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

Launched by AHS CANCER CONTROL ALBERTA · Mar 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Stereotactic Body Radiation Therapy (SBRT) for patients with colorectal cancer that has spread to the liver. The goal is to see if SBRT can be a safe and effective way to manage a small number of liver tumors in patients who have already received other treatments for their colorectal cancer. The trial is currently looking for participants aged 18 and older who have one to five liver lesions that are small enough and located in one part of the liver. Participants should also be planning to have surgery to remove their primary colorectal cancer.

To be eligible for this trial, patients must have liver lesions diagnosed within three months of their colorectal cancer diagnosis and should be healthy enough to participate in the study. They will need to fill out questionnaires about their quality of life during the trial. It's important to note that women who can become pregnant must have a negative pregnancy test, and men must agree not to donate sperm while participating. Patients will receive regular check-ups and monitoring throughout the study to assess their response to the treatment. This trial aims to provide valuable information about using SBRT for managing liver metastases in colorectal cancer patients.

Gender

ALL

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