MRI-Guided SBRT for Colorectal Cancer with Liver Metastases

Recruiting at 6 trial locations

Overseen By Neelam Tyagi, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Antineoplastics

Disqualifiers: Cirrhosis, Hepatic radioembolization, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating colorectal cancer that has spread to the liver. It uses a high-dose, precise form of radiation therapy guided by MRI images, known as MR Guided Single Fraction Stereotactic Body Radiation Therapy (SBRT), to determine if it can stop the cancer from growing and spreading. Researchers are also monitoring side effects and assessing whether certain MRI features can predict the treatment's effectiveness. Suitable candidates for this trial include those with colorectal cancer that has spread to the liver and have up to three liver tumors, each smaller than 5 cm. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants, offering a chance to benefit from cutting-edge therapy.

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) of 2 weeks for prior chemotherapy and 1 week or 4 half-lives for biologics or targeted therapies, whichever is longer. You may need to stop some medications before participating.

What prior data suggests that MRI-guided SBRT is safe for treating colorectal cancer with liver metastases?

Research has shown that MRI-guided SBRT, a precise type of radiation therapy, is generally well-tolerated by patients with liver cancer spread from colorectal cancer. In one study, 97% of treatments proceeded smoothly without major issues. Only one participant experienced a serious side effect, rated as grade 3, indicating it was moderate to severe but not life-threatening. This suggests that most patients can handle the treatment well, with few severe side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for colorectal cancer with liver metastases?

Researchers are excited about MR Guided Single Fraction Stereotactic Body Radiation Therapy (SBRT) for colorectal cancer with liver metastases because it offers a highly precise and targeted approach. Unlike traditional radiation therapies, which may require multiple sessions and larger treatment margins, this technique uses MRI guidance to deliver a single, concentrated dose of radiation directly to the tumor. This minimizes damage to surrounding healthy tissue and potentially reduces treatment time. Additionally, the use of on-line adaptive replanning during the procedure allows for adjustments in real time, enhancing accuracy and potentially improving outcomes for patients with complex metastatic cancer.

What evidence suggests that MRI-guided SBRT is effective for colorectal cancer with liver metastases?

Research has shown that MR-guided stereotactic body radiation therapy (SBRT) can effectively target cancer that has spread to the liver from colorectal cancer. This method enables doctors to deliver precise, high-dose radiation directly to the tumor while protecting healthy tissue. One study found that 97% of treatments were well tolerated, and most were completed successfully. Patients receiving SBRT often experience few severe side effects, making it a promising treatment option. This trial will evaluate the effectiveness of MR-guided SBRT in controlling cancer spread in the liver, which is crucial for patients with colorectal cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Marsha Reyngold, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with colorectal cancer that has spread to the liver. They must have good liver function, not be pregnant or breastfeeding, and agree to use contraception. People can't join if they have cirrhosis, certain prior treatments like radioembolization, are unable to undergo MRI scans due to implants or claustrophobia, or are on other cancer therapies within a week of starting this study.

Inclusion Criteria

My colorectal cancer has spread to my liver.

My lesion is at least 2 cm away from the main blood vessels in my liver.

My lesion is located in my stomach or intestines, at least 1.5 cm inside.

Exclusion Criteria

I have a history of cirrhosis.

I have had liver-targeted radiation therapy.

I am not using any form of birth control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Simulation and Planning

Participants undergo simulation including Gd-EOB-DTPA-enhanced MR and planning using minimal margins

1-2 weeks

1 visit (in-person)

Treatment

Participants receive a single fraction of 40Gy SBRT guided by MRI

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• MR Guided Single Fraction Stereotactic Body Radiation Therapy (SBRT)

Trial Overview

The trial tests whether one session of high-dose MRI-guided SBRT (a type of targeted radiation therapy) can effectively treat liver metastases from colorectal cancer without causing significant growth or spread. The effectiveness and side effects will be monitored along with any predictive factors in MRI images.

How Is the Trial Designed?

