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Metastatic TumorsNCT02933242

Stereotactic Ablative Body Radiotherapy (SABR) for Oligometastases

A study testing Stereotactic Ablative Body Radiotherapy in people with Metastatic Tumors, run by British Columbia Cancer Agency at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Tumors
What is being tested?
Stereotactic Ablative Body Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
399 participants
Where
1 siteCanada
Study dates
Nov 2016to Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to provide informed consent
  • Histologically confirmed malignancy with metastatic disease detected on imaging.
  • Biopsy of metastasis is preferred, but not required.
  • Primary tumour treated radically or controlled by prior palliative radiotherapy or systemic therapy
  • Maximum 5 metastases eligible for SABR (either 5 in total or 5 not controlled by prior treatment)
  • Standard of care tests prior to SABR CT simulation within 14 weeks:
Show all 31Show fewer
  • Brain CT or MRI imaging (for tumour sites with propensity for brain metastasis)
  • Body imaging:
  • CT chest/abdomen/pelvis, with or without bone scan (at discretion of study doctor), required if no PET-CT is performed
  • PET-CT or PSMA-PET is only required for specific evidence-based indications, and in such cases the CT neck/chest/abdomen/pelvis and bone scan are not required:
  • MRI spine for patients with vertebral or paraspinal metastases
  • For other indications, at the discretion of the treating oncologists, e.g. PET-CT scans may be done but are not required.
  • Blood tests as per standard of care
  • Pregnancy test for women of child-bearing age
  • ECOG performance status 0-2
  • All sites of progressive disease can be safely treated based on criteria below
  • For non-brainstem mets, maximum size of 3cm if using single fraction radiosurgery.
  • If size is from 3.1 to 4cm, 25-35Gy/5 can be considered
  • All brain metastases cases need approval from Stereotactic Radiosurgery (SRS) rounds
  • Maximum size of 6 cm for lesions outside the brain, except:
  • Bone metastases over 6 cm may be included, if in the opinion of the local PI it can be treated safely (e.g. rib, scapula, pelvis)
  • Life expectancy > 6 months
  • In many scenarios, this is best estimated by a multidisciplinary opinion from disease site experts, often obtained by presentation at multidisciplinary tumours rounds.
  • Not a candidate for surgical resection at all sites: surgery to all sites not recommended by multidisciplinary team, or unfit or declining surgery.
  • No chemotherapy agents (cytotoxic, or molecularly targeted agents) will be used within the period of time commencing 2 weeks prior to radiation, lasting until 1 week after the last fraction. Certain chemotherapy agents may require a longer break prior to or after SABR if protocols dictate. Hormonal therapy during SABR is allowed.
  • Patients with metastases that have been previously treated may be eligible for this SABR protocol:
  • If the previous treatment was systemic therapy, the patient may be eligible, if the metastases have demonstrated a complete radiologic response
  • If the previous treatment was by a local non-radiation means (e.g. prior resection, RFA or microwave ablation), then SABR may be considered for residual/recurrent disease
  • If the previous treatment was SABR, the patient is not eligible unless the new site(s) was/were not previously treated
  • If the previous treatment was conventional RT, SABR could be considered if it can be delivered safely. In such a circumstance it must be presented in a multidisciplinary setting for approval.
  • Review and consensus by 3 disease site experts, or tumour group conference, for eligibility/prognosis Patients must be able and willing to complete quality of life questionnaires in English, and other assessments that are a part of this study, via paper or online using REDCap (if email address is provided by participant on the informed consent) Note: The potential treating SABR radiation oncologist reserves the right to require a multidisciplinary note documenting life expectancy, other treatment options and suitability for SABR.

