ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases

Launched by M.D. ANDERSON CANCER CENTER · Sep 29, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether a special test that looks for small pieces of tumor DNA in the blood—called ctDNA—can help doctors identify patients at higher risk for cancer returning after surgery for colorectal cancer that has spread to the liver. The goal is to see if this test can guide doctors in deciding which patients might benefit from additional chemotherapy after their surgery.

To be eligible for the trial, patients need to be at least 18 years old and have had surgery to remove liver tumors that came from colorectal cancer. They should have also received at least four rounds of chemotherapy before their surgery. Patients who are pregnant, have other active cancers, or cannot have blood drawn for the ctDNA test will not be included in the study. Those who join can expect to undergo regular blood tests to monitor their ctDNA levels after surgery and may receive personalized recommendations for further treatment based on their test results.

Gender

ALL

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