RecruitingPHASE2INTERVENTIONAL

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

This study is investigating a new way to treat liver tumours that appear at the same time as bowel cancer. It's looking at a special type of radiation therapy called SBRT (Stereotactic Body Radiation Treatment). SBRT is a highly focused radiation treatment that aims to destroy tumours with precision. Researchers want to see if SBRT can be a good option for these liver tumours after patients have had their first round of cancer treatment. The goal is to see if it's safe and effective, potentially offering a less invasive way to treat these tumours, which could lead to a better quality of life and fewer side effects compared to traditional surgery.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

AHS Cancer Control Alberta

Enrolment target

Start

18 Jun 2024

Estimated completion

30 Jun 2028

Colorectal Cancer Liver Metastasis Colon Cancer

What is this study about?

This research study is about finding new and better ways to treat bowel cancer that has spread to the liver when it's first diagnosed. Sometimes, when someone is diagnosed with bowel cancer, doctors also find small cancers (tumours) in the liver at the same time. These are called 'synchronous liver metastases'.

Currently, the usual approach often involves a combination of treatments, starting with chemotherapy. This study is exploring if a highly accurate radiation treatment, called SBRT, can be a useful next step after chemotherapy, before surgery for the main bowel cancer or the liver tumours. SBRT uses strong, focused beams of radiation to target and destroy cancer cells very precisely, trying to avoid damage to healthy surrounding tissue.

The main aim is to see if SBRT is a practical and safe treatment option for these liver tumours. If successful, SBRT could offer a less invasive treatment than surgery for some patients, potentially leading to a quicker recovery, fewer side effects, and an improved quality of life. This is a vital step in learning more about how to best treat these complex cancers.

Key takeaways

This study explores a new radiation treatment (SBRT) for liver tumours in bowel cancer.
It aims to make treatment less invasive and improve quality of life.
Participants will receive standard initial chemotherapy, followed by SBRT, then surgery.
SBRT uses highly focused radiation to target liver tumours precisely.
This is a Phase II study, meaning it's testing safety and effectiveness.

Who may be eligible?

To be considered for this study, you would need to be at least 18 years old and generally well enough to manage your daily activities.

You would need to have between one and five small liver tumours, each no larger than 5cm, all located within one part of your liver. These liver tumours must have been identified within three months of your bowel cancer diagnosis. Your doctors would need to agree that these liver tumours could potentially be treated with SBRT with the aim of curing them. You would also need to be planning to have surgery to remove your main bowel cancer. If your bowel cancer was in the colon and has already been removed, you might still be able to join.

There are also some reasons why you wouldn't be able to join. For example, if your cancer has spread beyond the liver to other organs (except for certain lung tumours that can be treated), if you've already had surgery or other treatments for your liver tumours, or if you've had another cancer in the last five years (excluding harmless skin cancers). Also, if you are pregnant or breastfeeding, you would not be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have between 1 and 5 liver tumours, each less than 5cm, all in one part of your liver?
Are you planning to have surgery for your main bowel cancer?
Have you not had any other cancers in the last 5 years (excluding certain skin cancers)?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first receive your initial cancer treatment, which might involve chemotherapy and sometimes a short course of radiation, depending on where your bowel cancer is located. This will follow standard guidelines and usually lasts a few months.

After this initial treatment, your doctors will do new scans to see how the cancer has responded. If your liver tumours are still present and deemed suitable, you would then receive the SBRT radiation treatment for your liver tumour(s). This is a focused radiation treatment that usually involves a few sessions.

Following SBRT, you would typically have surgery to remove your main bowel cancer. Throughout the study, you would attend regular appointments for checks and scans, and you would also be asked to fill out questionnaires about your health and how you are feeling (quality of life). The total duration of your participation would depend on your individual treatment plan and follow-up schedule.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a focused, potentially less invasive treatment for your liver tumours. SBRT aims to precisely target cancer cells while trying to spare healthy tissues, which could lead to fewer side effects and a better quality of life compared to more extensive surgery. However, like all medical treatments, SBRT has potential risks, including side effects from the radiation, which your medical team will discuss with you. You might also experience side effects from the chemotherapy given before SBRT. It's important to remember that joining a clinical trial means some treatments are still being researched, and we don't yet know all the long-term effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (1)

Cross Cancer Institute
Verified postcode
Edmonton, Canada· Recruiting

Common questions

What is SBRT?

SBRT stands for Stereotactic Body Radiation Treatment. It's a very precise type of radiation therapy that delivers high doses of radiation to a tumour in a few sessions, aiming to destroy the cancer cells while protecting healthy tissue nearby.

What are synchronous liver metastases?

These are small cancer growths (tumours) found in the liver at the same time as a person is diagnosed with bowel cancer.

Will I still have surgery?

Yes, if you participate in this study, the plan is still for you to have surgery to remove your main bowel cancer after the SBRT treatment for your liver tumour(s).

Why is this study important?

This study is important because it's trying to find a new, potentially less invasive and more effective way to treat liver tumours that occur with bowel cancer, which could improve outcomes and quality of life for patients.

What does 'neo-adjuvant treatment' mean?

This refers to the initial treatment (like chemotherapy or radiation) given before the main treatment, such as surgery. It's designed to shrink tumours or kill cancer cells early on.

How to find out more

Aswin Abraham

aswin.abraham@albertahealthservices.ca 780-432-8516 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.