Who cannot join

  • Serious medical co-morbidities precluding radiotherapy
  • Bone metastasis in a femoral bone if risk of pending fracture is high
  • Participants with 1-3 brain metastasis and no disease elsewhere (these participants should not be accrued but treated with stereotactic radiotherapy as per results of published randomized trials)
  • Complete response to first-line chemotherapy (i.e. no measurable target for SABR)
  • Persistent malignant pleural effusion
  • Inability to treat all sites of active disease with ablative intent
Show all 10Show fewer
  • Clinical or radiological evidence of spinal cord compression
  • Dominant brain metastasis requiring surgical decompression
  • a candidate for a clinical trial that randomizes between SABR and a standard treatment
  • Pregnant or lactating women

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • BC Cancer

    Prince George, British Columbia, V2M 7E9

Other trials in Canada

About this study

Official title: Phase II Non-randomized Trial of Stereotactic Ablative Radiotherapy (SABR) for Oligometastases

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

Read the detailed description

To assess quality of life and side effects in participants with up to 5 metastatic cancer lesions treated with a comprehensive oligometastatic SABR treatment program. Secondarily, the investigators will document the disease free and overall survival.

Rationale:

The oligometastatic state was first defined in 1995 and refers to a stage of disease where cancer has spread beyond the site of origin, but is not yet widely metastatic. In such a state of limited metastatic disease, it is hypothesized that eradication of all sites of metastatic disease could result in long-term survival, or even cure, in some participants. Ablation of metastatic deposits can be achieved through several techniques, including surgery, radiofrequency ablation (RFA), or through Stereotactic ablative body radiotherapy (SABR), a new radiotherapy technology that delivers very large, hypofractionated doses of radiotherapy to small tumor targets, with high rates of local control.

Clinical evidence to support the presence of an oligometastatic state is controversial. However, there is emerging low quality evidence in both the surgical and SABR literature that this state may exist. In a study of over 5200 participants with lung metastases who underwent surgical resection, a 5-year survival of 36% was reported in participants who achieved a complete resection, much higher than would be expected for stage IV disease.3 Similarly, in participants treated with SABR for 1-3 lung metastases from a variety of primary tumors, local control with SABR was 96% at 2-years, and 2-year survival was 39%. Long-term survival has been demonstrated in participants treated for oligometastases with surgery or SABR at several other tumor sites, including liver, brain, bone, and adrenal metastases. The risk of further metastases after ablative treatment is up to 60-80% in some studies. SABR can also be used for further salvage at newly progressive sites (oligoprogression).

Despite the apparent achievement of long-term survival with ablative treatment for oligometastatic disease, the level of evidence to support such treatments is weak, often based on single-arm studies without appropriate controls. Participants included in such reports are highly selected, based on good performance status and slow pace of tumor progression. It has been suggested that the long-term survival achieved with treatment of oligometastases is a result of the selection of fit participants with very slow-growing tumors, rather than the result of treatment intervention.

Randomized trials are therefore necessary to establish the utility of ablative treatment of oligometastatic disease, and therefore the BCCA oligometastatic SABR group, recommends that participants be considered for a randomized control before being offered SABR on this current trial. In some circumstances, participants may not be comfortable with this approach, or their physicians do not have clinical equipoise, and therefore SABR for oligometastatic disease may be appropriate. BCCA has decided that given the limited evidence for SABR in this setting, it will not be offered off trial. The main focus of this trial is to assess the side effects and quality of life post SABR. This trial aims to provide a clear informed consent process, including the limited evidence for SABR off trial, and potential harm from SABR, for participants opting to pursue SABR for oligometastases.

This is a non-randomized phase II trial where all participants will receive experimental SABR to all sites of metastatic disease. The investigators will accrue 200 participants to assess toxicity associated with this experimental treatment.

Being tested
Stereotactic Ablative Body Radiotherapy
Keywords
Cancer
Medical subject headings
Neoplasm Metastasis, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic Ablative Body RadiotherapyRadiation

    Also called SABR, SBRT

    The total dose and number of fractions will depend on the site of disease. Treatment will be given daily, or every other day, over 1 -3 weeks

Study groups in NCT02933242
Study groupRoleWhat they receive
Stereotactic armExperimentalStereotactic ablative radiotherapy
Receives: Radiation: Stereotactic Ablative Body Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient-reported Quality of life, function and health status using BC Cancer's Prospective Outcomes and Support Initiative (POSI).

