Risk-Stratified Adjuvant Therapy: ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases
M.D. Anderson Cancer Center
Summary
To determine if the detection of ctDNA after surgical resection of CLM can stratify patients into high and low-risk cohorts for early disease recurrence in order to inform post-operative adjuvant therapy.
Description
Primary Objective: • To assess 1-year recurrence-free survival rate following liver resection of CLM with curative intent among ctDNA-negative patients who receive risk-stratified postoperative chemotherapy Secondary Objectives: * To assess recurrence-free survival following liver resection of CLM with curative intent among ctDNA-positive patients * To assess overall survival following liver resection among ctDNA-negative and ctDNA-positive patients * To evaluate the proportion of ctDNA-negative at 1-year post-resection * To compare survival of ctDNA-negative patients undergoing ctDNA-guide…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients ≥18 years of age with CLM undergoing elective hepatectomy with curative intent (primary colorectal primary cancer previously removed OR being removed at time of hepatectomy) after preoperative chemotherapy (i.e., FOLFOX/FOLFIRI +/- bevacizumab or panitumumab/cetuximab) from 07/01/2021 - 12/31/2023 * Must receive ≥ 4 cycles of preoperative chemotherapy Exclusion Criteria: * Patients with primary colorectal tumor that will remain in situ * Inability to undergo postoperative chemotherapy, or postoperative chemotherapy not planned a priori * Unwilling/unable to un…
Interventions
- DrugLeucovorin
Given by PO
- Drug5-FLUOROURACIL
Given by IV
- DrugOxaliplatin
Given by PO
- DrugIrinotecan
Given by IV
- DrugCapecitabine
Given by IV
- DrugBevacizumab
Given by IV
Location
- M D Anderson Cancer CenterHouston, Texas