SABR for Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: British Columbia Cancer Agency

Must not be taking: Chemotherapy agents

Disqualifiers: Serious comorbidities, Brain metastasis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Varies based on individual treatment plan

399 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a type of targeted radiation therapy called stereotactic ablative radiotherapy (SABR) to determine its effectiveness for a specific type of cancer that has spread but not extensively (oligometastatic disease). Researchers aim to discover if SABR can reduce side effects and improve survival rates. Individuals with cancer that has spread to no more than five areas and cannot be treated with surgery might be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future cancer treatments.

Will I have to stop taking my current medications?

The trial requires that you stop taking chemotherapy agents starting 2 weeks before radiation and until 1 week after the last treatment. However, hormonal therapy is allowed during the trial.

What prior data suggests that stereotactic ablative radiotherapy (SABR) is safe for treating oligometastatic disease?

Research has shown that stereotactic ablative body radiotherapy (SABR) is generally easy for patients to handle. Studies have found it remains safe even in the long term. For example, one study reported that no patients experienced severe harmful side effects after treatment. Another study noted that SABR has been safely used in the U.S. since 2003 for patients unable to undergo lung surgery. These findings suggest that SABR is a safe option for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Stereotactic Ablative Body Radiotherapy (SABR) is unique because it delivers highly focused radiation beams to cancerous tumors with extreme precision, which limits damage to surrounding healthy tissue. Unlike traditional radiation therapy that often requires multiple sessions over several weeks, SABR can achieve similar or better results in just a few treatments. Researchers are excited about SABR because it has the potential to improve patient outcomes by reducing treatment time and minimizing side effects, making it a promising option for cancer patients.

What evidence suggests that SABR is effective for treating oligometastatic disease?

Research has shown that stereotactic ablative body radiotherapy (SABR), which participants in this trial will receive, can effectively treat certain cancers. One study found that SABR successfully stopped cancer growth in the treated area 94.7% of the time. Another study reported good long-term survival rates for patients with kidney cancer treated with SABR. SABR also offers a safe, non-invasive option for patients with certain types of cancer that have spread, such as breast cancer. Additionally, SABR has low side effects, making it a safer choice for many patients. These findings suggest that SABR could help treat cancers that have spread to a few areas, known as oligometastatic disease. ^{1 4 6 7 8}

Who Is on the Research Team?

Robert Olson

Principal Investigator

BC Cancer Agency - Centre for the North

Are You a Good Fit for This Trial?

This trial is for people with a limited number of cancer spread sites (up to 5), who've had their primary tumor treated, and are not candidates for surgery. They should be in relatively good health otherwise, able to consent, and complete questionnaires in English. Pregnant women or those with certain medical conditions that make radiotherapy unsafe cannot join.

Inclusion Criteria

I can take care of myself and am up and about more than half of the day.

My brain metastases have been approved for treatment by a specialized team.

I only need a PET-CT or PSMA-PET scan for certain conditions.

Exclusion Criteria

Pregnant or lactating women

I have signs of pressure on my spinal cord.

My cancer cannot be treated with the goal of removing it completely.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive stereotactic ablative radiotherapy (SABR) to all sites of metastatic disease

Varies based on individual treatment plan

Multiple visits for radiotherapy sessions

Follow-up

Participants are monitored for toxicity, quality of life, and survival outcomes post SABR treatment

Up to 5 years

Regular follow-up visits as per study protocol

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Ablative Body Radiotherapy (SABR)

Trial Overview The study tests Stereotactic Ablative Body Radiotherapy (SABR) on patients with few metastatic cancer sites. It aims to assess the side effects and potential survival benefits of this targeted high-dose radiation therapy compared to other treatments.

How Is the Trial Designed?

Group I: Stereotactic arm Experimental Treatment 1 Intervention

Stereotactic ablative radiotherapy

Who Is Running the Clinical Trial?

British Columbia Cancer Agency

Lead Sponsor

Trials

181

Recruited

95,900+

Published Research Related to This Trial

In a multicenter phase 3 trial involving 101 patients with inoperable stage 1 non-small-cell lung cancer, stereotactic ablative body radiotherapy (SABR) demonstrated significantly better local control compared to standard radiotherapy, with a 68% reduction in the risk of local treatment failure (hazard ratio 0.32).

SABR was associated with a similar safety profile to standard radiotherapy, showing no increase in major toxicity, making it a preferred treatment option for patients with this type of lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy versus standard radiotherapy in stage 1 non-small-cell lung cancer (TROG 09.02 CHISEL): a phase 3, open-label, randomised controlled trial. Ball, D., Mai, GT., Vinod, S., et al.[2022]

In a study of 300 patients with stage I non-small cell lung cancer treated with stereotactic ablative body radiotherapy (SABR), the treatment showed promising long-term local control and survival rates, with overall survival rates of 83% at 1 year and 37% at 4 years.

The treatment was associated with low toxicity, as no severe grade 4 or 5 adverse effects were reported, indicating that SABR is a safe and effective option for patients with this type of lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long term outcome after 48 Gy stereotactic ablative body radiotherapy for peripheral stage I non-small cell lung cancer. Dubaere, E., Goffaux, M., Wanet, M., et al.[2020]

Stereotactic ablative body radiotherapy (SABR) is a feasible and well-tolerated treatment for patients with bone-only oligometastatic breast cancer, with 80% of patients successfully receiving treatment and no severe (grade 3 or 4) toxicities reported.

