Study on Using ctDNA to Guide Post-Surgery Chemotherapy for Patients with Resectable Colorectal Liver Metastases

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05062317

Provider View

This clinical trial is exploring whether detecting ctDNA after liver surgery can help identify patients at higher risk of cancer returning, to better guide post-surgery chemotherapy treatment.

Patient Parameters

Program Overview

The aim of this study is to find out if checking for ctDNA (a type of DNA found in the blood) after liver surgery for colorectal cancer that has spread to the liver can help doctors decide which patients are more likely to have their cancer come back. This information could help tailor post-surgery chemotherapy treatments to better prevent cancer recurrence.

Description

The main goal of this study is to see how many patients remain free of cancer one year after liver surgery when ctDNA is not detected in their blood and they receive chemotherapy based on their risk level.

Other goals include:

  • Checking how long patients stay cancer-free after surgery if ctDNA is found in their blood.
  • Looking at overall survival rates for patients with and without ctDNA.
  • Seeing how many patients are ctDNA-negative one year after surgery.
  • Comparing survival rates of ctDNA-negative patients who receive ctDNA-guided chemotherapy to past patients.
  • Observing how many patients change their chemotherapy plan based on ctDNA results.
  • Understanding where and how cancer returns.
  • Evaluating how well ctDNA predicts cancer recurrence.
  • Monitoring patient symptoms during chemotherapy using a specific questionnaire (MDASI-GI).
  • Studying the characteristics of tumors and their relation to ctDNA detection.
  • Recording any side effects from surgery and chemotherapy.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with colorectal cancer that has spread to the liver and are having liver surgery to try to cure the cancer.
  • Must have had at least 4 cycles of chemotherapy before surgery.

Exclusion Criteria

  • Patients whose primary colorectal cancer has not been removed.
  • Patients who cannot or will not have chemotherapy after surgery.
  • Patients who cannot or will not have blood tests for ctDNA.
  • Patients with other active cancers needing treatment.
  • Pregnant women.

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