SBRT of Metastases Following Neo-adjuvant Treatment for Colorectal Cancer With Synchronous Liver Metastases
Recruiting now · Phase 2
Conditions studied: Colorectal Cancer, Liver Metastasis Colon Cancer
In brief
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.
Key facts
- Study ID
- NCT05775146
- Run by
- AHS Cancer Control Alberta
- People needed
- 24
- Starts
- 2024-06-18
- Expected to finish
- 2028-06-30
- Last updated by the study team
- 2025-06-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Cross Cancer Institute — Edmonton, Alberta, Canada (enrolling)
Full record on ClinicalTrials.gov
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