Image-guided and Intensity-modulated Radiotherapy Versus External Beam Radiotherapy for Patients With Spine Metastases

Conditions

Vertebral Bony Metastases

Keywords

bony metastases, palliative radiotherapy

Brief summary

The aim of this explorative trial is to verify the comparability of a fractionated intensity modulated radiotherapy with a conventional radiotherapy related to quality of life on the one hand and to evaluate toxicity, re-calcification and stability of vertebral body as well as pain relief and local response for palliative patients with painful spinal bone metastases on the other hand. This is a single-center, prospective randomized controlled trial with parallel-group design to determine the quality of life after RT in patients with spinal bone metastases. Two different techniques were evaluated: intensity modulated radiotherapy (IMRT) and fractionated conventional external beam RT with 10×3 Gy each. Experimental intervention: IMRT 10 x 3 Gy Control intervention: 3D-RT 10 x 3 Gy

Detailed description

The aim of this explorative trial is to verify the comparability of a fractionated intensity modulated radiotherapy with a conventional radiotherapy related to quality of life on the one hand and to evaluate toxicity, re-calcification and stability of vertebral body as well as pain relief and local response for palliative patients with painful spinal bone metastases on the other hand. This is a single-center, prospective randomized controlled trial with parallel-group design to determine the quality of life after RT in patients with spinal bone metastases. Two different techniques were evaluated: intensity modulated radiotherapy (IMRT) and fractionated conventional external beam RT with 10×3 Gy each. Experimental intervention: IMRT 10 x 3 Gy Control intervention: 3D-RT 10 x 3 Gy After the baseline measurements have been recorded, the patients will be randomly assigned to one of the two groups: IMRT 10×3 Gy (n = 30) or fractionated conventional 3D-RT 10×3 Gy (n = 30). The RT will be applied daily (mondy to Friday). Follow-up per patient: The target parameters will be measured and recorded at baseline, at the end of RT (t1), and at 12 weeks (t2) and 6 months (t3) after the end of the irradiation period.

Sprave T, Verma V, Förster R, Schlampp I, Hees K, Bruckner T, Bostel T, El Shafie RA, Welzel T, Nicolay NH, Debus J, Rief H.

2018-10-3018 citations

10.1186/s13014-018-1161-4

Quality of Life and Radiation-induced Late Toxicity Following Intensity-modulated <i>Versus</i> Three-dimensional Conformal Radiotherapy for Patients with Spinal Bone Metastases: Results of a Randomized Trial.

Sprave T, Verma V, Förster R, Schlampp I, Hees K, Bruckner T, Bostel T, El Shafie R, Nicolay NH, Debus J, Rief H.

2018-08-0111 citations

10.21873/anticanres.12813

Radiation-induced toxicity after image-guided and intensity-modulated radiotherapy versus external beam radiotherapy for patients with spinal bone metastases (IRON-1): a study protocol for a randomized controlled pilot trial.

Meyerhof E, Sprave T, Welte SE, Nicolay NH, Förster R, Bostel T, Bruckner T, Schlampp I, Debus J, Rief H.

2017-03-033 citations

10.1186/s13063-017-1847-1

Interventions

RADIATIONIMRT

Intensity modulated Raiotherapy (IMRT) of the involved spinal bone metastasis

RADIATIONfractionated RT

external beam Radiotherapy of the involved spinal bone metastasis

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

No

Inclusion criteria

* Patients with a histologically confirmed tumor diagnosis and with secondary diagnosed solitary/multiple spinal bone metastases * Indication for RT of the spinal bone metastases * Age of between 18 and 85 years * Karnofsky index of at least 50 * Signed declaration of informed consent

Exclusion criteria

* Lymphoma * Significant neurological or psychiatric disorders, including dementia and epileptic seizures * Previous RT at the current irradiation site * Other severe disorders that in the judgment of the study director may prevent the patient's participation in the study * Lacking or diminished legal capacity * Any medical of psychological condition that the study director considers a preventive factor for the patient's ability to complete the study or to adequately understand the scope of the study and to give his or her consent.

Design outcomes

Primary

Measure	Time frame	Description
quality of life	3-months-time-point after the end of RT	improvement of more than 10% according to the EORTC BM22 questionaire measured at the 3-months-time-point after the end of RT (t2).

Secondary

Measure	Time frame	Description
bone density	12 weeks post completion radiotherapy	bone density is assessed 12 weeks post completion of radiotherapy using follow-up CT scan of the spine
pain reduction	end of treatment, 12 and 24 weeks post completion of radiotherapy	pain is evaluated using the VAS pain scale (0-100 points) at completion and 12/ 24 weeks post completion of radiation
Fatigue	12 and 24 weeks post completion of therapy	Fatigue is assessed using the EORTC FA13 questionnaire

Countries

Germany

Contacts

Primary ContactHarald Rief, MD, PhD

harald.rief@med.uni-heidelberg.de

Backup ContactJürgen Debus, MD, PhD

juergen.debus@med.uni-heidelberg.de

Outcome results

None listed