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Intensity-modulated Radiotherapy With Integrated-boost in Patients With Spinal Bone Metastases

NCT02832765 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-07-14

No results posted yet for this study

Summary

The primary goal of the study is to determine the local control-rate after radiotherapy (RT) with and without simultaneous integrated boost (SIB) concepts in patients with bone metastases of the spine. Further study objectives are survival, and clinical parameters such as pain, quality of life (QoL) and fatigue. We expect an improvement in local control and consecutively an increased re-sclerotization of the bone metastasis due to a higher biological dose in the tumor area. Therefore patients could benefit in quality-of-life, pain relief and mobility.

Conditions

  • Vertebral Bony Metastases

Interventions

RADIATION

A

Intensity modulated radiotherapy (IMRT) 30Gy in 10 fractions of the involved spinal bone metastases

RADIATION

B

Intensity modulated radiotherapy (IMRT) 30Gy in 10 fractions with an SIB with 40 Gy in 10 fractions to the metastasis of the involved spinal bone metastases

RADIATION

C

Intensity modulated radiotherapy (IMRT) 20Gy in 5 fractions of the involved spinal bone metastases

RADIATION

D

Intensity modulated radiotherapy (IMRT) 20Gy in 5 fractions with an SIB with 30 Gy in 5 fractions to the metastasis of the involved spinal bone metastases

Sponsors & Collaborators

  • Heidelberg University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02832765 on ClinicalTrials.gov