REACT-CLM: Risk-Stratified Adjuvant Therapy: ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases
The study will focus on patients with liver metastases from colorectal cancer who are eligible for liver surgery, have received chemotherapy before surgery, and have had their primary colorectal tumor removed.
This study aims to find out if a certain type of DNA called circulating DNA (ctDNA) can help doctors identify patients who are at high or low risk of their cancer coming back after surgery to remove liver metastases from colorectal cancer (cancer that has spread to the liver). Researchers believe that by detecting ctDNA after surgery, they can separate patients into high-risk (ctDNA+) and low-risk (ctDNA-) groups for early recurrence of the disease. They think that patients in the low-risk group who do not have ctDNA present will have a longer time before their cancer comes back, regardless of the type of chemotherapy they receive after the liver surgery, as long as they had chemotherapy before the surgery. This risk-based approach to post-operative therapy could allow patients without detectable ctDNA levels to receive less intense chemotherapy after surgery, avoiding the side effects of more aggressive chemotherapy. It would also keep other treatment options available for later use. Additionally, changes in ctDNA levels over time after surgery may help doctors adjust treatment strategies to prevent or delay the return of the cancer. The main outcome the researchers will measure is the proportion of patients who do not have signs of the cancer coming back on radiographic images after one year.
The study will focus on patients with liver metastases from colorectal cancer who are eligible for liver surgery, have received chemotherapy before surgery, and have had their primary colorectal tumor removed.
Study Schema:
Study Intervention Timeline :
Key Eligibility 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
See ClinicalTrials.gov for more details:
Drug: Leucovorin
- Given by PO
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Other Names:
- Citrovorum
- Wellcovorin®
Drug: 5-FLUOROURACIL
- Given by IV
Drug: Oxaliplatin
- Given by PO
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Other Names:
- Eloxatin
Drug: Irinotecan
- Given by IV
Drug: Capecitabine
- Given by IV
-
Other Names:
- Xeloda
Drug: Bevacizumab
- Given by IV
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Other Names:
- Avastin™
- Anti-VEGF monoclonal antibody
- rhuMAb-VEGF