SABR for Oligometastatic Cancer

(SABR-COMET-3 Trial)

Not currently recruiting at 19 trial locations

Overseen By Hadassah Abraham, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: British Columbia Cancer Agency

Must not be taking: Chemotherapy agents

Disqualifiers: Concurrent cancer, Poor lung function, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Stereotactic Ablative Radiotherapy (SABR), a precise, high-dose radiation treatment, can improve outcomes for people with oligometastatic cancer, characterized by 1-3 current cancer spread spots. The study compares SABR with standard care options to determine if it extends life, slows cancer progression, and enhances quality of life. Suitable participants have a stable primary tumor and up to three current spread spots, and cannot undergo surgery to remove all cancer sites. The trial also examines the cost-effectiveness of SABR and aims to identify markers that predict who benefits most. As an unphased trial, it offers patients the 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 (drugs used to kill cancer cells) starting 2 weeks before radiation and until 1 week after the last treatment if you are in the SABR group.

What prior data suggests that Stereotactic Ablative Radiotherapy (SABR) is safe for treating oligometastatic cancer?

Research has shown that Stereotactic Ablative Radiotherapy (SABR) is generally safe and well-tolerated for treating oligometastatic cancer. Studies have found that patients usually experience only minor side effects. SABR delivers precise radiation directly to the tumor, sparing the surrounding healthy tissue. This accuracy reduces the chance of unwanted effects, making it a promising treatment option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Stereotactic Ablative Radiotherapy (SABR) is unique because it delivers high doses of radiation precisely to cancer cells, minimizing damage to surrounding healthy tissue. This precision makes it different from standard palliative radiotherapy, which often affects a broader area and can lead to more side effects. Researchers are excited about SABR because it has the potential to improve outcomes for patients with oligometastatic cancer by targeting tumors more effectively and potentially enhancing the benefits of chemotherapy.

What evidence suggests that SABR could be an effective treatment for oligometastatic cancer?

Research has shown that Stereotactic Ablative Radiotherapy (SABR) may benefit patients with oligometastatic cancer. In this trial, participants will be assigned to different treatment arms. The Stereotactic Arm (Arm 2) will receive SABR alongside chemotherapy, while the Standard of Care Treatment (Arm 1) will involve standard care, including palliative radiotherapy and chemotherapy. Studies suggest that SABR, when combined with standard care, might extend patients' lives compared to standard care alone. For instance, one study found that SABR had a high success rate of 89% in controlling cancer in the abdomen for at least one year. SABR is also considered a safe and effective way to treat patients with a small number of cancer spread areas. Overall, SABR seems to offer significant benefits in managing oligometastatic cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Robert Olson

Principal Investigator

BC Cancer Prince George

Are You a Good Fit for This Trial?

This trial is for adults with a limited number of cancer metastases (1-3 currently, up to 8 in their lifetime). They must have controlled primary tumors, be able to hold still during treatment, and not be pregnant. Excluded are those with concurrent cancers within the last 5 years, certain organ dysfunctions or large brain metastases.

Inclusion Criteria

I've had a brain scan within the last 8 weeks to check for cancer spread.

My primary cancer is under control.

I've had a physical exam and my activity level checked within the last 6 weeks.

Exclusion Criteria

I need surgery to fix a bone in my thigh.

I have or had a tumor close to my spinal cord, but if removed, it's part of my 8 lifetime metastases limit.

Pregnant or breastfeeding women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard of care palliative radiotherapy or stereotactic ablative radiotherapy (SABR) based on randomization

2 weeks

Multiple visits for radiotherapy sessions

Follow-up

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

5 years

Visits at 3 months, 6 months, and every 6 months for the first 2 years, then annually

Extension/Long-term follow-up

Participants may continue to be monitored for overall survival and progression-free survival

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Palliative Radiotherapy
• Stereotactic Ablative Radiotherapy

Trial Overview The study compares Stereotactic Ablative Radiotherapy (SABR), a high-dose radiation therapy targeting small tumor areas non-invasively on an outpatient basis, against standard palliative care. It will assess survival rates, side effects, quality of life and cost-effectiveness.

How Is the Trial Designed?

