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TAS-102 in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy

Colorectal Cancer Clinical Trial

Official title:
TAS-102 in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy

Clinical Trial Summary

To measure the level of circulating tumor DNA (ctDNA) in the blood of colorectal cancer patients after 6 months of receiving TAS-102 therapy. ctDNA is genetic material from tumor cells that can be found and measured in the blood.

Clinical Trial Description

Primary Objectives: The primary objective is to determine the 6-month ctDNA clearance rate in colorectal cancer patients with minimal residual disease following 6 months of TAS-102 therapy. Secondary Objectives: - To determine the 3-month ctDNA clearance rate in colorectal cancer patients with minimal residual disease. - To determine the disease free survival (DFS) amongst colorectal cancer patients with minimal residual disease following 6 months of TAS-102 therapy. - To determine the overall survival (OS) amongst colorectal cancer patients with minimal residual disease following 6 months of TAS-102 therapy. - To determine the safety and tolerability of TAS-102 for the treatment of colorectal cancer patients with minimal residual disease. Exploratory Objectives: - To determine markers of response and resistance in archival tumor tissue including but not limited to immune profiles of tumor-infiltrating lymphocytes, expression of immune markers in tumor cells and microenvironment, and molecular markers (including but not limited to mutations, deletions, and/or amplifications or cancer molecular subtype) - To determine changes in profiles of circulating lymphocytes and ctDNA with treatment - To determine baseline characteristics in archival tumor and/or plasma that may predict clinical benefit ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05343013
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Suspended
Phase Phase 2
Start date June 6, 2022
Completion date May 15, 2025
View Details
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