The treatment showed promising efficacy, with a 100% local progression-free survival (LPFS) and 67% distant progression-free survival (DPFS) at two years, suggesting that SABR could be a viable option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial. David, S., Tan, J., Savas, P., et al.[2020]

Stereotactic ablative body radiotherapy (SABR) has shown a local control rate of over 90% in treating primary renal cell carcinoma (RCC) across 589 cases, with low rates of severe toxicity (grade 3-4) ranging from 0-9%.

In patients with oligometastatic RCC, SABR can delay the need for systemic therapy for at least one year in 70-90% of cases, indicating its effectiveness as a treatment option and its compatibility with systemic therapies like targeted therapy or immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Stereotactic Ablative Body Radiotherapy in Renal Cell Carcinoma. Ali, M., Mooi, J., Lawrentschuk, N., et al.[2022]

The introduction of stereotactic ablative body radiotherapy (SABR) for stage I non-small-cell lung cancer (NSCLC) at a Scottish cancer center has led to improved median survival rates, increasing from 32.5 months before SABR was available to 48.8 months after its establishment.

SABR has not only improved survival outcomes but also increased the proportion of patients receiving radical therapy, particularly among younger and healthier patients, indicating its effectiveness as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Impact of SABR on Stage I Non-Small-Cell Lung Cancer Outcomes at a Scottish Cancer Centre. Stares, M., Lewis, G., Vallet, M., et al.[2023]

Stereotactic ablative body radiotherapy (SABR) demonstrated a high efficacy in treating inoperable liver tumors, with 72.7% of patients showing partial regression and 27.3% achieving complete remission three months post-treatment.

The treatment was well-tolerated, with no severe toxicity (grade 2 or higher) reported, and resulted in one- and two-year overall survival rates of 85.4% and 68.8%, respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided stereotactic ablative radiotherapy for the liver: a safe and effective treatment. Van De Voorde, L., Vanneste, B., Houben, R., et al.[2015]

Stereotactic ablative body radiotherapy (SABR) is now the standard treatment for early-stage non-small-cell lung cancer (NSCLC) in patients who cannot undergo surgery, highlighting its efficacy in this patient population.

The review also discusses the safety profile of SABR, including reported toxicity rates, and explores its potential use in combination with other therapies for improved outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of outcomes following stereotactic ablative radiotherapy in the treatment of early-stage primary lung cancer. Murray, P., Franks, K., Hanna, GG.[2022]

Stereotactic ablative body radiotherapy (SABR) is an advanced treatment that delivers high doses of radiation in fewer sessions while protecting surrounding healthy tissues, making it effective for small tumors in various locations, including the prostate.

SABR is becoming a standard treatment for low and intermediate-risk prostate cancer, supported by research from Sunnybrook and the US prostate SABR consortium, highlighting its efficacy in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution of hypofractionated accelerated radiotherapy for prostate cancer - the sunnybrook experience. Musunuru, HB., Cheung, P., Loblaw, A.[2022]

Stereotactic ablative radiotherapy (SABR) has rapidly expanded in clinical use for treating various primary and metastatic tumors, demonstrating promising results in tumor control.

Despite its effectiveness, SABR can lead to serious complications, highlighting the need for strategies to reduce these risks and improve the safety of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. Lo, SS., Sahgal, A., Chang, EL., et al.[2018]

Stereotactic ablative body radiotherapy (SABR) is a significant advancement in radiotherapy that has been shown to improve tumor control and overall survival in patients with lung tumors.

The review highlights the current evidence supporting the efficacy of SABR for both primary and secondary lung tumors, along with ongoing trials that may further validate its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy (SABR) for primary and secondary lung tumours. Goldsmith, C., Gaya, A.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5601509/

A systematic review of outcomes following stereotactic ... Although not statistically significant, the 3- and 5- year survival rates for the patients who received SABR plus adjuvant chemotherapy were 80.5% and 46%, ...

2. oncodaily.com oncodaily.com/oncolibrary/radiotherapy/stereotactic-radiotherapy-success

Success Rate and Survival After Stereotactic Radiotherapy Estimated 1-year outcomes included a high local control rate of 94.7%, overall survival of 85.4%, and progression-free survival of 51.4%. The ...

3. thelancet.com thelancet.com/journals/lanonc/article/PIIS1470-2045(22)00656-8/abstract

5-year outcomes after stereotactic ablative body ... SABR is effective and safe in the long term for patients with primary renal cell carcinoma. Single-fraction SABR might yield less local failure ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0936655524001092

Treatment Outcomes of Stereotactic Ablative Body ... This study confirmed that SABR was a safe, non-invasive treatment option for patients with extracranial OM and OP diseases originated from primary breast cancer ...

5. jto.org jto.org/article/S1556-0864(24)00763-9/fulltext

Historical Versus Modern Data of Stereotactic Ablative ... The results support the utilization of SABR for these patients (with a 90-day toxicity rate of 3.8% and a 90-day all-cause mortality of 1.7%), but more ...

6. redjournal.org redjournal.org/article/S0360-3016(25)06209-1/abstract

5-year survival and safety of stereotactic ablative ... The 3-, 5-year OS rates were 70 ± 6%, 46 ± 7%. No patients developed ≥G3 late toxicities. The 3-, 5-year LR-FS rates were 64 ± 7%, 64 ± 7%, ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301623003255

Safety and Efficacy Results From iSABR, a Phase 1 Study ... In 2003, lung SABR for medically inoperable patients was first studied in the United States by Timmerman and colleagues with excellent safety and efficacy.

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

Safety and Survival Rates Associated With Ablative ... The estimate for 1-year overall survival was 85.4% (95% CI, 77.1%-92.0%; I2 = 82%; 95% CI, 71%-88%; and τ = 0.72%; 95% CI, 0.30%-2.09%) and 51.4 ...