Using SBRT to treat liver metastases from colorectal cancer after initial treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial aims to evaluate the feasibility of stereotactic body radiation therapy (SBRT) for managing synchronous oligo-metastatic liver lesions in patients with colorectal cancer. After completing neo-adjuvant treatment, patients will be re-staged and those with non-progressive disease will receive SBRT targeting liver lesions. The study focuses on patients with potentially resectable liver metastases, aiming to provide a minimally invasive treatment option that may improve quality of life and reduce treatment costs. The trial follows established NCCN guidelines for neo-adjuvant therapy in colorectal cancer.

Why it matters

Who can join: the full rules

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

Where it's running

• Cross Cancer Institute
  Edmonton, Alberta, Canada Recruiting

Study contacts

• Principal investigator: Aswin Abraham — Cross Cancer Institute, Alberta Health Services
• Study coordinator: Aswin Abraham
• Email: aswin.abraham@albertahealthservices.ca
• Phone: 780-432-8516

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating a new immuno-adjuvant for colorectal liver metastases after ablation treatments

  This study is testing a new treatment called IP-001 to see if it can boost the immune response and help people with colorectal liver metastases feel better after they have undergone ablation therapies.

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• Comparing simultaneous and staged surgery for colorectal cancer with liver metastases

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• Comparing two treatments for colorectal liver metastases

  This study is testing whether a new treatment called irreversible electroporation works better than stereotactic body radiotherapy for people with hard-to-treat colorectal cancer that has spread to the liver.

  Recruiting Phase 2/3 Amsterdam UMC, location VUmc · Amsterdam, North Holland · NCT06185556

• Neoadjuvant therapy followed by local treatment for recurrent colorectal liver metastases

  This study is testing if giving a new treatment before local therapy can help people with recurrent colorectal liver cancer live longer compared to getting local therapy right away.

  Recruiting Phase 3 Amsterdam UMC, location VUmc · Amsterdam · NCT05861505

• Liver transplantation for patients with non-resectable colorectal liver metastasis

  This study is testing if liver transplants can help people with colorectal cancer that has spread to the liver and can't be removed, to see if it improves their chances of living longer and being cancer-free.

  Recruiting IRCCS Azienda Ospedaliero-Universitaria di Bologna · Bologna · NCT05185245

• Biopsy to study tumor changes after radioembolization

  This study is trying to see how tumors in patients with colorectal cancer that has spread to the liver change after they receive a specific radiation treatment called radioembolization.

  Recruiting Memorial Sloan Kettering Cancer Center · New York, New York · NCT04668872

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.