SABR for Cancer
(SABR-SYNC Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: David Palma
Disqualifiers: ILD, Crohn's, Ulcerative colitis, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?
This study is a phase III multi-institutional randomized trial. Patients will be randomized in a 1:2 ratio between current standard of care treatment (Arm 1) vs. standard of care treatment + SABR (Arm 2) to sites of known disease. Patients will be stratified by two of the strongest prognostic factors, based on a large multi-institutional analysis3: histology (Group 1: hormone-sensitive prostate cancer, breast, or renal; Group 2: all others), and number of metastases (Group 1: 1-3; Group 2: 4-10).
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 cancer?
Research shows that SABR is effective in controlling tumors and improving survival in patients with early-stage non-small cell lung cancer (NSCLC) and is considered a standard treatment for those who cannot undergo surgery. It is also being explored for use in other cancers, like breast cancer with bone metastases, although more evidence is needed in these areas.12345
Is SABR generally safe for humans?
How does SABR treatment differ from other treatments for cancer?
Stereotactic ablative body radiotherapy (SABR) is unique because it delivers high doses of radiation precisely to a target in the body, often in fewer sessions compared to standard radiotherapy. This makes it a preferred option for patients with early-stage non-small cell lung cancer (NSCLC) who cannot undergo surgery, offering a noninvasive alternative with high local efficacy.2451011
Research Team
Eligibility Criteria
This trial is for adults with 1-10 metastases and a primary tumor, who have had recent restaging, confirmed metastatic cancer, can consent, have a good performance status and life expectancy over 6 months. Not eligible if pregnant, severe liver dysfunction or medical conditions that preclude radiotherapy like ILD or Crohn's disease.Inclusion Criteria
My cancer has spread, and this was confirmed by tests.
I can care for myself but may not be able to do active work.
Willing to provide informed consent
See 5 more
Exclusion Criteria
My liver is not working well due to cancer spread.
Pregnant or lactating women
My cancer has spread to the brainstem.
See 7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Patients are randomized to receive either standard of care treatment or standard of care treatment plus SABR
Varies based on treatment arm
Follow-up
Participants are monitored for overall survival and time to next systemic therapy
Approximately 6 years
Extension/Long-term follow-up
Receipt of additional radiation during follow-up will be collected
During year 6
Treatment Details
Interventions
- Stereotactic Ablative Radiotherapy (Radiation Therapy)
Trial OverviewThe study compares standard cancer care treatments to the same treatments plus SABR (a type of precise high-dose radiation therapy) on known disease sites. Patients are grouped by cancer type and number of metastases and randomly assigned in a 1:2 ratio to either treatment arm.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Arm (Arm 2)Experimental Treatment10 Interventions
Consists of treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable (e.g. surgery, RFA, fractionated radiation, chemoradiation) if those are deemed to be preferable by the treating oncologists.
Group II: Standard Arm (Arm 1)Active Control6 Interventions
Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
London Regional Cancer Program of the Lawson Health Research InstituteLondon, Canada
BC Cancer - Centre for the NorthPrince George, Canada
Centre Hospitalier de l'Université de Montréal-CHUMMontréal, Canada
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Who Is Running the Clinical Trial?
David Palma
Lead Sponsor
Trials
4
Patients Recruited
530+
References
Stereotactic ablative body radiotherapy (SABR) for primary and secondary lung tumours. [2022]Stereotactic ablative body radiotherapy (SABR) represents a technological breakthrough in radiotherapy technique, with proven benefits to patients in terms of improved tumour control and overall survival. The key components of SABR are described. The current evidence base for SABR for the treatment of primary and secondary lung tumours is appraised, and key ongoing trials are identified.
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.
Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. [2013]Stereotactic ablative radiotherapy (SABR), otherwise known as stereotactic body radiation therapy (SBRT), is an external beam treatment modality that offers the ability to deliver with high precision large doses of radiation over a limited number of fractions. SABR is currently a standard of care in the treatment of early-stage primary non-small cell lung cancers (NSCLCs) that are medically inoperable and for metastases in many anatomical locations. To date, local control and toxicity parameters with SABR for early-stage NSCLCs are comparable to those found in reports of experiences with surgical resection. It is increasingly apparent that some patients with borderline resectable lung primaries are also looking to SABR as a noninvasive means of therapy. However, randomized comparisons have not been completed to assess survival in operable patients. This review summarizes the advanced technology and radiation concepts that have helped clinicians optimize the use of stereotactic ablative therapies for lung cancer, with an emphasis on the rationale for future continued use of this advanced treatment modality.
Undetected lymph node metastases in presumed early stage NSCLC SABR patients. [2017]Stereotactic body radiation therapy (SBRT, also called stereotactic ablative body radiation SABR) is the treatment of choice for many patients with early-stage non-small cell lung cancer (NSCLC), including those who are unfit for surgery or refuse surgery.
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]Stereotactic ablative body radiotherapy (SABR) is widely used to treat inoperable stage 1 non-small-cell lung cancer (NSCLC), despite the absence of prospective evidence that this type of treatment improves local control or prolongs overall survival compared with standard radiotherapy. We aimed to compare the two treatment techniques.
Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. [2018]The clinical applications of stereotactic body radiotherapy or stereotactic ablative radiotherapy (SABR) for the treatment of primary and metastatic tumours of different organ sites have been expanding rapidly in the recent decade. SABR requires advanced technology in radiotherapy planning and image guidance to deliver a highly conformal ablative dose precisely to targets (or tumours) in the body. Although this treatment modality has shown promising results with regard to tumour control, some serious complications have been observed and reported. In order to achieve a favourable therapeutic ratio, strategies to mitigate the risk of complications must be in place. This overview will summarise the reported serious complications caused by SABR and strategies to mitigate the risk will be discussed.
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.
Real-World Impact of SABR on Stage I Non-Small-Cell Lung Cancer Outcomes at a Scottish Cancer Centre. [2023]Stereotactic ablative body radiotherapy (SABR) offers patients with stage I non-small-cell lung cancer (NSCLC) a safe, effective radical therapy option. The impact of introducing SABR at a Scottish regional cancer centre was studied.
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.
A systematic review of outcomes following stereotactic ablative radiotherapy in the treatment of early-stage primary lung cancer. [2022]Stereotactic ablative body radiotherapy (SABR) describes a radiotherapy (RT) technique where high doses of radiation are precisely delivered to an extracranial target within the body, using either a single fraction of RT or using multiple small numbers of fractions. SABR has now become the standard of care treatment for patients with early-stage non-small-cell lung cancer (NSCLC) for whom surgery is not appropriate. This systematic review considers the evidence supporting the use of SABR in early-stage NSCLC, reported toxicity rates, the use of SABR in centrally located NSCLC, the use of SABR as salvage therapy following surgery or RT, and future potential drug combinations with SABR.
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.