IRON-1: Image-guided and Intensity-modulated Radiotherapy Versus External Beam Radiotherapy for Patients With Spine Metastases

Sponsor

Heidelberg University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02832830

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Vertebral Bony Metastases	Radiation: IMRT Radiation: fractionated RT	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2016

Anticipated Primary Completion Date :

Jan 1, 2018

Anticipated Study Completion Date :

Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A intensity modulated radiotherapy (IMRT) 10 x 3 Gy	Radiation: IMRT Intensity modulated Raiotherapy (IMRT) of the involved spinal bone metastasis
Active Comparator: B fractionated conventional external beam RT 10×3 Gy	Radiation: fractionated RT external beam Radiotherapy of the involved spinal bone metastasis

Arm

Intervention/Treatment

Experimental: A

intensity modulated radiotherapy (IMRT) 10 x 3 Gy

Radiation: IMRT

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

Active Comparator: B

fractionated conventional external beam RT 10×3 Gy

Radiation: fractionated RT

external beam Radiotherapy of the involved spinal bone metastasis

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept of Radiation Oncology, University of Heidelberg, Germany	Heidelberg		Germany	69120

Sponsors and Collaborators

Heidelberg University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Heidelberg University

ClinicalTrials.gov Identifier:

NCT02832830

Other Study ID Numbers:

IRON-1

First Posted:

Jul 14, 2016

Last Update Posted:

Jul 14, 2016

Last Verified:

Jul 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Heidelberg University

bony metastases

palliative radiotherapy

Additional relevant MeSH terms:

Neoplasm Metastasis

Neoplasms, Second Primary

Study Results

No Results Posted as of Jul 14, 2016