A Prospective Observational Cohort Study for Early Detection of Treatment Failure in Metastatic Colorectal Cancer Patients Undergoing Systemic Chemotherapy and Liver Resection With Curative Intent

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Centre hospitalier de l'Université de Montréal (CHUM)
RECRUITING
Montreal
Contact Information
Primary
Wiam Belkaid, PhD
wiam.belkaid.chum@ssss.gouv.qc.ca
514-890-8000
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2026-10
Participants
Target number of participants: 100
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Centre hospitalier de l'Université de Montréal (CHUM)

This content was sourced from clinicaltrials.gov