Recruiting

Observational Study

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT05068531

Conditions

Colorectal Cancer Metastatic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Colorectal Cancer Metastatic

Study ID

NCT05068531

Start date

Sep 1, 2022

Status verified date

Apr, 2024

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

We plan to recruit up to 100 mCRC patients with baseline resectable liver-restricted metastases (mCRC-LR) without evidence of extra-hepatic metastases, with primary tumor already or to be resected (metachronous or synchronous disease), planned to receive upfront FOLFOX-based preoperative neoadjuvant systemic chemotherapy, who achieved no-evidence of disease (NED) in the abdomen by standard imaging.

Primary outcome measure

  • Radiological response to pre-operative chemotherapy as assessed by RECIST v1.1 [ Time Frame: Approximately three months ]
  • Biochemical response to pre-operative chemotherapy as assessed by plasmatic CEA measurement, change from baseline after 4 cycles of chemotherapy [ Time Frame: Approximately three months ]
  • Pathological response to pre-operative chemotherapy as assessed by Ryan and Rubbia Brandt Tumor Regression Grade (TRG) scores on resected tumors [ Time Frame: Approximately three months ]
  • Tumor response to pre-operative chemotherapy as assessed by change in circulating tumor DNA level, change from baseline [ Time Frame: Approximately three months ]
  • Histopathologic growth pattern as assessed by percent replacement, desmoplastic, and pushing features measured at the interface of liver metastasis and non tumoral liver [ Time Frame: Three to four months ]
  • Post-operative minimal residual disease as assessed by circulating tumor DNA detection after tumor resection with curative intent [ Time Frame: Approximately 1 months after resection with curative intent ]
  • Time to radiological recurrence after tumor resection with curative intent [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to three years after tumor resection with curative intent ]

Central Contacts and Locations

Central contacts

Wiam Belkaid, PhD

514-890-8000wiam.belkaid.chum@ssss.gouv.qc.ca

Locations

Centre hospitalier de l'Université de Montréal (CHUM)

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contacts

Wiam Belkaid, PhD

514-836-3273wiam.belkaid.chum@ssss.gouv.qc.ca

Principal Investigator:

Simon Turcotte, MD,MSc

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Apr 18, 2024

Last verified

Apr, 2024

Keywords

  • Real world data
  • Observational study
  • Circulating tumor DNA
  • Microbiome
  • Tumor immunology
  • Metastatic colorectal cancer
  • Liver metastasis
  • Biomarker

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2024-04-18.