Group I: MR Guided Single Fraction Stereotactic Body Radiation Therapy (SBRT) Experimental Treatment 1 Intervention

Participants will undergo simulation including Gd-EOB-DTPAenhanced MR and planning using minimal margins. Ten days later (+/- 3 days) participants will receive 40Gy single fraction treatment on Elekta Unity using Gd-EOB-DTPA-enhanced MR for image guidance and on-line adaptive replanning.

MR Guided Single Fraction Stereotactic Body Radiation Therapy (SBRT) is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

Approved in United States as Stereotactic Body Radiation Therapy for:

• Liver metastases from colorectal cancer

Approved in European Union as Stereotactic Body Radiation Therapy for:

• Liver metastases from colorectal cancer

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Liver metastases from colorectal cancer

Approved in Japan as Stereotactic Body Radiation Therapy for:

• Liver metastases from colorectal cancer

Approved in China as Stereotactic Body Radiation Therapy for:

• Liver metastases from colorectal cancer

Approved in Switzerland as Stereotactic Body Radiation Therapy for:

• Liver metastases from colorectal cancer

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Elekta Limited

Industry Sponsor

Trials

13

Recruited

8,900+

Published Research Related to This Trial

Online-adaptive MRI-guided stereotactic body radiation therapy (SBRT) allows for better dose escalation to tumors while simultaneously protecting surrounding organs at risk (OARs), as shown in a study of 10 patients with oligometastatic disease.

The adaptive planning improved planning target volume (PTV) coverage in 21 out of 30 cases, demonstrating its potential to enhance treatment effectiveness compared to traditional nonadaptive SBRT methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simulated Online Adaptive Magnetic Resonance-Guided Stereotactic Body Radiation Therapy for the Treatment of Oligometastatic Disease of the Abdomen and Central Thorax: Characterization of Potential Advantages. Henke, L., Kashani, R., Yang, D., et al.[2022]

In a study involving 56 patients treated with Magnetic Resonance guided Radiotherapy (MRgRT) for primary liver tumors, no severe toxicities (greater than CTCAE grade 2) were observed, indicating a high safety profile for this treatment.

MRgRT achieved excellent local control rates of 98.1% at 12 months and 94.7% at 18 months, with an overall survival rate of 85.1% at 1 year, demonstrating its efficacy in managing primary liver tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective registry study of stereotactic magnetic resonance guided radiotherapy (MRgRT) for primary liver tumors. Bordeau, K., Michalet, M., Dorion, V., et al.[2023]

In a study of 26 patients with liver tumors treated using MR-guided stereotactic body radiation therapy (SBRT), no severe gastrointestinal toxicities (grade 4 or higher) were observed, indicating a high safety profile for this treatment approach.

The treatment demonstrated excellent local control with an 80.4% freedom from local progression at a median follow-up of 21.2 months, suggesting that MR guidance allows for effective targeting of tumors while sparing healthy tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multi-Institutional Experience of MR-Guided Liver Stereotactic Body Radiation Therapy. Rosenberg, SA., Henke, LE., Shaverdian, N., et al.[2022]

In a study involving 10 patients with liver metastases, MR-guided stereotactic body radiotherapy (MRgSBRT) demonstrated excellent visibility of tumors without the need for fiducial markers, indicating a promising non-invasive treatment option.

The treatment was well-accepted by patients, with no reported cases of symptomatic radiation-induced liver disease after a median follow-up of 10 months, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Marker-less online MR-guided stereotactic body radiotherapy of liver metastases at a 1.5 T MR-Linac - Feasibility, workflow data and patient acceptance. Gani, C., Boeke, S., McNair, H., et al.[2022]

The study demonstrated that online adaptive MR-guided stereotactic body radiation therapy (SBRT) is feasible and well-tolerated in 25 patients with unresectable upper abdominal tumors, with 84% of treatment fractions completed within 60 minutes.

