NCT02358720

Brief Summary

This study is a prospective, randomized, monocentre, controlled explorative study in the parallel-group design to determine the pain relief after RT of patients with spinal bone metastases. Thereby two different techniques were evaluated: single fraction IMRT with 1 x 24 Gy versus fractionated RT with 10 x 3 Gy. Prior to their enrolment into the study, the patients will undergo a staging of the vertebral column in connection with their radiation-planning computed tomography (CT) and MRI to measure the myelon dimension. After the baseline results have been recorded, the patients will be randomized into one of the two groups: single-fraction IMRT 1 x 24 Gy (n = 30) or fractionated RT 10 x 3 Gy (n = 30). The target parameters will be measured and recorded at baseline, at the end of RT (t1) and twelve weeks (t2) and six months following the end of the irradiation period (t3).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1 pain

Timeline
Completed

Started Dec 2014

Longer than P75 for phase_1 pain

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 9, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 9, 2015

Status Verified

February 1, 2015

Enrollment Period

1 year

First QC Date

January 27, 2015

Last Update Submit

February 6, 2015

Conditions

Pain

Keywords

bone metastases

Outcome Measures

Primary Outcomes (1)

  • pain relief, as measured by visual analog scale (VAS)

    The primary endpoint was defined as pain relief \> 2 points according to visual analog scale (VAS) measured at the irradiated region up to three months after the end of RT

    3 months after therapy completed

Secondary Outcomes (1)

  • quality of life measured on an EORTC BM22 questionnaire

    3 and 6 months after therapy completed

Study Arms (2)

A: single fraction IMRT with 1 x 24 Gy

EXPERIMENTAL

single fraction IMRT with 1 x 24 Gy on bone metastasis

Radiation: Arm A

B: fractionated RT with 10 x 3 Gy

ACTIVE COMPARATOR

fractionated RT with 10 x 3 Gy on bone metastasis

Radiation: Arm B

Interventions

Arm ARADIATION

1x24Gy high dose IMRT on spinal bone metastasis

A: single fraction IMRT with 1 x 24 Gy
Arm BRADIATION

fractionated conformal RT 10 x 3 Gy on spinal bone metastasis

B: fractionated RT with 10 x 3 Gy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a histologically confirmed tumor diagnosis, with secondary diagnosed solitary/multiple spinal bone metastases
  • Indication for RT of the spinal bone metastases
  • Maximal two irradiated vertebral-bodies per region
  • Maximal two different vertebral regions
  • Age: between 18 and 80 years
  • Karnofsky index (10) ≥ 70
  • Signed Declaration of Informed Consent
  • Tumor distance \> 3 mm to myelon

You may not qualify if:

  • Multiple myeloma or lymphoma
  • Significant neurological or psychiatric disorders, including dementia and epileptic seizures
  • Earlier RT at the current irradiated site
  • Other severe disorders that in the judgement 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/her consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Radiation Oncology, University of Heidelberg, Germany

Heidelberg, Germany, 69120, Germany

RECRUITING

Related Publications (8)

  • Coleman RE. Metastatic bone disease: clinical features, pathophysiology and treatment strategies. Cancer Treat Rev. 2001 Jun;27(3):165-76. doi: 10.1053/ctrv.2000.0210.

    PMID: 11417967BACKGROUND

  • Chung Y, Yoon HI, Kim JH, Nam KC, Koom WS. Is helical tomotherapy accurate and safe enough for spine stereotactic body radiotherapy? J Cancer Res Clin Oncol. 2013 Feb;139(2):243-8. doi: 10.1007/s00432-012-1321-0. Epub 2012 Oct 2.

    PMID: 23052695BACKGROUND

  • Nguyen QN, Shiu AS, Rhines LD, Wang H, Allen PK, Wang XS, Chang EL. Management of spinal metastases from renal cell carcinoma using stereotactic body radiotherapy. Int J Radiat Oncol Biol Phys. 2010 Mar 15;76(4):1185-92. doi: 10.1016/j.ijrobp.2009.03.062. Epub 2009 Jul 23.

    PMID: 19632064BACKGROUND

  • Ryu S, Pugh SL, Gerszten PC, Yin FF, Timmerman RD, Hitchcock YJ, Movsas B, Kanner AA, Berk LB, Followill DS, Kachnic LA. RTOG 0631 phase 2/3 study of image guided stereotactic radiosurgery for localized (1-3) spine metastases: phase 2 results. Pract Radiat Oncol. 2014 Mar-Apr;4(2):76-81. doi: 10.1016/j.prro.2013.05.001. Epub 2013 Jun 4.

    PMID: 24890347BACKGROUND

  • Janjan N, Lutz ST, Bedwinek JM, Hartsell WF, Ng A, Pieters RS Jr, Ratanatharathorn V, Silberstein EB, Taub RJ, Yasko AW, Rettenmaier A; American College of Radiology. Therapeutic guidelines for the treatment of bone metastasis: a report from the American College of Radiology Appropriateness Criteria Expert Panel on Radiation Oncology. J Palliat Med. 2009 May;12(5):417-26. doi: 10.1089/jpm.2009.9633.

    PMID: 19416037BACKGROUND

  • Sprave T, Verma V, Forster R, Schlampp I, Hees K, Bruckner T, Bostel T, El Shafie RA, Welzel T, Nicolay NH, Debus J, Rief H. Local response and pathologic fractures following stereotactic body radiotherapy versus three-dimensional conformal radiotherapy for spinal metastases - a randomized controlled trial. BMC Cancer. 2018 Aug 31;18(1):859. doi: 10.1186/s12885-018-4777-8.

    PMID: 30170568DERIVED

  • Sprave T, Verma V, Forster R, Schlampp I, Bruckner T, Bostel T, Welte SE, Tonndorf-Martini E, Nicolay NH, Debus J, Rief H. Randomized phase II trial evaluating pain response in patients with spinal metastases following stereotactic body radiotherapy versus three-dimensional conformal radiotherapy. Radiother Oncol. 2018 Aug;128(2):274-282. doi: 10.1016/j.radonc.2018.04.030. Epub 2018 May 26.

    PMID: 29843899DERIVED

  • Rief H, Katayama S, Bruckner T, Rieken S, Bostel T, Forster R, Schlampp I, Wolf R, Debus J, Sterzing F. High-dose single-fraction IMRT versus fractionated external beam radiotherapy for patients with spinal bone metastases: study protocol for a randomized controlled trial. Trials. 2015 Jun 9;16:264. doi: 10.1186/s13063-015-0761-7.

    PMID: 26054533DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Harald Rief, MD, PhD

    University Hospital Heidelberg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Harald Rief, MD, PhD

CONTACT

+496221568202harald.rief@med.uni-heidelberg.de

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2015

First Posted

February 9, 2015

Study Start

December 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

February 9, 2015

Record last verified: 2015-02

Locations

DE(1)