SBRT for Colorectal Cancer Spread to Liver

Overseen by Aswin Abraham

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: AHS Cancer Control Alberta

Disqualifiers: Extra-hepatic metastases, Past cancer, others

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Stereotactic Body Radiation Treatment (SBRT) for colorectal cancer spread to the liver?

Research shows that Stereotactic Body Radiation Therapy (SBRT) is a feasible and effective treatment for liver metastases from colorectal cancer, with studies indicating positive outcomes in local control and patient survival. ^{1 2 3 4 5}

Is SBRT safe for treating liver metastases from colorectal cancer?

Research shows that SBRT (Stereotactic Body Radiation Therapy) is generally safe for treating liver metastases from colorectal cancer, with no severe side effects reported in studies. It is important to have precise treatment planning and monitoring to ensure safety. ^{1 2 3 6 7}

How is SBRT treatment different for colorectal cancer spread to the liver?

SBRT (Stereotactic Body Radiation Therapy) is unique because it delivers high doses of radiation precisely to liver tumors from colorectal cancer, minimizing damage to surrounding healthy tissue. This makes it a viable option for patients who cannot undergo surgery, offering a targeted approach compared to conventional radiation therapy. ^{1 2 3 4 8}

Research Team

Aswin Abraham

Principal Investigator

Cross Cancer Institute, Alberta Health Services

Eligibility Criteria

This trial is for adults with colorectal cancer that has spread to the liver. They must have 1-5 liver lesions, no larger than 5cm each, and be considered for curative SBRT by a tumor board. Candidates should not have had prior surgery or ablation for liver lesions, other metastases (except certain lung ones), or a recent history of another cancer.

Inclusion Criteria

I have liver and possibly treatable lung metastases.

My liver lesion was found soon after my cancer diagnosis and may be treated with targeted radiation.

I am 18 years old or older.

Exclusion Criteria

Pregnancy

I have severe liver disease with cirrhosis.

I have had surgery or ablation for liver lesions.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neo-adjuvant Treatment

Participants receive a short course of radiation followed by 6-9 cycles of chemotherapy as per NCCN guidelines

2-3 months

Re-staging

Participants are re-staged to assess response to neo-adjuvant treatment

1-2 weeks

SBRT Treatment

Participants receive Stereotactic Body Radiation Therapy (SBRT) to the metastatic liver and possibly lung lesions

1-2 weeks

Surgery

Surgery for the primary rectal cancer is performed

1 week

Follow-up

Participants are monitored for safety, effectiveness, and quality of life after treatment

24 months

Treatment Details

Interventions

• Stereotactic Body Radiation Treatment (SBRT) (Radiation Therapy)

Trial Overview The study is testing the use of stereotactic body radiation treatment (SBRT) on patients with colorectal cancer who have specific types of liver metastases. The goal is to see if this targeted radiation therapy can effectively treat these metastases after initial chemotherapy.

Participant Groups

Group I: SBRT to the metastatic liver +/- lung lesions Experimental Treatment 1 Intervention

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.

Stereotactic Body Radiation Treatment (SBRT) is already approved in Canada for the following indications:

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Colorectal cancer liver metastases
• Primary liver cancers
• Lung metastases
• Bone metastases

Who Is Running the Clinical Trial?

AHS Cancer Control Alberta

Lead Sponsor

Trials

188

Recruited

26,900+

Dr. Peter Jamieson

AHS Cancer Control Alberta

Chief Medical Officer since 2024

MD from the University of Alberta

Andre Tremblay

AHS Cancer Control Alberta

Chief Executive Officer

BA in Political Science from the University of Victoria, MA in Political Science from the University of British Columbia

Findings from Research

Stereotactic body radiation therapy (SBRT) effectively treated 15 inoperable liver metastases in 11 patients, achieving 100% local control at 2 months and maintaining 50% at 12 months, indicating strong initial effectiveness.

The treatment was well-tolerated with no severe side effects reported, suggesting that SBRT is a safe option for patients with limited treatment alternatives for colorectal cancer liver metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for colorectal cancer liver metastases; early results. Burkon, P., Slampa, P., Kazda, T., et al.[2013]

Stereotactic body radiation therapy (SBRT) demonstrated a 74% local control rate and an 83% survival rate over two years in 20 patients with colorectal liver metastases who were not eligible for surgery or radiofrequency ablation.

