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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Male or female patients (≥18 years of age at the time of consent);
2. Stage IV colon or rectal adenocarcinoma with liver-restricted metastasis(es) for whom partial hepatectomy with curative intent is planned;
3. 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;
4. Patients may undergo planned two-stage partial hepatectomies;
5. 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;
6. 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;
7. Patients are willing and able to provide serial blood samples, tumor and adjacent tissues, and stool samples for research;
8. 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;
9. Patients may receive post-operative adjuvant chemotherapy per SOC, at the discretion of the treating physician;
10. Patients must consent to the Exactis Personalized my Treatment registry.
Exclusion Criteria:
1. Pregnant or breastfeeding patients,
2. Hereditary colorectal cancer (e.g., familial colonic polyposis or Lynch syndrome), and
3. Presence of concurrent other cancer(s).
Primary outcome measure(s)
Radiological response to pre-operative chemotherapy as assessed by RECIST v1.1 — Approximately three months
Biochemical response to pre-operative chemotherapy as assessed by plasmatic CEA measurement, change from baseline after 4 cycles of chemotherapy — Approximately three months
Pathological response to pre-operative chemotherapy as assessed by Ryan and Rubbia Brandt Tumor Regression Grade (TRG) scores on resected tumors — Approximately three months
Tumor response to pre-operative chemotherapy as assessed by change in circulating tumor DNA level, change from baseline — Approximately three months Follow It assay, Canexia Health
Histopathologic growth pattern as assessed by percent replacement, desmoplastic, and pushing features measured at the interface of liver metastasis and non tumoral liver — Three to four months
Post-operative minimal residual disease as assessed by circulating tumor DNA detection after tumor resection with curative intent — Approximately 1 months after resection with curative intent Follow It assay, Canexia Health
Time to radiological recurrence after tumor resection with curative intent — Up to three years after tumor resection with curative intent
Time to biochemical recurrence as assessed by plasmatic CEA measurement, level above the upper limit occurring after tumor resection with curative intent — Up to three years after tumor resection with curative intent
Time to tumor recurrence as assessed by detection or change in level of circulating tumor DNA after tumor resection with curative intent — Up to three years after tumor resection with curative intent Follow It assay, Canexia Health
Trial sites (1)
Facility
City
Region
Status
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal
Quebec
Recruiting
More Centre hospitalier de l'Université de Montréal (CHUM) trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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