Liver Metastases
Conditions
Brief 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.
Detailed 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-guided postoperative chemotherapy to historical controls * To evaluate proportion of patients in each arm who change chemotherapy in response to ctDNA measurement * To delineate the pattern of disease recurrence * To assess ctDNA sensitivity and specificity for predicting disease recurrence * To evaluate MDASI-GI during the course of postoperative therapy * To evaluate and correlate patient molecular subtypes and characterization of tumor biologic factors that are associated with ctDNA detection * To evaluate surgery-related adverse events occurring up to 90 days after surgery, and chemo-related adverse events occurring up to 30 days after the last dose of chemotherapy Outcome Measures: Primary: • Recurrence-free survival at 1-year post-hepatectomy among ctDNA-negative patients Secondary: * Recurrence-free survival at 1-year post-hepatectomy among ctDNA-positive patients * Overall survival (OS) among ctDNA-negative and ctDNA-positive patients * ctDNA-negativity at 1-year post-resection * Proportion of patients in each group with chemotherapy regimen change in response to ctDNA dynamics * Pattern of disease recurrence (i.e., liver, systemic, salvageable vs. unsalvageable) * ctDNA sensitivity/specificity for recurrent disease overall by timepoint * MDASI-GI at clinic visits during course of postoperative therapy * Tumor radiologic, histologic, and molecular profiling and correlative characterization based upon ctDNA detection * Adverse events
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
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 undergo blood draws for ctDNA, patient or provider-determined * Other active malignancies requiring treatment * Women who are pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish the 1-year recurrence-free survival rate following liver resection of CLM with curative intent among ctDNA-negative patients who receive risk-stratified postoperative chemotherapy | through study completion, an average of 1 year |
Countries
United States
Contacts
CONTACTTimothy Newhook
PRINCIPAL_INVESTIGATORTimothy Newhook
M.D. Anderson Cancer Center
Outcome results
None listed