Using SBRT to treat liver metastases from colorectal cancer after initial treatment
Phase II Single Arm Feasibility Trial to Evaluate Stereotactic Ablative Radiation of Metastases for the Management of Colorectal Cancer With Synchronous Oligo-metastases in Liver
This study is testing if a special type of radiation therapy can help people with liver tumors from colorectal cancer feel better after their initial treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AHS Cancer Control Alberta Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT05775146 on ClinicalTrials.gov |
What this trial studies
This phase II trial aims to evaluate the feasibility of stereotactic body radiation therapy (SBRT) for managing synchronous oligo-metastatic liver lesions in patients with colorectal cancer. After completing neo-adjuvant treatment, patients will be re-staged and those with non-progressive disease will receive SBRT targeting liver lesions. The study focuses on patients with potentially resectable liver metastases, aiming to provide a minimally invasive treatment option that may improve quality of life and reduce treatment costs. The trial follows established NCCN guidelines for neo-adjuvant therapy in colorectal cancer.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with 1-5 liver lesions from colorectal cancer that are potentially amenable to SBRT and who plan to undergo surgery for the primary cancer.
Not a fit: Patients with progressive disease or those with liver lesions not suitable for SBRT will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a less invasive treatment option with improved outcomes for patients with liver metastases from colorectal cancer.
How similar studies have performed: Other studies have shown promise with SBRT for liver metastases, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Edmonton, Alberta
- Cross Cancer Institute — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Aswin Abraham — Cross Cancer Institute, Alberta Health Services
- Study coordinator: Aswin Abraham
- Email: aswin.abraham@albertahealthservices.ca
- Phone: 780-432-8516
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.