Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391242
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-04-17
Brief Title:
Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy for Painful Non-Spine Bone Metastases
Sponsor:
Canadian Cancer Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Randomized Phase III Trial Comparing Stereotactic Body Radiotherapy to Conventional Palliative Radiotherapy SBRT Versus Conventional Palliative Radiotherapy CRT for Participants With Painful Non-Spine Bone Metastases
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being done to answer the following question Is Stereotactic Body Radiation Therapy or SBRT a form of radiation therapy which can deliver high doses of radiation to the specific painful area of the body most affected by cancer while keeping the radiation beams away from the healthy parts of the body that surround the cancer better for pain relief than the standard treatment of conventional radiation therapy or CRT a form of radiation therapy which delivers radiation to the painful area but can also negatively affect other parts of the body in the same area
Detailed Description:
This is a multi-centre phase III randomized controlled trial comparing SBRT to conventional palliative EBRT in patients with solid tumours and a dominant painful non-spine bone metastasis as defined by a worst pain score of 2 or greater 230 participants will be enrolled to the study Participants will have radiation for 5 treatments conventional palliative EBRT 20Gy5 SBRT 30Gy5 or 35Gy5 and then will be followed for pain response and radiological progression at 3 and 6 months post treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None