Bone Metastases Clinical Trial
Official title:
A Phase III Randomized Trial Comparing Stereotactic Body Radiation Therapy (SBRT) vs Conventional Palliative Radiation Therapy for Painful Bone Metastases
To compare increasing doses and different treatment schedules of stereotactic body radiation therapy (SBRT) against standard treatment scheduling.
Primary Objectives: • Pain response will be assessed at 2 weeks, 1 month, 3 months and then every 3 months post-treatment and will be determined based on International Pain Consensus Criteria between the two treatment arms. The 3-month pain response will be used as the primary endpoint in trial design and for powering the test of the study's primary hypothesis of pain response. Secondary Objectives: - The local failure rate will be determined by radiographic response after radiation therapy. If the radiographic reports are indeterminate, the local failure rate will be based on second consecutive radiographic report showing local progression. - To evaluate narcotics utilization converted to OMED (oral Morphine Equivalent Dose) compared to baseline prior to radiotherapy in both treatment arms. - To evaluate rate of re-irradiation in both treatment arms. - To evaluate rate of pathologic fracture in both treatment arms. - To report overall survival, time from end of radiation treatment to date of death from any cause. - To report both acute and long-term toxicity associated with radiotherapy in both treatment arms. - To report of rate of salvage surgery after radiotherapy in both treatment arms. - To report quality of life outcome measures defined in PROMIS study ;
| 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 |