Group I: Stereotactic Arm (Arm 2) Experimental Treatment 1 Intervention

Stereotactic ablative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist

Group II: Standard of Care Treatment (Arm 1) Active Control 1 Intervention

Standard of care, palliative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist

Stereotactic Ablative Radiotherapy is already approved in European Union, United States, United Kingdom for the following indications:

Approved in European Union as Stereotactic Ablative Radiotherapy for:

• Early-stage non-small cell lung cancer
• Liver cancers
• Kidney cancers
• Bone metastasis
• Spinal metastasis
• Prostate cancers

Approved in United States as Stereotactic Ablative Radiotherapy for:

• Early-stage non-small cell lung cancer
• Liver cancers
• Kidney cancers
• Bone metastasis
• Spinal metastasis
• Prostate cancers

Approved in United Kingdom as Stereotactic Ablative Radiotherapy for:

• Early-stage non-small cell lung cancer
• Liver cancers
• Kidney cancers
• Bone metastasis
• Spinal metastasis
• Prostate cancers

Who Is Running the Clinical Trial?

British Columbia Cancer Agency

Lead Sponsor

Trials

181

Recruited

95,900+

Bon Secours Cork Cancer Centre

Collaborator

Trials

1

Recruited

330+

Walker Family Cancer Centre

Collaborator

Trials

1

Recruited

330+

Cancer Research UK Edinburgh Centre

Collaborator

Trials

2

Recruited

550+

UPMC Hillman Cancer Centre

Collaborator

Trials

1

Recruited

330+

Beatson West of Scotland Cancer Centre

Collaborator

Trials

3

Recruited

1,200+

Tom Baker Cancer Centre

Collaborator

Trials

30

Recruited

8,900+

Riverina Cancer Care Centre

Collaborator

Trials

1

Recruited

330+

Aberdeen Royal Infirmary

Collaborator

Trials

11

Recruited

41,300+

London Regional Cancer Program, Canada

Collaborator

Trials

11

Recruited

1,300+

Published Research Related to This Trial

Stereotactic body radiation therapy (SBRT) is recommended as a safe and effective treatment for patients with oligometastatic non-small cell lung cancer, particularly when there are 3 or fewer metastatic deposits, based on a review of literature from 2008 to 2020.

The American Radium Society Lung Cancer Panel advises that consolidative radiation therapy should follow first-line systemic therapy rather than being administered upfront, and emphasizes the importance of individualized treatment plans due to limited data on certain clinical scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

American Radium Society Appropriate Use Criteria for Radiation Therapy in Oligometastatic or Oligoprogressive Non-Small Cell Lung Cancer. Amini, A., Verma, V., Simone, CB., et al.[2022]

The TROG 13.01/ALTG 13.001 clinical trial is investigating the safety and efficacy of single versus multi-fraction stereotactic ablative body radiotherapy (SABR) for lung tumors in 84 patients with up to three metastases, aiming to determine the best treatment approach for pulmonary oligometastases.

The study will compare a single high dose of 28Gy to a total of 48Gy delivered in four fractions, assessing not only safety but also quality of life, survival rates, and potential cost implications of each treatment method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised phase II trial of Stereotactic Ablative Fractionated radiotherapy versus Radiosurgery for Oligometastatic Neoplasia to the lung (TROG 13.01 SAFRON II). Siva, S., Kron, T., Bressel, M., et al.[2022]

Stereotactic ablative radiation therapy (SABR) for lung oligometastases shows promising safety and efficacy, with a 24-month overall survival rate of 74.6% and minimal toxicity, as only one significant adverse event was reported among 77 patients studied over an average follow-up of 22 months.

Colorectal metastases exhibited a notably higher local failure rate compared to other types of tumors, suggesting they may be more resistant to SABR, indicating a need for potential dose escalation strategies for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colorectal Histology Is Associated With an Increased Risk of Local Failure in Lung Metastases Treated With Stereotactic Ablative Radiation Therapy. Binkley, MS., Trakul, N., Jacobs, LR., 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]

In a study of 132 patients treated with single fraction stereotactic ablative body radiotherapy (SABR) for oligometastases, there was a 75% rate of freedom from widespread disease at 1 year, indicating effective disease control.

The treatment showed a high local control rate of 90% at 1 year and low toxicity, with only one case of significant treatment-related side effects, suggesting that single fraction SABR is a safe and effective option compared to traditional multi-fraction approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single Fraction Stereotactic Ablative Body Radiotherapy for Oligometastasis: Outcomes from 132 Consecutive Patients. Gandhidasan, S., Ball, D., Kron, T., et al.[2019]

A 68-year-old woman treated with stereotactic body radiation therapy (SBRT) for lung metastases experienced pathological vertebral fractures ten months post-treatment, highlighting a previously unreported adverse effect of SBRT.

