CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
High-precision RT 5x5 Gy in 1 weekradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03070431
NCT03070431N/ACompleted

High-precision Radiotherapy of Motor Deficits Due to Metastatic Spinal Cord Compression

University Hospital Schleswig-Holstein·interventional·Posted Mar 3, 2017·Updated Mar 3, 2020

In Brief

A clinical study evaluating High-precision RT 5x5 Gy in 1 week for Spinal Cord Compression Due to Metastasis to Spine. Completed, enrolled 44 participants across 1 site.

Detailed Summary

The major goal of this clinical study is to investigate to which extent high-precision radiotherapy (RT) with modern techniques can prevent progression or recurrence of motor deficits (weakness) of the legs following RT. In addition, it will be evaluated to which extent RT can lead to improvement of motor function, ambulatory status, sensory function and sphincter dysfunction, to pain relief and to improvement in quality of life, side effects and overall survival. For this purpose 44 patients who will receive modern high-precision RT treatment for the metastases on their vertebral bodies will be included into this phase 2 study. The results of the high-precision RT with a treatment of 5x5 Gray (Gy) in 1 week will be compared to data of a historical control group. The data set of the historical control group consists of more than 500 patients who received conventional RT with 5x4 Gy. The data collected in 1 week treatment will be compared. It is intended to show superiority regarding the local progression-free survival (LPFS) for the high-precision RT when compared with the conventional RT.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 3, 2017
Enrollment StartJan 15, 2017
Primary CompletionFeb 28, 2019
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.3 years ago

Interventions

High-precision RT 5x5 Gy in 1 weekradiation

Patients included in this study will receive a high-precision radiotherapy with 5x5 Gy in 1 week