M.D. Anderson Cancer Center
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.
Liver Metastases
Leucovorin
5-FLUOROURACIL
Oxaliplatin
Irinotecan
Capecitabine
Bevacizumab
PHASE2
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
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 120 participants |
| Masking : | NONE |
| Primary Purpose : | TREATMENT |
| Official Title : | Risk-Stratified Adjuvant Therapy: ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases |
| Actual Study Start Date : | 2022-04-26 |
| Estimated Primary Completion Date : | 2026-02-28 |
| Estimated Study Completion Date : | 2026-02-28 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
M D Anderson Cancer Center
Houston, Texas, United States, 77030