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.
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcomes of the trial will be pain response at 14 days after completion
of the treatment, and pain response at 14 days after inclusion. Secondary
outcomes include pain scores, toxicity, adverse events, quality of life and
survival in the first 6 months after treatment, and cost-effectiveness of the
treatments.
Secondary outcome
Secondary outcomes include pain scores, toxicity, adverse events, quality of
life and survival in the first 6 months after treatment, and cost-effectiveness
of the treatments.
Background summary
Cancer induced bone pain (CIBP) as a result of bone metastases strongly
interferes with quality of life and daily functioning of patients with advanced
cancer. The current standard of care for patients with painful bone metastasis
includes palliative external beam radiotherapy (EBRT). While EBRT is a
well-established treatment option, it takes up to 4-6 weeks for EBRT to induce
optimal pain relief, and 30-40% of patients do not respond to EBRT. Pain
palliation may be improved by including magnetic resonance image guided high
intensity focused ultrasound (MR-HIFU) as alternative or in addition to EBRT.
Study objective
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.
Study design
The FURTHER study consists of a prospective, multicenter, three-armed
randomized controlled trial (FURTHER RCT) and a patient registry arm (FURTHER
Registry), performed in six hospitals in four European countries, all of which
are partners in the FURTHER consortium. The UMC Utrecht is coordinating center.
A total of 216 patients with painful bone metastases will be randomized in a
1:1:1 ratio to receive EBRT only, MR-HIFU only, or EBRT followed by MR-HIFU. In
the Netherlands, we expect to enroll a minimum of 70 patients, and a maximum of
120 patients in three Dutch study sites. Within the FURTHER Registry, data of
around 60-90 patients will be captured.
Intervention
The intervention under study is MR-HIFU alone or in combination with EBRT. The
intervention is aimed at rapid and persistent relief of CIBP.
Study burden and risks
In terms of benefits, patients participating in this study may experience a
more rapid pain relief as a result of the MR-HIFU intervention. In terms of
burden, patients in the intervention arms will possibly need to pay an extra
visit or visits to the hospital, they will undergo a rather lengthy
(additional) intervention (MR-HIFU treatment) under sedation or anaesthesia. In
addition, all study participants will have to fill in a daily pain diary during
the first 21 days after treatment and quality of life questionnaires at six
time-points in the follow up period. Serious adverse events due to the
intervention are not to be expected.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Age >= 18 years
Patient capable of giving informed consent
Painful metastatic bone lesion (NRS >= 2)
Patient-localised pain with a distinct pathological substrate on recent CT/MRI
Target lesion location is >75% accessible for MR-HIFU
Participant able to fit in the MRI gantry
Reasonable performance score (KPS > 50% or Zubrod/ECOG/WHO < 3)
Life expectancy > 3 months
Exclusion criteria
Need for surgery of targeted location due to (impending) pathological fracture
Unavoidable critical structures or dense tissues in target area *
Contra indications MRI or sedation/anaesthesia
Participant enrolled in another clinical interventional study related to bone
metastases treatment or pain relief treatment
Clinically relevant medical history or physical findings that could interfere
with the patient's safety as judged by the treating physician
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL71303.041.19 |