Focused Ultrasound and RadioTHERapy for Noninvasive Palliative Pain Treatment in Patients With Bone Metastases

Who is this study for? Adult patients with Cancer-Induced Bone Pain
What treatments are being studied? Magnetic Resonance-Guided Intensity-Focused Ultrasound
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure, Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The FURTHER study aims to evaluate the effectiveness and cost-effectiveness of MR-HIFU (alone or in combination with EBRT) compared to EBRT alone, the standard-of-care, as a palliative treatment option to relieve CIBP. The FURTHER study consists of a multicenter, three-armed randomized controlled trial (FURTHER RCT) and a patient registry arm (FURTHER Registry), which will be performed in six hospitals in four European countries.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient capable of giving informed consent

• Age ≥ 18 years

• Painful metastatic bone lesion (NRS \> 2)

• Patient-localised pain with a distinct pathological substrate on recent CT/MRI

• Target lesion location is sufficiently accessible for MR-HIFU to expect clinical response, as judged by the (intervention) radiologist

• Participant has a reasonable performance score (KPS ≥ 50% or Zubrod/ECOG/WHO \< 3)

• Life expectancy ≥ 3 months

Locations
Other Locations
Finland
TUCH Turku
RECRUITING
Turku
Germany
University Hospital Cologne
RECRUITING
Cologne
Italy
IOR
RECRUITING
Bologna
CSSP
RECRUITING
Roma
Netherlands
University Medical Center Utrecht
RECRUITING
Utrecht
Isala Klinieken Zwolle
RECRUITING
Zwolle
Contact Information
Primary
Renée Hovenier, MSc
r.hovenier-2@umcutrecht.nl
+31 6 5017 78 43
Backup
Helena M Verkooijen, MD, PhD
h.m.verkooijen@umcutrecht.nl
+31 88 75 595 75
Time Frame
Start Date: 2020-03-10
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 216
Treatments
Active_comparator: External Beam Radiotherapy
In the control arm, patients will undergo standard radiotherapy for painful bone metastases.The radiation schedule is at the discretion of the treating radiation oncologist.
Experimental: MR-HIFU
In the intervention arm, patients will be offered MR-HIFU treatment instead of standard radiotherapy. Treatment will be given following the international guidelines for MR-HIFU.
Experimental: Combination EBRT + MR-HIFU
In the combination arm, patients will undergo standard radiotherapy followed by MR-HIFU in a short timeframe.
Authors
Marcia MT Bartels
Related Therapeutic Areas
Sponsors
Collaborators: University of Roma La Sapienza, Istituto Ortopedico Rizzoli, Turku University Hospital, Isala, Universitätsklinikum Köln, University of Bologna
Leads: UMC Utrecht

This content was sourced from clinicaltrials.gov