NCT02622841

Brief Summary

The aim of this study is to assess the feasibility and safety of combining stereotactic body radiotherapy (SBRT) and pedicle screw fixation in a 48-hour window for the treatment of painful unstable metastases of the thoracic and/or lumbar spine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 7, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

1.8 years

First QC Date

September 17, 2015

Last Update Submit

May 5, 2017

Conditions

Neoplasm Metastasis

Keywords

First in manSpinal metastasesStereotactic bodyradiotherapyPalliative careSafetySurgical stabilisation

Outcome Measures

Primary Outcomes (1)

  • Occurrence of adverse events

    Occurrence of adverse events grade 3/4 according to the common terminology criteria for adverse events (CTCAE) 4.0

    first 90 days post treatment

Secondary Outcomes (8)

  • Pain response

    first 90 days post treatment

  • Duration of pain relief

    first 90 days post treatment

  • Rapidity of pain relief

    first 90 days post treatment

  • Hospital stay

    first 90 days post treatment

  • Early mortality

    First 30 days post treatment

  • +3 more secondary outcomes

Study Arms (1)

BLEND

EXPERIMENTAL

Combination of stereotactic bodyradiotherapy and surgical stabilization within 48 hours for the treatment of unstable spinal metastases.

Procedure: BLEND

Interventions

BLENDPROCEDURE

Stereotactic bodyradiotherapy and surgical stabilization within 48 hours.

BLEND

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Painful metastases from solid tumors in the thoracic or lumbar spine needing surgical stabilization
  • Histologic proof of malignancy
  • Radiographic evidence of spinal metastases
  • Karnofsky performance status ≤ 50
  • Written informed consent

You may not qualify if:

  • Multiple spinal metastases necessitating bridging more than five vertebral levels during surgery
  • Previous surgery or radiotherapy to index lesion
  • stereotactic body radiotherapy cannot be delivered (Bilsky score 2 and 3)
  • Neurological deficits (ASIA C, B or A)
  • Partial neurological deficits (ASIA D) with rapid progression (hours to days)
  • Inability to lie flat on table for stereotactic body radiotherapy
  • Non-ambulatory patients
  • Patient in hospice or with \< 3 months life expectancy
  • Medically inoperable or patient refused surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jorrit-Jan Verlaan, MD, PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 17, 2015

First Posted

December 7, 2015

Study Start

June 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

May 8, 2017

Record last verified: 2017-05

Locations

NL(1)