SBRT of Metastases Following Neo-adjuvant Treatment for Colorectal Cancer With Synchronous Liver Metastases
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
AHS Cancer Control Alberta
24 participants
Jun 18, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria12
- Age ≥ 18 years
- ECOG (Eastern Cooperative Oncology Group) 0-2
- Able to provide written informed consent
- 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 Criteria8
- 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
Interventions
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.
Locations(1)
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NCT05775146