Early Detection of Treatment Failure in Metastatic Colorectal Cancer Patients

Recruiting now

Conditions studied: Colorectal Cancer Metastatic

In brief

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.

Key facts

Study ID

NCT05068531

Run by

Centre hospitalier de l'Université de Montréal (CHUM)

People needed

100

Starts

2022-09-01

Expected to finish

2026-10-01

Last updated by the study team

2024-04-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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