Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562348
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
The ctDNA-RECIST Trial Part One
Sponsor:
None
Organization:
None
Study Overview
Official Title:
ctDNA Guided Palliative Systemic Therapy Compared to Standard Care in Metastatic Cancer - The Randomized ctDNA-RECIST Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
ctDNA-RECIST
Brief Summary:
A study investigating if analysis of circulating tumor DNA ctDNA can guide palliative treatment in patients with gastrointestinal cancer
Detailed Description:
Background
Circulating tumor DNA ctDNA has the potential to better monitor treatment efficacy compared to imaging possibly sparing the patient for ineffective treatment and their associated toxicity an allowing for an early change of the treatment approach
Based on multiple dataset we have defined ctDNA-RECIST - the ctDNA response evaluation criteria
Aim This phase II randomized trial evaluates the use of ctDNA Response Evaluation Criteria in Solid Tumors ctDNA-RECIST versus standard imaging-based RECIST to guide treatment decisions in patients with metastatic gastrointestinal cancers
Design Patients are randomized 11 Patients in Arm A are offered standard treatment with response evaluation according to the RECIST criteria based on imaging and treatment pauses according to institutional guidelines
In Arm B treatment response is evaluated based on change in ctDNA between the baseline sample and the evaluation and confirmation sample according to ctDNA-RECIST
Progressive disease An increase of ctDNA above the previous value with no overlap of the two CIs
Stable disease A value within CI of the previous value The category also includes samples with both previous and present value being 0 undetectable
Partial Response A decrease below the previous value with no overlap of the two CIS but the lower CI does not overlap 0
Complete response Decreasing value to an undetectable level
Near complete response A decrease below the previous value with no overlap of the two CIS and with the lower CI overlapping 0
Complete and near complete response can be combined and classified as maximal response
The study is initiated as a feasibility study part oneand will continue into the expansion trial after interim analysispart two
Circulating tumor DNA ctDNA has the potential to better monitor treatment efficacy compared to imaging possibly sparing the patient for ineffective treatment and their associated toxicity an allowing for an early change of the treatment approach
Based on multiple dataset we have defined ctDNA-RECIST - the ctDNA response evaluation criteria
Aim This phase II randomized trial evaluates the use of ctDNA Response Evaluation Criteria in Solid Tumors ctDNA-RECIST versus standard imaging-based RECIST to guide treatment decisions in patients with metastatic gastrointestinal cancers
Design Patients are randomized 11 Patients in Arm A are offered standard treatment with response evaluation according to the RECIST criteria based on imaging and treatment pauses according to institutional guidelines
In Arm B treatment response is evaluated based on change in ctDNA between the baseline sample and the evaluation and confirmation sample according to ctDNA-RECIST
Progressive disease An increase of ctDNA above the previous value with no overlap of the two CIs
Stable disease A value within CI of the previous value The category also includes samples with both previous and present value being 0 undetectable
Partial Response A decrease below the previous value with no overlap of the two CIS but the lower CI does not overlap 0
Complete response Decreasing value to an undetectable level
Near complete response A decrease below the previous value with no overlap of the two CIS and with the lower CI overlapping 0
Complete and near complete response can be combined and classified as maximal response
The study is initiated as a feasibility study part oneand will continue into the expansion trial after interim analysispart two
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