Early Detection of Treatment Failure in Metastatic Colorectal Cancer Patients

What this study is about

In North America, colorectal cancer patients with resectable liver-restricted metastases (mCRC-LR) are treated with approximately 6 months of preoperative systemic multi-agent chemotherapy. Actuarial data however supports that approximately 20% of mCRC-LR patients can be cured without as much systemic chemotherapy. Prospective phase II-III trials also support that awaiting recurrence to initiate further metastases-targeted or systemic treatment may provide patients with longer overall survival while avoiding toxicities in those without recurrence.

Who can join (things the study team will check)

✅ You may be able to join if…

• Male or female patients (≥18 years of age at the time of consent);
• Stage IV colon or rectal adenocarcinoma with liver-restricted metastasis(es) for whom partial hepatectomy with curative intent is planned;
• Instead of, or in addition to, partial hepatectomy, liver metastases may be ablated by needle radio frequency or microwave; in case of a solitary liver metastasis, three core-needle biopsies are provided for research at time of the procedure and prior to tissue destruction;
• Patients may undergo planned two-stage partial hepatectomies;
• Patients may have at baseline lung micro nodules or intra-abdominal enlarged nodes or nodules of unknown nature, not considered as extra-hepatic metastases in the opinion of the investigator;
• Patients who are scheduled to receive FOLFOX-based pre-hepatectomy may receive any additional combined agents, such as and not limited to Irinotecan, anti-EGFR, and anti-VEGF drugs;
• Patients are willing and able to provide serial blood samples, tumor and adjacent tissues, and stool samples for research;
• The timing and specific treatments of the primary colon or rectal tumor is per SOC, at the discretion of the treating physician, including the use of pre-operative radiotherapy for rectal cancer;
• Patients may receive post-operative adjuvant chemotherapy per SOC, at the discretion of the treating physician;
• Patients must consent to the Exactis Personalized my Treatment registry.

🚫 You may not be able to join if…

• Pregnant or breastfeeding patients,
• Hereditary colorectal cancer (e.g., familial colonic polyposis or Lynch syndrome), and
• Presence of concurrent other cancer(s).

Where this trial is running

• Centre hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada

Who to contact

Wiam Belkaid, PhD · 514-890-8000 · wiam.belkaid.chum@ssss.gouv.qc.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05068531.