Bone Metastases Clinical Trial
Official title:
Prospective Evaluation of Interventional Studies on Bone Metastases - the PRESENT Cohort
Bone metastases are frequent distant manifestations of cancer, with pain as a common and devastating consequence. The primary treatment for painful bone metastases, external beam radiation therapy, is moderately effective: about 60% of patients who undergo conventional radiotherapy experience (partial) pain relief. Several factors associated with treatment failure have been identified, but no attempts have been made to collapse these factors into a clinically useful prediction tool to predict treatment response. In addition, to aid in therapy selection based on expected survival time, development of survival models is essential. Finally, we need innovative treatments as alternatives or additive to standard treatment options to improve quality of life (QoL). For these reasons, we set up the PRESENT cohort study, recruiting patients at the departments of radiation oncology and orthopedic surgery. We aim to provide detailed information about clinical data, create an infrastructure for efficient, fast and pragmatic evaluation and implementation of innovative interventions, as well as development of accurate new prediction tools.
The PRESENT cohort is set up according to the 'cohort multiple Randomised Controlled Trial' design. The basis of this design is a prospective cohort of patients with bone metastases, receiving care as usual, who give informed consent for cohort participation. At the UMC Utrecht, patients are furthermore asked for informed consent to be randomized in future RCTs conducted within the cohort. Patients are informed that they will be offered the experimental intervention if they are randomly selected. They are also informed that they otherwise might serve as controls without being notified and that their data can be used in a trial context. For each patient in the cohort, clinical and patient-reported outcomes are captured at baseline and at regular intervals during follow-up. Within this cohort, multiple RCTs can be conducted. For this purpose, eligible patients who have provided the consent required for them to participate in an RCT within the cohort are identified. From this subcohort, a random selection of patients will be invited to undergo the experimental intervention. Eligible participants who were not randomly selected receive standard care, are not informed about the experimental intervention and serve as controls. Outcomes in this control group are compared with the outcomes of those who were offered the experimental intervention, in order to estimate the effect of the experimental intervention versus usual care. Within the cohort, the same process can be repeated for trials of other interventions. ;
| 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 |