; Email: sabine.semrau@uk-erlangen.de
    • Principal Investigator: Sabine Semrau, MD
  • Frankfurt/M., Germany, 60590
    • Recruiting
    • Universitätsklinikum Frankfurt; Strahlentherapie
  • Regensburg, Germany, 93053
    • Recruiting
    • Universitätsklinikum Regensburg, Strahlentherapie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
tumor control (time up to progression)	up to progression (MR-imaging), max. 5 years after therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	by visual analog scala and questionnaires according pain	assessment 60 months after therapy

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Investigators: Principal Investigator: Sabine Semrau, MD, Strahlenklinik, Universitätsklinikum Erlangen

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: April 18, 2013
• First Submitted That Met QC Criteria: May 3, 2013
• First Posted (Estimate): May 8, 2013

Study Record Updates

• Last Update Posted (Actual): August 11, 2017
• Last Update Submitted That Met QC Criteria: August 9, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: hypofractionated; spinal metastases; vertebral body; stereotaxis; image-guided radiotherapy; dose intensified; dose elevation
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: SPIME2013