Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05862051
Status:
RECRUITING
Last Update Posted:
2023-10-17
First Post:
2022-12-08
Brief Title:
RESOLUTE Trial Aims to Investigate the Value of Adding Local Ablative Treatment to Standard Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer
Sponsor:
Australasian Gastro-Intestinal Trials Group
Organization:
Australasian Gastro-Intestinal Trials Group
Study Overview
Official Title:
Randomised Phase II Trial to Evaluate Progression-Free Survival in Integrating Local Ablative Therapy With First-Line Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer
Status:
RECRUITING
Status Verified Date:
2023-10
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:
RESOLUTE
Brief Summary:
This study aims to assess the clinical benefit of local ablative therapy LAT following initial standard first-line systemic treatment including the impact on survival compared to continued standard first-line systemic treatment for oligometastatic colorectal cancer
Detailed Description:
Who is this study for
Adults with unresectable oligo-metastatic colorectal who have demonstrated treatment benefit partial response or stable disease as per RECIST criteria after 3-4 months of standard first-line systemic treatment
Study details
Participants will be randomly allocated to either a LAT arm who will receive metastasis-directed LAT such as radiotherapy or thermal ablation following initial standard first-line systemic treatment or a control arm who will receive continued first-line systemic treatment alone Those receiving LAT will return to systemic treatment 16 weeks post-randomisation Information on progression-free survival and treatment outcomes will be collected
Data from this study will inform investigators of the potential benefit of local ablative therapy in the therapeutic setting for metastatic colorectal cancer
Adults with unresectable oligo-metastatic colorectal who have demonstrated treatment benefit partial response or stable disease as per RECIST criteria after 3-4 months of standard first-line systemic treatment
Study details
Participants will be randomly allocated to either a LAT arm who will receive metastasis-directed LAT such as radiotherapy or thermal ablation following initial standard first-line systemic treatment or a control arm who will receive continued first-line systemic treatment alone Those receiving LAT will return to systemic treatment 16 weeks post-randomisation Information on progression-free survival and treatment outcomes will be collected
Data from this study will inform investigators of the potential benefit of local ablative therapy in the therapeutic setting for metastatic colorectal cancer
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