Using ctDNA to guide chemotherapy after liver surgery for colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate whether the presence of circulating tumor DNA (ctDNA) after surgical removal of colorectal liver metastases (CLM) can help identify patients at high and low risk for disease recurrence. Patients who are ctDNA-negative will receive risk-stratified postoperative chemotherapy, while ctDNA-positive patients will be monitored for recurrence. The study will assess various outcomes, including recurrence-free survival and overall survival rates, as well as the effectiveness of ctDNA in predicting disease recurrence. Additionally, it will evaluate the impact of chemotherapy on patient quality of life and the occurrence of surgery-related and chemotherapy-related adverse events.

Why it matters

Who can join: the full rules

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

Where it's running

• M D Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Timothy Newhook — M.D. Anderson Cancer Center
• Study coordinator: Timothy Newhook
• Email: tnewhook@mdanderson.org
• Phone: (713) 794-1001

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.