An observational study in Colorectal Cancer Metastatic, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-18.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Observational
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.
The general objective of this single-centre, prospective observational cohort study in 100 mCRC-LR patients treated with curative intent along standard of care (SOC), is to obtain real-world data on administered therapies, selected complications, and oncological outcomes, while longitudinally collecting biospecimens to enable correlative research investigating early biological markers of treatment resistance and recurrence.
Cryopreservation of sequential blood derivatives, tumor tissue, and stool samples will allow investigation of circulating tumor DNA (ctDNA), T-cell receptor repertoire, somatic cancer mutations, immune and other gene expression, gut microbiome, and soluble factors.
The first biological marker that will be investigated in correlative research will be longitudinal measurements of ctDNA targeting 30 oncogenes, 23 axons, and 146 hotspots (Follow It assay, Canexia Health). Additional biological markers will be defined in subsequent amendments to this protocol.
The results are expected to provide important insights for the design of future trials investigating ways to personalize therapy, such as to: a) avoid the unnecessary use of neoadjuvant or adjuvant systemic chemotherapy, b) avoid morbid hepatectomies in patients unlikely to benefit, c) test novel preoperative therapies in patients more likely to benefit, and d) modulate the intensity of follow-up.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 100 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 370 studies on the registry; 110 are open to participants now.
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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.
Exclusion Criteria:
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.
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
Follow It assay, Canexia Health
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
Follow It assay, Canexia Health
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
Follow It assay, Canexia Health
Time frame: Up to three years after tumor resection with curative intent
Incidence and grade of FOLFOX-induced neuropathy, as assessed by Sensory Subscale of the NCI CTCAE scale, version 3
Time frame: Two to three months pre-operatively and during post-operative adjuvant chemotherapy
Incidence of allergic reaction to oxaliplatin diagnosed by treating physicians and requiring desensitization or change in chemotherapy regimen
Time frame: Two to three months pre-operatively and during post-operative adjuvant chemotherapy
Incidence of hospitalization for febrile neutropenia diagnosed by treating physicians
Time frame: Two to three months pre-operatively and during post-operative adjuvant chemotherapy
Ninety-day post-surgical complications, defined by Clavien Dindo grading system
Time frame: 90 days after tumor resection
Disease-specific survival after complete tumor resection
Time frame: Up to three years after tumor resection with curative intent
Plan to share: Undecided
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Centre hospitalier de l'Université de Montréal (CHUM)