Despite achieving a complete response of the metastatic disease without signs of radiation pneumonitis, the case emphasizes the need for oncologists to consider the risk of bone toxicity, particularly in older patients with potential low bone mineral density (BMD).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathological vertebral fracture after stereotactic body radiation therapy for lung metastases. Case report and literature review. Rodríguez-Ruiz, ME., San Miguel, I., Gil-Bazo, I., et al.[2022]

Stereotactic ablative radiotherapy (SABR) is a highly effective and low-toxicity treatment for metastatic tumors, achieving local control rates of about 80%.

SABR shows promise in treating oligometastatic patients, with pilot studies suggesting it may be 'curative' in 20-25% of cases, especially when combined with systemic therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New concepts and insights into the role of radiation therapy in extracranial metastatic disease. Ricardi, U., Filippi, AR., Franco, P.[2013]

A single session of stereotactic ablative body radiotherapy (SABR) for oligometastatic prostate cancer was found to be feasible and safe, with only one significant adverse event (a vertebral fracture) reported among 33 patients over a 2-year follow-up period.

The treatment resulted in high local progression-free survival rates of 97% at 1 year and 93% at 2 years, with nearly half of the patients (48%) avoiding the need for androgen deprivation therapy at the 2-year mark, indicating effective disease control and maintained quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Abative Body Radiotherapy (SABR) for Oligometastatic Prostate Cancer: A Prospective Clinical Trial. Siva, S., Bressel, M., Murphy, DG., et al.[2022]

In a study of 381 patients treated with stereotactic ablative body radiotherapy (SABR) for oligometastatic disease, the incidence of grade 3 or higher toxic effects was found to be less than 5%, indicating a favorable safety profile.

The rates of grade 2 or higher toxic effects were 18.6%, which is lower than the previously reported 29% in the SABR-COMET trial, suggesting that SABR may have acceptable toxicity levels and supports further research in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment With Stereotactic Ablative Radiotherapy for Up to 5 Oligometastases in Patients With Cancer: Primary Toxic Effect Results of the Nonrandomized Phase 2 SABR-5 Clinical Trial. Olson, R., Jiang, W., Liu, M., et al.[2023]

In a study of 39 patients with 45 lung lesions treated with stereotactic ablative body radiotherapy (SBRT), local progression-free survival rates were high, with 90.5% at 1 year and 80.5% at 2 years, indicating effective tumor control.

The treatment was well-tolerated with only mild acute side effects, suggesting that the moderate dose schedules of 35 Gy (5 fractions) or 37.5 Gy (3 fractions) are safe and effective for managing non-small cell lung cancer and metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy for small lung tumors with a moderate dose. Favorable results and low toxicity. Duncker-Rohr, V., Nestle, U., Momm, F., 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. ascopubs.org ascopubs.org/doi/10.1200/GO.23.00275

Stereotactic Ablative Radiotherapy in Oligometastatic ... Stereotactic ablative body radiotherapy (SABR) comes to the fore as a safe and effective treatment for patients with a limited number of metastases.

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

1-year efficacy results after MR-guided risk-adapted ... The SOFT study provides MR-guided SABR for 121 patients with abdominal metastases. We achieved a high one-year local control rate of 89.0% using MR-guided SABR.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9694750/

stereotactic body radiotherapy (SBRT) for oligometastatic ... Preliminary data for lung metastasis in oligometastatic patients support SBRT as a viable method of achieving high rates of early local control.

5. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2820082

Stereotactic Ablative Radiotherapy for Gynecological ... This cohort study evaluates the outcomes of stereotactic ablative radiotherapy in patients with oligometastatic and oligoprogressive ...

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. thegreenjournal.com thegreenjournal.com/article/S0167-8140(24)03525-4/fulltext

Feasibility, safety and outcomes of stereotactic ... Use of SBRT in Stage 1 peripheral lung cancers has reported survival rates of ∼ 86 % at 12 months and 54.7–74 % at 24 months [25,26]. In central ...

8. 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.

9. sciencedirect.com sciencedirect.com/science/article/pii/S0167814024035254

Feasibility, safety and outcomes of stereotactic ... Use of SBRT in Stage 1 peripheral lung cancers has reported survival rates of ∼ 86 % at 12 months and 54.7–74 % at 24 months [25], [26]. In central lung tumors, ...

10. frontiersin.org frontiersin.org/article/1620922

Stereotactic body radiotherapy (SBRT) in oligometastatic ... Results are shown in Figure 3. A meta-analysis of four studies reporting mOS following SBRT demonstrated a pooled median OS of 36.7 months (95% ...