SABR for Metastatic Cancer

Overseen By David Palma, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Must be taking: Hormone therapy

Must not be taking: Cytotoxic agents

Disqualifiers: Interstitial lung disease, Crohn's, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new radiation treatment called SABR (Stereotactic Ablative Radiotherapy), which targets small cancer areas with high-dose, precise radiation. The goal is to determine if SABR is safe and effective for individuals with poly-metastatic cancer, where cancer has spread to more than 10 sites in the body. Potential candidates include those with more than 10 cancer sites who have no available or desired standard treatment options. As an unphased trial, this study provides patients the opportunity to explore innovative treatment options when standard treatments are unsuitable.

Will I have to stop taking my current medications?

You may need to stop taking certain medications. Cytotoxic, immunotherapeutic, or molecularly targeted agents are not allowed starting 2 weeks before radiation. However, you can continue hormone therapies like anti-estrogen or anti-testosterone treatments.

What prior data suggests that this technique is safe for treating poly-metastatic cancer?

Research has shown that stereotactic ablative radiotherapy (SABR) is generally safe and well-tolerated for patients with a small number of cancer sites. Studies have demonstrated that SABR can be safely used in certain cases where cancer has spread to a few areas. One study found SABR to be safe and feasible for treating patients with multiple cancer sites, although this is still under investigation.

SABR delivers high doses of radiation directly to cancer cells, potentially reducing side effects by limiting radiation exposure to the rest of the body. While SABR is already a standard treatment for some lung and brain cancers, ongoing research examines its safety in patients with more widespread cancer. Overall, current evidence suggests it is well-tolerated, but studies continue to ensure its safety in broader applications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Stereotactic ablative radiotherapy (SABR) is unique because it delivers highly focused radiation to cancer cells with extreme precision, minimizing damage to surrounding healthy tissue. Unlike traditional radiation therapy, which often involves multiple sessions over several weeks, SABR can achieve similar or better results in just a few sessions. Researchers are excited about SABR because it has the potential to improve patient outcomes, reduce treatment times, and offer a less invasive option for managing metastatic cancer.

What evidence suggests that SABR could be an effective treatment for poly-metastatic cancer?

Research has shown that Stereotactic Ablative Radiotherapy (SABR) can be effective for certain cancers. One study found that SABR helped patients live 22 months longer compared to those who did not receive it. Another study reported that 82.6% of patients were still alive one year after receiving SABR. Some patients even experienced a reduction or disappearance of their cancer, with 5.8% achieving a complete response and 25.5% achieving a partial response. These findings suggest that SABR could be a promising treatment option, especially for cancers that haven't spread much. This trial will explore different dose levels of SABR, including De-escalation Level and Dose Levels 1 through 4, to determine the most effective approach for metastatic cancer. ^{3 5 6 7 8}

Who Is on the Research Team?

Glenn Bauman, MD

Principal Investigator

London Health Sciences Centre, Lawson Health Research Institute

Are You a Good Fit for This Trial?

This trial is for adults with poly-metastatic cancer, meaning they have more than 10 sites of cancer in their body. They should not be pregnant or breastfeeding, must have a life expectancy over 3 months, and cannot start new systemic therapies within 6 weeks after radiotherapy. Patients with severe liver or kidney dysfunction, large brain metastases, or certain medical conditions that preclude radiotherapy are excluded.

Inclusion Criteria

My cancer has spread, and this was confirmed by tests.

Spine: MRI of the spine is not mandatory for enrollment.

My doctor believes all my cancer sites can be safely treated.

Exclusion Criteria

I have signs of pressure on my spinal cord.

My cancer has spread to the brainstem.

My liver is not working well due to cancer spread.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive stereotactic ablative radiotherapy (SABR) to treat poly-metastatic disease

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years and 3 months

Long-term follow-up

Participants are monitored for progression-free survival post radiotherapy

4 years

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic ablative radiotherapy - De-escalation Level
• Stereotactic ablative radiotherapy - Level 1
• Stereotactic ablative radiotherapy - Level 2
• Stereotactic ablative radiotherapy - Level 3
• Stereotactic ablative radiotherapy - Level 4

Trial Overview The ARREST study tests the safety of Stereotactic Ablative Radiotherapy (SABR) on patients with poly-metastatic disease. SABR delivers high-dose radiation precisely to small areas and may reduce side effects by limiting exposure to healthy tissue. This phase I trial will determine if it's safe for those who have widespread cancer beyond what's currently treated with SABR.

How Is the Trial Designed?

Group I: Dose Level 4 Experimental Treatment 1 Intervention

Group II: Dose Level 3 Experimental Treatment 1 Intervention

Group III: Dose Level 2 Experimental Treatment 1 Intervention

Group IV: Dose Level 1 Experimental Treatment 1 Intervention

Group V: De-escalation Level Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Ontario Institute for Cancer Research

Collaborator

Trials

24

Recruited

9,200+

Published Research Related to This Trial

Stereotactic ablative radiation therapy (SABR) was found to be effective for treating pulmonary metastases, with a median follow-up of 23 months showing improved overall survival (OS) for patients with 3 or fewer metastases compared to those with more (74.2% vs. 59.3% at 24 months).

