Recruiting
Phase 2

SBRT

Sponsor:

AHS Cancer Control Alberta

Code:

NCT05775146

Conditions

Colorectal Cancer

Liver Metastasis Colon Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

stereotactic body radiation treatment (SBRT)

Study Details

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.

Conditions

Colorectal Cancer

Liver Metastasis Colon Cancer

Study ID

NCT05775146

Start date

Jun 18, 2024

Status verified date

Jun, 2025

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SBRT to the metastatic liver +/- lung lesions

All rectal cancer patients included in the trial will receive short course radiation to the pelvis (with 25 Gy in 5 fractions) followed by chemotherapy with either 6 cycles of 3 weekly CAPOX chemotherapy or 9 cycles of 2 weekly FOLFOX. All colon cancer patients will receive 6 cycles of 3 weekly CAPOX or 9 cycles of 2 weekly FOLFOX. Patients will proceed for SBRT to the metastatic liver +/\_ lung lesions and resection of the colorectal primary. Treatment planning is to be done using CT simulation or conventional simulation (Fluorocscopy) as per institutional practice. Simple beam arrangements, such as parallel opposed beams, are favored wherever possible.

Interventions

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.

Primary outcome measure

  • Progression free survival (PFS) [ Time Frame: From date of diagnosis upto 24 months in follow up ]

Central Contacts and Locations

Central contacts

Aswin Abraham

780-432-8516aswin.abraham@albertahealthservices.ca

Locations

Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

Contacts

Aswin Abraham

7804328516aswin.abraham@albertahealthservices.ca

More Information

Sponsor

AHS Cancer Control Alberta

Last update posted

Jun 27, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AHS Cancer Control Alberta on 2025-06-27.