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

NCT05775146 | Recruiting Phase 2 DMC

• 1 other identifier: IIT-0023
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  Defined as Time from diagnosis to disease progression at any site or death

  From date of diagnosis upto 24 months in follow up

Secondary Outcomes (5)

• Quality of Life (QOL)C309v3

  Baseline QOL will be assessed upto 24 months follow up

• Quality of Life (QOL)EORTC

  Baseline QOL will be assessed upto 24 months follow up

• Cancer Specific Survival (CSS)

  Upto 24 months

• Overall Suvival(OS)

  Expected to be within 3 months post treatment

• Toxicity Assessment

  Toxicity assessment will be done upto 24 months in follow up

Other Outcomes (1)

• Exploratory endpoints/outcomes. To identify blood biomarkers that can correlate with disease events

  Blood samples will be collected at baseline upto 24 months in follow up

Study Arms (1)

SBRT to the metastatic liver +/- lung lesions

EXPERIMENTAL

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.

Radiation: stereotactic body radiation treatment (SBRT)

Interventions

stereotactic body radiation treatment (SBRT) RADIATION

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.

SBRT to the metastatic liver +/- lung lesions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Aswin Abraham

  Cross Cancer Institute, Alberta Health Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aswin Abraham

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: March 20, 2023
• Study Start: June 18, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)