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

Trial Summary

What is the purpose of this trial?

This is a study measuring toxicity while making observations about the survival benefits of treating participants with oligometastatic disease using stereotactic ablative radiotherapy (SABR).

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 data supports the effectiveness of the treatment Stereotactic Ablative Body Radiotherapy (SABR) for cancer?

Stereotactic Ablative Body Radiotherapy (SABR) has been shown to be effective in treating early-stage non-small-cell lung cancer (NSCLC), where it is now a standard treatment for patients who cannot undergo surgery. It has proven benefits in improving tumor control and overall survival for primary and secondary lung tumors. ^{1 2 3 4 5}

Is SABR generally safe for humans?

Stereotactic Ablative Body Radiotherapy (SABR) is generally considered safe for treating various cancers, but some serious complications have been reported. Strategies to reduce these risks are important, and studies have shown it to be a safe option for conditions like liver tumors and early-stage lung cancer. ^{2 6 7 8 9}

How is the treatment SABR different from other treatments for cancer?

Stereotactic Ablative Body Radiotherapy (SABR) is unique because it delivers very high doses of radiation precisely to a small target area in the body, often in just a few sessions, while minimizing damage to surrounding healthy tissues. This makes it particularly effective for treating small, localized tumors in various parts of the body, such as the lungs, prostate, and bones, where traditional surgery or radiation might not be suitable. ^{2 3 7 10 11}

Research Team

Robert Olson

Principal Investigator

BC Cancer Agency - Centre for the North

Eligibility Criteria

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 first chemotherapy fully eliminated the cancer that can be measured.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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 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]

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 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) 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]

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) 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 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]

References

1. England 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. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial. [2020]

3. England pubmed.ncbi.nlm.nih.gov

A systematic review of outcomes following stereotactic ablative radiotherapy in the treatment of early-stage primary lung cancer. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy (SABR) for primary and secondary lung tumours. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Long term outcome after 48 Gy stereotactic ablative body radiotherapy for peripheral stage I non-small cell lung cancer. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Pneumomediastinum as a complication of SABR for lung metastases. [2018]

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

Image-guided stereotactic ablative radiotherapy for the liver: a safe and effective treatment. [2015]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Real-World Impact of SABR on Stage I Non-Small-Cell Lung Cancer Outcomes at a Scottish Cancer Centre. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Evolution of hypofractionated accelerated radiotherapy for prostate cancer - the sunnybrook experience. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

The Role of Stereotactic Ablative Body Radiotherapy in Renal Cell Carcinoma. [2022]