Patients with less responsive primary tumors (like adrenal or pancreatic cancers) had higher local failure rates, suggesting that higher doses of SABR or surgical options may be necessary for these cases to improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiation therapy for pulmonary metastases: Improving overall survival and identifying subgroups at high risk of local failure. Pasalic, D., Lu, Y., Betancourt-Cuellar, SL., et al.[2021]

Stereotactic ablative radiotherapy (SABR) demonstrated a high local control rate of 91.2% for skeletal metastases in a study of 22 patients, with a median follow-up of 15.6 months, indicating its effectiveness in managing oligometastatic and oligoprogressive diseases.

The treatment resulted in significant pain control for two-thirds of symptomatic patients, with limited toxicities reported, including only two vertebral fractures and one case of grade 3 esophagitis, suggesting that SABR is a safe option for patients with skeletal metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of stereotactic ablative radiotherapy in oligometastatic & oligoprogressive skeletal metastases: Results and pattern of failure. Kam, TY., Chan, OSH., Hung, AWM., et al.[2019]

In a phase II trial involving 106 patients with metastatic cancers, the combination of ipilimumab and stereotactic ablative radiotherapy (SABR) showed promising long-term survival rates, with 5-year overall survival rates of 15%.

Patients receiving SABR targeting lung metastases had significantly better overall survival (18.67 months) and progression-free survival (6.87 months) compared to those with liver metastases, highlighting the importance of tumor location in treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year overall survival with ipilimumab and stereotactic ablative radiotherapy for metastatic disease. He, K., Hong, DS., Tang, C., et al.[2023]

Stereotactic ablative radiotherapy (SABR) shows high effectiveness for oligometastatic breast cancer, achieving local control rates of 97% at 1 year and 90% at 2 years, based on a meta-analysis of 10 studies involving 467 patients.

SABR is associated with a low toxicity rate, with only 4.1% of patients experiencing grade 2 or 3 side effects, indicating it is a safe treatment option for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy to treat breast cancer oligometastases: A systematic review with meta-analysis. Viani, GA., Gouveia, AG., Louie, AV., et al.[2021]

A consensus document was created by trial management groups from six UK studies on stereotactic ablative radiotherapy (SABR) to establish updated organ at risk dose constraints, enhancing safety during treatment.

This unified approach aims to standardize the implementation of SABR across the UK, enabling better comparisons of toxicity and efficacy between different SABR studies both nationally and internationally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

UK Consensus on Normal Tissue Dose Constraints for Stereotactic Radiotherapy. Hanna, GG., Murray, L., Patel, R., et al.[2022]

Stereotactic ablative radiotherapy (SABR) using Cyberknife demonstrated high effectiveness in treating stage I non-small-cell lung cancer, with 2-year local control, progression-free, and overall survival rates of 91.9%, 61.7%, and 84.8%, respectively, based on a study of 153 patients.

The treatment was generally safe, with only 8.1% of patients experiencing severe toxicities, including one case of grade 5 radiation pneumonitis, indicating that while SABR is effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. Hayashi, K., Suzuki, O., Shiomi, H., et al.[2022]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK603676/

Stereotactic Ablative Radiotherapy for the Treatment of ... - NCBI The current clinical evidence suggests that SABR plus SOC may offer survival benefits for patients with oligometastatic cancer compared to SOC alone. However, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S016781402500043X

1-year efficacy results after MR-guided risk-adapted ... We achieved a high one-year overall survival rate of 82.6% using MR-guided SABR. •. Half of the patients remained off systemic therapy during 1-year follow-up.

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.20.00818

Long-Term Results of the SABR-COMET Phase II ... In this long-term report from an international randomized phase II trial, patients who received SABR demonstrated a 22-month improvement in median OS.

4. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2763312

Outcomes of Observation vs Stereotactic Ablative ... Two trials5,6 have shown that stereotactic ablative radiotherapy (SABR) significantly improves progression-free survival (PFS) and overall ...

5. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-023-02286-5

Comparison of outcome after stereotactic ablative ... Response and survival data. Overall, 8 (5.8%) patients had a complete response after SABR, 35 (25.5%) had a partial response, 55 (40.1%) had ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7689573/

Safety and Survival Rates Associated With Ablative ... The findings of this study suggest that stereotactic ablative radiotherapy is generally safe and well tolerated in the oligometastatic setting.

7. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2773455

Safety and Survival Rates Associated With Ablative ... The findings of this study suggest that stereotactic ablative radiotherapy is generally safe and well tolerated in the oligometastatic setting.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301624025410

A Phase 1 Study of Stereotactic Ablative Radiation Therapy ... The ARREST study demonstrated that SABR treatment for all sites of polymetastatic disease is safe and feasible in selected patients.