SABR for Oligometastatic Cancer
(SABR-COMET-3 Trial)
Recruiting in Palo Alto (17 mi)
+17 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: British Columbia Cancer Agency
Must not be taking: Chemotherapy agents
Disqualifiers: Concurrent cancer, Poor lung function, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?Stereotactic Ablative Radiotherapy (SABR) is a modern RT technique that delivers high doses of radiation to small tumor targets using highly conformal techniques. SABR is non-invasive and delivered on an outpatient basis. The purpose of this study is to compare the effect of SABR, relative to standard of care (SOC) alone, on overall survival, progression-free survival, toxicity, and quality of life. An integrated economic evaluation will determine the cost per quality of life year gained using SABR (vs. SOC) and a translational component will enable identification of predictive/prognostic biomarkers of the oligometastatic state.
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 data supports the effectiveness of the treatment Stereotactic Ablative Body 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 effective in controlling tumors in various organs with a high success rate, and may even be curative in some cases.
12345Is SABR generally safe for treating oligometastatic cancer?
Stereotactic Ablative Body Radiotherapy (SABR) is generally considered safe for treating small lung tumors and oligometastases, with studies showing low toxicity levels. However, there are concerns about potential high-grade toxic effects and specific adverse effects like lung and chest wall issues, and rare cases of vertebral fractures.
26789How is the treatment SABR different from other treatments 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 emerging as a promising option for treating oligometastatic cancer, potentially offering high local control rates and even curative outcomes in some cases.
134510Eligibility Criteria
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 am 18 years old or older.
+17 more
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
+11 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Stereotactic Arm (Arm 2)Experimental Treatment1 Intervention
Stereotactic ablative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist
Group II: Standard of Care Treatment (Arm 1)Active Control1 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, Australia, 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 Australia 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
BC CancerKelowna, Canada
BC CancerVictoria, Canada
Tom Baker Cancer CentreCalgary, Canada
London Health Sciences CentreLondon, Canada
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
British Columbia Cancer AgencyLead Sponsor
Bon Secours Cork Cancer CentreCollaborator
Walker Family Cancer CentreCollaborator
Cancer Research UK Edinburgh CentreCollaborator
UPMC Hillman Cancer CentreCollaborator
Beatson West of Scotland Cancer CentreCollaborator
Tom Baker Cancer CentreCollaborator
Riverina Cancer Care CentreCollaborator
London Regional Cancer Program, CanadaCollaborator
The AlfredCollaborator
References
Single Fraction Stereotactic Ablative Body Radiotherapy for Oligometastasis: Outcomes from 132 Consecutive Patients. [2019]Stereotactic ablative body radiotherapy (SABR) is currently used to treat oligometastases, but the optimum dose/fractionation schedule is unknown. In this study, we evaluated outcomes after single fraction SABR in patients with oligometastatic disease.
Colorectal Histology Is Associated With an Increased Risk of Local Failure in Lung Metastases Treated With Stereotactic Ablative Radiation Therapy. [2022]Stereotactic ablative radiation therapy (SABR) is increasingly used to treat lung oligometastases. We set out to determine the safety and efficacy of this approach and to identify factors associated with outcomes.
American Radium Society Appropriate Use Criteria for Radiation Therapy in Oligometastatic or Oligoprogressive Non-Small Cell Lung Cancer. [2022]Recent randomized studies have suggested improvements in progression-free and overall survival with the addition of stereotactic body radiation therapy (SBRT, also known as SABR) in patients with oligometastatic non-small cell lung cancer. Given the novelty and complexity of incorporating SBRT in the oligometastatic setting, the multidisciplinary American Radium Society Lung Cancer Panel was assigned to create appropriate use criteria on SBRT as part of consolidative local therapy for patients with oligometastatic and oligoprogressive non-small cell lung cancer.
Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial. [2020]Stereotactic ablative body radiotherapy (SABR) is an emerging noninvasive approach for the treatment of oligometastases. Limited prospective evidence is available in breast cancer.
New concepts and insights into the role of radiation therapy in extracranial metastatic disease. [2013]Stereotactic ablative radiotherapy (SABR) is a form of very precise radiotherapy that delivers high doses to tumors while sparing adjacent organs at risk. Recent data show that SABR is a low-toxic and highly effective local treatment for metastatic localizations in various organs, obtaining local control rates of approximately 80%. Experimental evidence also suggests that SABR may play an important therapeutic role in oligometastatic/oligorecurrent/oligoprogressive patients, a subset of cancer patients who are probably in an intermediate disease state between localized disease and widespread dissemination. There is a strong biological and clinical rationale in combining the high local control rates achievable with SABR with effective systemic therapies, and recent results of pilot studies indicate that SABR may have a potential impact on prognosis in this subgroup of patients, being 'curative' in around 20-25% of cases. This paper reviews and discusses basic concepts and clinical applications of SABR in oligometastatic patients.
Stereotactic ablative radiotherapy for small lung tumors with a moderate dose. Favorable results and low toxicity. [2022]Stereotactic ablative body radiotherapy (SBRT, SABR) is being increasingly applied because of its high local efficacy, e.g., for small lung tumors. However, the optimum dosage is still under discussion. Here, we report data on 45 lung lesions [non-small cell lung cancer (NSCLC) or metastases] in 39 patients treated between 2009 and 2010 by SABR.
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]After the publication of the landmark SABR-COMET trial, concerns arose regarding high-grade toxic effects of treatment with stereotactic ablative body radiotherapy (SABR) for oligometastases.
A randomised phase II trial of Stereotactic Ablative Fractionated radiotherapy versus Radiosurgery for Oligometastatic Neoplasia to the lung (TROG 13.01 SAFRON II). [2022]Stereotactic ablative body radiotherapy (SABR) is emerging as a non-invasive method for precision irradiation of lung tumours. However, the ideal dose/fractionation schedule is not yet known. The primary purpose of this study is to assess safety and efficacy profile of single and multi-fraction SABR in the context of pulmonary oligometastases.
Pathological vertebral fracture after stereotactic body radiation therapy for lung metastases. Case report and literature review. [2022]Stereotactic body radiation therapy (SBRT) is a radiation technique used in patients with oligometastatic lung disease. Lung and chest wall toxicities have been described in the patients but pathological vertebral fracture is an adverse effect no reported in patients treated with SBRT for lung metastases.
Stereotactic Abative Body Radiotherapy (SABR) for Oligometastatic Prostate Cancer: A Prospective Clinical Trial. [2022]Stereotactic ablative body radiotherapy (SABR) is an emerging treatment option for oligometastatic prostate cancer. However, limited prospective evidence is available.