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RECRUITING

NCT05775146

PHASE2

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

Sponsor: AHS Cancer Control Alberta

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-06-18

Completion Date

2028-06-30

Last Updated

2025-06-27

Healthy Volunteers

Conditions

Colorectal Cancer Liver Metastasis Colon Cancer

Interventions

RADIATION

stereotactic body radiation treatment (SBRT)

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.

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

Locations (1)

Cross Cancer Institute

Edmonton, Alberta, Canada