Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06204484
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-11-28
Brief Title:
MRD-guided Deferred Adjuvant Therapy in Resectable Early-stage Colon Cancer
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
The Effectiveness of Deferred Adjuvant Therapy Guided by Dynamic Monitoring Minimal Residue Disease in Resectable High-risk Stage II and Low-risk Stage III Colon Cancer an Open-label Multicenter Phase II Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-01
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:
MIRROR
Brief Summary:
The aim of this clinical trial is to test whether minimal residual disease MRD status detected by circulating tumor DNA ctDNA could be used to guide precision therapy of post-surgery in colon cancer The colon cancers are intended for resectable colon cancer of high-risk stage II and low-risk stage III status The main questions it aims to answer are
1 Whether patients with MRD negative status could benefit from deferred adjuvant therapy
2 Whether patients with MRD positive status need intensive adjuvant therapy The qualified participants will go through two different randomized groups according to the post-surgery 1-month MRD status In MRD negative groups participants will be divided into standard adjuvant therapy groups and deferred adjuvant therapy groups at 12 ratios In MRD positive groups participants will be divided into standard adjuvant therapy groups and intensive adjuvant therapy groups at 12 ratios All the patients will receive MRD detection every 3 months and radiological evaluation every 6 months up to 3 years and survival follow-up up to 5 years
1 Whether patients with MRD negative status could benefit from deferred adjuvant therapy
2 Whether patients with MRD positive status need intensive adjuvant therapy The qualified participants will go through two different randomized groups according to the post-surgery 1-month MRD status In MRD negative groups participants will be divided into standard adjuvant therapy groups and deferred adjuvant therapy groups at 12 ratios In MRD positive groups participants will be divided into standard adjuvant therapy groups and intensive adjuvant therapy groups at 12 ratios All the patients will receive MRD detection every 3 months and radiological evaluation every 6 months up to 3 years and survival follow-up up to 5 years
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None