SABR for Oligometastatic Cancer

(SABR-COMET 10 Trial)

Recruiting at 13 trial locations

Overseen By David Palma, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: David Palma

Disqualifiers: Interstitial lung disease, Crohn's disease, Lupus, Scleroderma, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

204 Participants Needed

Trial Summary

What is the purpose of this trial?

In patients with a limited oligometastatic burden (cancer has spread but is not yet considered metastatic), emerging evidence suggests that treatment of all sites of disease with ablative therapies can improve patient outcomes, including overall- and progression-free survival. The application of Stereotactic Ablative Radiotherapy (SABR) for patients with 4-10 metastatic deposits appears promising, yet it is unclear if all patients with greater than 3 oligometastatic lesions benefit from ablative therapies in terms of improved Overall Survival (OS), Progression Free Survival (PFS), or quality of life. The purpose of this study is to assess the impact of SABR, compared to standard of care treatment, on overall survival, oncologic outcomes, and quality of life in patients with a controlled primary tumor and 4-10 metastatic lesions.

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

Research shows that SABR can improve survival rates and control cancer spread in patients with oligometastatic non-small cell lung cancer. It is also considered a low-toxic and effective treatment for various metastatic cancers, achieving local control in about 80% of cases and potentially being curative in 20-25% of patients. ^{1 2 3 4 5}

Is SABR safe for treating oligometastatic cancer?

Stereotactic Ablative Radiotherapy (SABR) is generally considered safe for treating small lung tumors and oligometastases, with studies showing low toxicity levels. However, there have been concerns about high-grade toxic effects and rare cases of adverse effects like vertebral fractures. ^{5 6 7 8 9}

How is the treatment SABR unique for oligometastatic cancer?

Stereotactic Ablative Radiotherapy (SABR) is unique because it delivers very precise, high doses of radiation directly to tumors while minimizing damage to nearby healthy organs. This noninvasive approach is particularly effective for patients with oligometastatic cancer, which is a state where cancer has spread but not extensively, and it can potentially improve survival rates and even be curative in some cases. ^{1 2 3 4 10}

Research Team

David Palma, MD

Principal Investigator

London Health Sciences Centre, Lawson Health Research Institute

Robert Olson

Principal Investigator

British Columbia Cancer - Centre for the North

Suresh Senan, MRCP, FRCR

Principal Investigator

Amsterdam University Medical Centre, VUmc Site

Stephen Harrow, MD, PhD

Principal Investigator

Beaston West of Scotland Cancer Centre

Eligibility Criteria

This trial is for adults with cancer that has spread to 4-10 places but isn't widespread. They must have had their original tumor controlled for at least 3 months, be able to undergo treatment safely, and have a life expectancy over 6 months. It's not for those with large tumors in certain areas, brainstem involvement, spinal cord compression, or serious health issues that radiotherapy could worsen.

Inclusion Criteria

All my cancer areas can be safely treated.

I can care for myself but may need occasional help.

My original cancer site has been stable for at least 3 months after treatment.

Exclusion Criteria

My cancer has spread to my digestive system, certain lymph nodes, or skin.

My cancer has spread to the brainstem.

Pregnant or lactating women

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Stereotactic Ablative Radiotherapy (SABR) and standard of care treatment, which may include chemotherapy, immunotherapy, hormones, or observation

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including overall survival and progression-free survival

6 years

Treatment Details

Interventions

• Stereotactic Ablative Radiotherapy

Trial Overview The study tests if Stereotactic Ablative Radiotherapy (SABR) can improve survival and quality of life compared to standard treatments like chemotherapy or observation in patients with limited metastatic cancer. Participants will either receive SABR or the standard care to see which is more effective.

Participant Groups

Group I: Stereotactic Arm Experimental Treatment 5 Interventions

Stereotactic ablative radiotherapy, plus standard of care treatment: chemotherapy, immunotherapy, hormones, or observation given at the discretion of the treating oncologist.

Group II: Standard arm Active Control 5 Interventions

Standard of care treatment: palliative radiotherapy, chemotherapy, immunotherapy, hormones, or observation, is at the discretion of the treating 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?

David Palma

Lead Sponsor

Trials

4

Recruited

530+

Amsterdam University Medical Centre, VUmc Site

Collaborator

Trials

3

Recruited

36,500+

British Columbia Cancer - Centre for the North

Collaborator

Trials

1

Recruited

200+

Beaston West of Scotland Cancer Centre

Collaborator

Trials

1

Recruited

200+

London Health Sciences Centre

Collaborator

Trials

151

Recruited

60,400+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

American Radium Society Appropriate Use Criteria for Radiation Therapy in Oligometastatic or Oligoprogressive Non-Small Cell Lung Cancer. [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

New concepts and insights into the role of radiation therapy in extracranial metastatic disease. [2013]

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

Single Fraction Stereotactic Ablative Body Radiotherapy for Oligometastasis: Outcomes from 132 Consecutive Patients. [2019]

5. United States 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. [2022]

6. England 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). [2022]

7. United States 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. [2023]

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

Pathological vertebral fracture after stereotactic body radiation therapy for lung metastases. Case report and literature review. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy for small lung tumors with a moderate dose. Favorable results and low toxicity. [2022]

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

Stereotactic Abative Body Radiotherapy (SABR) for Oligometastatic Prostate Cancer: A Prospective Clinical Trial. [2022]