Using ctDNA to guide chemotherapy after liver surgery for colorectal cancer
Risk-Stratified Adjuvant Therapy: ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases
This study is testing if checking for tumor DNA in the blood after liver surgery for colorectal cancer can help doctors decide the best follow-up treatment for patients to prevent the cancer from coming back.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | bevacizumab, panitumumab, cetuximab, chemotherapy |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05062317 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone elective hepatectomy for colorectal liver metastases after receiving at least four cycles of preoperative chemotherapy.
Not a fit: Patients with primary colorectal tumors that remain in situ or those unable to undergo postoperative chemotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective postoperative treatment strategies for patients with colorectal liver metastases.
How similar studies have performed: Other studies have shown promising results using ctDNA for monitoring disease recurrence, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.