RECRUITING

CtDNA-Directed Post-Hepatectomy Chemotherapy for Patients with Resectable Colorectal Liver Metastases

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Risk-Stratified Adjuvant Therapy: CtDNA-Directed Post-Hepatectomy Chemotherapy for Patients with Resectable Colorectal Liver Metastases

Quick Facts

Study Start:2022-04-26
Study Completion:2026-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05062317

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Must receive ≥ 4 cycles of preoperative chemotherapy
  1. * Patients with primary colorectal tumor that will remain in situ
  2. * Inability to undergo postoperative chemotherapy, or postoperative chemotherapy not planned a priori
  3. * Unwilling/unable to undergo blood draws for ctDNA, patient or provider-determined
  4. * Other active malignancies requiring treatment
  5. * Women who are pregnant

Contacts and Locations

Study Contact

Timothy Newhook
CONTACT
(713) 794-1001
tnewhook@mdanderson.org

Principal Investigator

Timothy Newhook
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Timothy Newhook, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-26
Study Completion Date2026-02-28

Study Record Updates

Study Start Date2022-04-26
Study Completion Date2026-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Liver Metastases