NCT05062317 ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases
| NCT ID | NCT05062317 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Liver Metastases |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-04-26 |
| Primary Completion | 2027-02-28 |
Trial Parameters
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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.
Eligibility Criteria
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