No severe acute toxicity (grade 3 or higher) was reported, and the treatment successfully alleviated pain in 11 out of 13 patients, indicating both safety and efficacy in symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online adaptive MR-guided stereotactic radiotherapy for unresectable malignancies in the upper abdomen using a 1.5T MR-linac. Daamen, LA., de Mol van Otterloo, SR., van Goor, IWJM., et al.[2022]

The study involving 12 patients with lymph node oligometastases demonstrated that hypofractionated radiotherapy using the 1.5T MR-linac system is feasible, with most pre-treatment plans meeting clinical dose criteria for different fractionation schemes.

However, the quality of treatment plans varied, with single fraction treatments (1x20 Gy) generally being of lesser quality compared to multiple fractions (5x7 Gy and 3x10 Gy), highlighting the importance of considering the target's location relative to critical structures when selecting a treatment plan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric feasibility of hypofractionation for SBRT treatment of lymph node oligometastases on the 1.5T MR-linac. Winkel, D., Werensteijn-Honingh, AM., Eppinga, WSC., et al.[2021]

In a study of 51 patients treated with online MR-guided stereotactic body radiotherapy (SBRT) for liver metastases, the treatment demonstrated a high local control rate of 89.6% after 12 months, indicating its efficacy in managing liver tumors.

The treatment was well-tolerated with no acute grade ≥ 3 toxicities reported, and patient quality of life remained stable, suggesting that MRgRT is a safe and noninvasive option for patients with liver metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local control and patient reported outcomes after online MR guided stereotactic body radiotherapy of liver metastases. Uder, L., Nachbar, M., Butzer, S., et al.[2023]

In a study of 20 patients with liver metastases or hepatocellular carcinoma, MR-guided stereotactic body radiation therapy (SBRT) achieved an impressive local control rate of 88.1% and overall survival rate of 84.0% at one year, indicating its efficacy as a treatment option.

The treatment was well-tolerated, with only mild gastrointestinal toxicity reported (30% grade I and 5% grade II), and patients generally had a positive experience, although some concerns were noted regarding treatment duration and positioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance-Guided Stereotactic Body Radiotherapy of Liver Tumors: Initial Clinical Experience and Patient-Reported Outcomes. Weykamp, F., Hoegen, P., Klüter, S., et al.[2022]

The study successfully demonstrated the technical feasibility of 4D-MRI guided stereotactic body radiation therapy (SBRT) for liver metastases in 20 patients, with all but one meeting the feasibility criteria and no severe acute toxicity observed.

Despite the successful implementation, significant mid-position drifts were noted during treatment, highlighting the need for improved intra-fraction motion management strategies to enhance treatment precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical feasibility and clinical evaluation of 4D-MRI guided liver SBRT on the MR-linac. van de Lindt, TN., Nowee, ME., Janssen, T., et al.[2022]

In a study involving 20 patients with liver tumors, MR-guided stereotactic body radiation therapy (SBRT) demonstrated high local control rates of 94.7% at one year and 79.6% at two years, indicating its efficacy in treating both primary and secondary liver tumors.

The treatment was well-tolerated, with no acute severe toxicities (grade ≥3) reported, and only one case of late severe toxicity, suggesting that MR-guided SBRT is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ablative radiotherapy for liver tumors using stereotactic MRI-guidance: A prospective phase I trial. van Dams, R., Wu, TC., Kishan, AU., et al.[2022]

In a study of 40 patients treated with MR-guided stereotactic body radiotherapy (SBRT) for liver metastases, the treatment showed promising long-term local control rates of 98% at 1 year and 75% at 2 years, especially for doses greater than 100 Gy biologically effective dose (BED).

The treatment was associated with manageable toxicity, with only 26% of patients experiencing mild acute side effects like nausea, and no severe grade 3 or higher toxicities reported, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Clinical Results of MR-Guided Stereotactic Body Radiotherapy of Liver Metastases. Weykamp, F., Hoegen, P., Regnery, S., et al.[2023]

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The researchers will evaluate how well the study treatment can prevent the liver metastasis from growing and spreading. In addition, they will ...