NCT05775146 SBRT of Metastases Following Neo-adjuvant Treatment for Colorectal Cancer With Synchronous Liver Metastases
| NCT ID | NCT05775146 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | AHS Cancer Control Alberta |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-06-18 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 24 participants in total. It began in 2024-06-18 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Aswin Abraham
PRINCIPAL INVESTIGATOR
Cross Cancer Institute, Alberta Health Services
Frequently Asked Questions
Who can join the NCT05775146 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05775146 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05775146 currently recruiting?
Yes, NCT05775146 is actively recruiting participants. Contact the research team at aswin.abraham@albertahealthservices.ca for enrollment information.
Where is the NCT05775146 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT05775146 clinical trial?
NCT05775146 is sponsored by AHS Cancer Control Alberta. The principal investigator is Aswin Abraham at Cross Cancer Institute, Alberta Health Services. The trial plans to enroll 24 participants.
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