Bone Metastases Clinical Trial
Official title:
Randomized Controlled Trial Comparing Conventional Radiotherapy With Stereotactic Body Radiotherapy in Patients With Bone Metastases - VERTICAL Study
The purpose of the study is to investigate effectiveness of stereotactic body radiotherapy in patients with bone metastatic disease.
Rationale: Bone metastases are a frequent distant manifestation of solid tumours, and many bone metastases are located in the spine. These patients mostly present with severe (back) pain which reduces quality of life. The primary treatment for pain management is a single-fraction low dose external beam radiation therapy (EBRT), effective in achieving pain reduction in around 60% of patients, of whom 0-23% experience complete pain response. Recently, there is growing evidence that Stereotactic Body Radiotherapy (SBRT) achieves a much higher pain response due to the higher dose administered. In retrospective and a few prospective case series, SBRT for spinal, and also non-spinal metastases has been demonstrated to be safe, and efficacious. However, no randomized controlled trials have been performed. Objective: To study whether the pain response after three months in patients with osseous metastatic disease increases after SBRT in comparison to low dose EBRT. Study design: Randomized controlled trial, the VERTICAL study, nested within the PRESENT cohort. Study population: Eligible patients are MRI-compatible patients with radiographic evidence of bone metastases at the radiotherapy department. Fifty-five patients are recruited in both control and intervention arm. Intervention: Patients will undergo MRI-based, cone beam CT-guided SBRT and will receive a single dose of 18 Gray (Gy) on the visible metastasis, and 8 Gy on the bony compartment containing the metastasis (e.g. the affected vertebra or pedicle). Main study parameters/endpoints: The primary endpoint is pain control at three months after radiotherapy. Secondary outcomes are, among others, the occurrence of vertebral compression fracture (VCF) and radiation-induced myelopathy, local tumour control and evaluation of quality of life. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03986593 -
Cryoablation of Bone Metastases From Endocrine Tumors
|
N/A | |
Active, not recruiting |
NCT01996046 -
FDG PET/CT in Breast Cancer Bone Mets
|
||
Completed |
NCT01358539 -
Palliation: the Effect of Education on Pain
|
Phase 3 | |
Terminated |
NCT00981578 -
ExAblate Conformal Bone System Treatment of Metastatic Bone Tumors for the Palliation of Pain
|
N/A | |
Terminated |
NCT00757757 -
A Phase I/II Open-label Study of MCS110 in Patients With Prostate Cancer and Bone Metastases
|
Phase 1/Phase 2 | |
Completed |
NCT00762346 -
Efficacy and Safety Study of ZOMETA® in Treatment of High-level NTX Non Small Cell Lung Cancer With Bone Metastasis
|
Phase 4 | |
Completed |
NCT00420433 -
Bone Response in Metastatic Breast Cancer Involving Bones
|
N/A | |
Completed |
NCT02826382 -
Preliminary Evaluation of Uptake in Bone Metastases and Biodistribution of [68Ga]P15-041
|
Early Phase 1 | |
Terminated |
NCT05301062 -
A Research Called CREDIT Studies How Safe the Study Treatment Radium-223 is and How Well it Works in Chinese Men With Advanced Prostate Cancer That Has Spread to the Bones and Does Not Respond to Treatments for Lowering Testosterone Levels
|
||
Recruiting |
NCT06367491 -
National Database of Bone Metastases
|
||
Completed |
NCT03223727 -
Treatment Outcomes in a Non-study Population of Symptomatic mCRPC Patients Treated With Radium-223
|
||
Completed |
NCT00830180 -
Open Label Extension In Cancer Patients
|
Phase 2 | |
Active, not recruiting |
NCT03305224 -
The Combination Therapy With Ra-223 and Enzalutamide
|
Phase 2 | |
Withdrawn |
NCT04109937 -
External Beam Radiation Therapy Post Surgery in Patients With Lower Extremity Bone Metastases Randomized Efficacy Trial
|
N/A | |
Active, not recruiting |
NCT02880943 -
Dose-finding, Safety and Efficacy Study of Radium-223 Dichloride (XOFIGO) in RCC Patients With Bone Metastases. (EIFFEL)
|
Phase 1/Phase 2 | |
Completed |
NCT01696760 -
Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology
|
N/A | |
Completed |
NCT00958477 -
A Study to Determine the Safety, Tolerability, Pharmacokinetics and Dynamic Effects of Different Doses of the Study Drug EMD 525797 in Prostate Cancer
|
Phase 1 | |
Completed |
NCT03979118 -
Exercise Prescription in Patients With Bone Metastases
|
||
Completed |
NCT03353090 -
Double-bed SPECT/CT for Bone Scintigraphy in Initial Staging of Cancer Patients
|
N/A | |
Recruiting |
NCT05167669 -
Pain Relief in Symptomatic Bone Metastases With Adjuvant Hyperthermia MR Guided HIFU
|
Early Phase 1 |