Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587490
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Total RadIoTherapy of Oligometastatic caNcerS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Total RadIoTherapy of Oligometastatic caNcerS TRITONS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRITONS
Brief Summary:
This is a Phase III non-blinded randomized study evaluating patients with oligometastatic cancers up to 10 metastases Subjects are randomized 11 to stereotactic ablative radiotherapy SABR plus standard of care therapies versus SABR alone The investigators will measure progression-free survival at 2 years based on the hypothesis that subjects treated with SABR plus standard of care will not experience disease progression for a longer period of time than subjects treated with standard of care alone The investigators will also measure overall survival and safety of SABR as well as biomarkers that may help predict in the future who will benefit from the SABR treatment
Detailed Description:
Patients with metastatic solid malignancies are generally deemed incurable Systemic therapies cytotoxic chemotherapy immunotherapy hormonal therapy etc can be effective for prolonging life but cancers will eventually become resistant prompting transition to second-line therapies that are often more toxic andor more expensive with diminishing oncologic benefit In patients with relatively few detectable metastases SABR to visible tumors may substantially delay progression and thus improve quality of life Unfortunately most patients with metastatic disease will eventually die from their cancer Stereotactic ablative radiotherapy SABR is highly effective often achieving long-term local control Previous studies demonstrated that SABR improves survival and quality of life in patients with oligometastatic cancer However these studies were small and not randomized Thus this randomized study will better evaluate the efficacy and safety of SABR in oligometastatic cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None