SBRT for Colorectal Cancer Spread to Liver

Overseen By Aswin Abraham

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AHS Cancer Control Alberta

Disqualifiers: Extra-hepatic metastases, Past cancer, 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 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Stereotactic Body Radiation Treatment (SBRT) for colorectal cancer that has spread to the liver. The goal is to determine if SBRT can effectively target and treat liver metastases to improve patient outcomes. Suitable candidates include those with colorectal cancer who have 1-5 liver tumors, each no larger than 5 cm, and who plan to undergo surgery to remove the primary tumor. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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 prior data suggests that Stereotactic Body Radiation Treatment (SBRT) is safe for treating liver metastases from colorectal cancer?

Research has shown that Stereotactic Body Radiation Treatment (SBRT) is generally safe for treating liver tumors that have spread from colorectal cancer. Studies have found that most patients tolerate SBRT well. A review of multiple studies found that SBRT provides effective treatment results with manageable side effects. Another review noted that patients experienced only mild side effects, indicating they were not severe.

Evidence also suggests that SBRT is noninvasive and can be more effective than other treatments for larger liver tumors. These findings indicate that SBRT is a promising option with a good safety record for this type of cancer treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Stereotactic Body Radiation Treatment (SBRT) for colorectal cancer that has spread to the liver because it offers a precise and powerful approach compared to traditional radiation therapy. Unlike conventional radiation that might affect a broader area, SBRT targets tumors with high doses of radiation while sparing surrounding healthy tissue. This precision can potentially reduce treatment time and side effects, making it a promising option for patients. Additionally, SBRT can be combined with standard chemotherapy regimens like CAPOX and FOLFOX, possibly enhancing overall treatment effectiveness.

What evidence suggests that SBRT is effective for colorectal cancer spread to the liver?

Research has shown that Stereotactic Body Radiation Treatment (SBRT), which participants in this trial will receive, holds promise for treating liver tumors that have spread from colorectal cancer. Studies have found that SBRT can prevent tumor regrowth in 31% to 90% of cases after 2 years. SBRT is noninvasive and may be more effective than other methods for larger tumors. Another review found high success rates with SBRT, controlling 85% of tumors at 1 year and 75% at 2 years. This suggests that SBRT effectively controls tumors with fewer complications. ^{1 3 4 6 7}

Who Is on the Research Team?

Aswin Abraham

Principal Investigator

Cross Cancer Institute, Alberta Health Services

Are You a Good Fit for This Trial?

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.

Able and willing to comply with the terms of the protocol including health-related quality of life (HRQoL) questionnaires

Exclusion Criteria

Pregnancy

I have severe liver disease with cirrhosis.

I have had surgery or ablation for liver lesions.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Body Radiation Treatment (SBRT)

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.

How Is the Trial Designed?

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 European Union, United States, Canada for the following indications:

Approved in European Union as Stereotactic Body Radiation Therapy for:

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

Approved in United States as Stereotactic Body Radiation Therapy for:

• Colorectal cancer liver metastases
• Primary liver cancers
• Lung metastases
• Bone metastases
• Prostate cancer
• Renal cell carcinoma

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+

Published Research Related to This Trial

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) 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 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]

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 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) 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11399821/

Stereotactic body radiation therapy for colorectal cancer liver ... SBRT of metastases has reported local control rates of 31% to 90% after 2 years with tumor control correlating to biologically effective dose and motion ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1533002822001207

Stereotactic Ablative Radiation Therapy for Colorectal Liver ... SABR is an effective therapeutic option for selected patients with CRC liver metastases providing acceptable LC within the first 2 years.

3. advancesradonc.org advancesradonc.org/article/S2452-1094(23)00210-5/fulltext

Radiation Therapy for Colorectal Liver Metastasis EBRT, and specifically stereotactic body RT (SBRT), is noninvasive and may be more effective than ablation for larger lesions.

4. practicalradonc.org practicalradonc.org/article/S1879-8500(24)00272-8/abstract

Stereotactic Body Radiation therapy for Liver Metastases The review revealed pooled local control rates at 1, 2, and 3 years of 85%, 75%, and 68% respectively, while overall survival rates were 79%, 54 ...

5. redjournal.org redjournal.org/article/S0360-3016(17)33618-0/abstract

Local Control Outcomes Using Stereotactic Body Radiation ... Stereotactic body radiation therapy of liver metastases derived from colorectal cancer offers a locally effective treatment without significant complications.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1879850024002728

Stereotactic Body Radiation therapy for Liver Metastases This systematic review and meta-analysis provides a comprehensive analysis of the efficacy and safety of SBRT in treating liver metastases, and practice ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10733695/

4D-MRI assisted stereotactic body radiation therapy for ... Favorable LC rate and mild toxicities were achieved with 4D-MRI assisted SBRT. Keywords: Colorectal cancer liver metastases, 4D-MRI, ...