The treatment was generally well-tolerated, with most patients experiencing low-grade toxicity, although two patients did experience more severe hepatic toxicity (grade 3).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for colorectal liver metastases. van der Pool, AE., Méndez Romero, A., Wunderink, W., et al.[2022]

Stereotactic body radiation therapy (SBRT) is a safe and effective treatment for patients with limited hepatic metastases from colorectal cancer, showing a 72% local control rate at one year and a median survival of 16.1 months based on a study of 11 patients.

The treatment resulted in manageable side effects, with most patients experiencing only mild to moderate toxicities, indicating that SBRT could be a viable option for patients who may not be candidates for surgery or conventional radiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for liver metastases from colorectal cancer: analysis of safety, feasibility, and early outcomes. Kress, MS., Collins, BT., Collins, SP., et al.[2022]

Stereotactic body radiation therapy (SBRT) was found to be a feasible and effective treatment for 42 patients with inoperable colorectal liver metastases, achieving a 91% local control rate at 24 months.

Patients treated with SBRT had a median overall survival of 29.2 months and experienced minimal toxicity, with no cases of radiation-induced liver disease or severe side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Final results of a phase II trial for stereotactic body radiation therapy for patients with inoperable liver metastases from colorectal cancer. Scorsetti, M., Comito, T., Tozzi, A., et al.[2022]

Stereotactic body radiation therapy (SBRT) demonstrated high local control rates for liver metastases, with 1-year and 2-year local control rates of 82% and 76.2%, respectively, based on a study of 24 patients over a median follow-up of 22 months.

The treatment also showed promising overall survival rates, with a median overall survival of 35 months and 1-year and 2-year survival rates of 85.83% and 68%, respectively, while exhibiting no significant toxicity (grade 3 or 4) during the follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for liver metastases: Clinical outcomes and literature review. de la Peña, C., Gonzalez, MF., González, C., et al.[2022]

Stereotactic body radiation therapy (SBRT) demonstrated a 1-year local control rate of 70.2% and an overall survival rate of 89.0% in a study of 48 patients with oligometastases from colorectal cancer, indicating its effectiveness in managing this condition.

The treatment was found to be safe, with no patients experiencing acute toxicities of grade 3 or above, suggesting that SBRT can be administered with a favorable safety profile when combined with precise motion management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Stereotactic body radiation therapy for patients with lung and liver oligometastases from colorectal cancer: a phase Ⅱ trial]. Lei, JQ., Liu, WY., Tang, Y., et al.[2022]

Robotic stereotactic radiotherapy (SBRT) for liver oligometastatic colorectal cancer showed a clinical benefit rate of 71.4% and a median overall survival of 67.3% at one year, indicating its efficacy in treating this condition.

The presence of extrahepatic disease significantly worsened progression-free survival and overall survival, highlighting the importance of patient selection for optimal treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic stereotactic radiotherapy for liver oligometastases from colorectal cancer: a single-center experience. Vernaleone, M., Bonomo, P., Di Cataldo, V., et al.[2020]

Stereotactic body radiotherapy (SBRT) demonstrated a median overall survival of 20.4 months and a median local control of 35.1 months in a study of 115 patients with liver metastases, indicating its effectiveness as a treatment option.

While 70.4% of patients experienced acute toxicities, mostly mild to moderate, SBRT is still considered a well-tolerated and promising therapy for hepatic metastases, suggesting it can be integrated into treatment plans for patients with oligometastatic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of using high-precision radiotherapy in the treatment of liver metastases regarding toxicity and survival. Voglhuber, T., Eitz, KA., Oechsner, M., et al.[2021]

References

1. Czech Republic pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for colorectal cancer liver metastases; early results. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for colorectal liver metastases. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for liver metastases from colorectal cancer: analysis of safety, feasibility, and early outcomes. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Final results of a phase II trial for stereotactic body radiation therapy for patients with inoperable liver metastases from colorectal cancer. [2022]

5. Poland pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for liver metastases: Clinical outcomes and literature review. [2022]

6. China pubmed.ncbi.nlm.nih.gov

[Stereotactic body radiation therapy for patients with lung and liver oligometastases from colorectal cancer: a phase Ⅱ trial]. [2022]

7. Italy pubmed.ncbi.nlm.nih.gov

Robotic stereotactic radiotherapy for liver oligometastases from colorectal cancer: a single-center experience. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Analysis of using high-precision radiotherapy in the treatment of liver metastases regarding toxicity and survival. [2021]