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Clinical Trials in Canada / NCT05775146
Recruiting Phase 2

SBRT of Metastases Following Neo-adjuvant Treatment for Colorectal Cancer With Synchronous Liver Metastases

NCT05775146 · tracked via the Priya Life Science Canada tracker
Phase
Phase 2
Started
2024-06-18
Last updated
2025-06-27

Condition(s) studied

Colorectal CancerLiver Metastasis Colon Cancer

Investigational drug(s) / intervention(s)

stereotactic body radiation treatment (SBRT)

stereotactic body radiation treatment (SBRT): SBRT uses 3D imaging to target high doses of radiation to the affected area. There is very little damage to the surrounding healthy tissue. SBRT works by damaging the DNA of the targeted cells. Then, the affected cells can't reproduce, which causes tumors to shrink.

Study summary

The purpose of this study is to prospectively evaluate the feasibility of SBRT for the management of synchronous oligo metastatic liver metastases from colorectal cancers.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years * ECOG (Eastern Cooperative Oncology Group) 0-2 * Able to provide written informed consent * 1-5 Liver lesions with max size of ≤5cm for a single lesion and restricted to one lobe of liver; deemed at Multi-Disciplinary Tumor Board (MDT) to be potentially amenable for SBRT with curative intent * Liver lesion identified within 3 months of diagnosis of primary and deemed at Multi-Disciplinary Tumor Board (MDT) to be potentially amenable for SBRT with curative intent * Plan for resection of primary with curative intent * Patients with liver metastases and potentially resectable/ablatable lung mets can be included. * Colon cancer patients who have undergone upfront resection of primary colonic lesion can be included * Able and willing to comply with the terms of the protocol including health-related quality of life (HRQoL) questionnaires * Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level \> 40 mIU/mL to confirm menopause. * Females must not be breastfeeding * Male patients should agree to not donate sperm during the study Exclusion Criteria: * Extra-hepatic metastases (except potentially resectable lung mets) * Not a suitable candidate for liver resection surgery * Not a suitable candidate for SBRT * Past history of cancer within 5 years (except basal cell carcinoma) * Patients who have undergone previous surgery or ablation for liver lesions * Planned simultaneous resection of primary and liver metastases * Pregnancy * Patients with Child-Pugh C and documented cirrhosis

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Cross Cancer Institute Edmonton Alberta Recruiting

More AHS Cancer Control Alberta trials in Canada

Other trials for the same condition

Official registry record

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.

View NCT05775146 on ClinicalTrials.gov ↗ ← All trials in Canada