    Measuring percentage change in patient reported QoL before and after SABR treatment

    Measured: At approximately end of year 5 (end of study)

  2. Toxicity as Assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4 for each organ treated (e.g. liver, lung, bone)]

    Prevalence of various SAE graded events

    Measured: At approximately the end of year 1

  3. Toxicity as Assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4 for each organ treated (e.g. liver, lung, bone)]

    Prevalence of various SAE graded events

    Measured: At approximately the end of year 2

  4. Toxicity as Assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4 for each organ treated (e.g. liver, lung, bone)]

    Prevalence of various SAE graded events

    Measured: At approximately the end of year 3

  5. Toxicity as Assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4 for each organ treated (e.g. liver, lung, bone)]

    Prevalence of various SAE graded events

    Measured: At approximately the end of year 4

  6. Toxicity as Assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4 for each organ treated (e.g. liver, lung, bone)]

    Prevalence of various SAE graded events

    Measured: At approximately the end of year 5

Secondary outcomes (3)
  1. Overall survival

    Defined as time until death from any cause

    Measured: At approximately end of year 5 (end of study)

  2. Progression-free survival

    Defined as time to either progression or death

    Measured: At approximately end of year 5 (end of study)

  3. Lesional control rate, defined as lack of further progression

    Assessed retrospectively using RECIST criteria

    Measured: At approximately end of year 5 (end of study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionAug 2026
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
399 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02933242
Sponsor's protocol ID
H16-02233
Status last verified
Sep 2026
First submitted
6 Oct 2016
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Louie AV, Rodrigues G, Yaremko B, Yu E, Dar AR, Dingle B, Vincent M, Sanatani M, Younus J, Malthaner R, Inculet R. Management and prognosis in synchronous solitary resected brain metastasis from non-small-cell lung cancer. Clin Lung Cancer. 2009 May;10(3):174-9. doi: 10.3816/CLC.2009.n.024.

    PubMed 19443337
  • Milano MT, Katz AW, Schell MC, Philip A, Okunieff P. Descriptive analysis of oligometastatic lesions treated with curative-intent stereotactic body radiotherapy. Int J Radiat Oncol Biol Phys. 2008 Dec 1;72(5):1516-22. doi: 10.1016/j.ijrobp.2008.03.044. Epub 2008 May 19.

    PubMed 18495378
  • Inoue T, Katoh N, Aoyama H, Onimaru R, Taguchi H, Onodera S, Yamaguchi S, Shirato H. Clinical outcomes of stereotactic brain and/or body radiotherapy for patients with oligometastatic lesions. Jpn J Clin Oncol. 2010 Aug;40(8):788-94. doi: 10.1093/jjco/hyq044. Epub 2010 Apr 20.

    PubMed 20406944
  • Milano MT, Philip A, Okunieff P. Analysis of patients with oligometastases undergoing two or more curative-intent stereotactic radiotherapy courses. Int J Radiat Oncol Biol Phys. 2009 Mar 1;73(3):832-7. doi: 10.1016/j.ijrobp.2008.04.073. Epub 2008 Aug 28.

    PubMed 18760543
  • Treasure T, Fallowfield L, Farewell V, Ferry D, Lees B, Leonard P, Macbeth F, Utley M; Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC) trial development group. Pulmonary metastasectomy in colorectal cancer: time for a trial. Eur J Surg Oncol. 2009 Jul;35(7):686-9. doi: 10.1016/j.ejso.2008.12.005. Epub 2009 Jan 18.

    PubMed 19153025
  • Primrose J, Treasure T, Fiorentino F. Lung metastasectomy in colorectal cancer: is this surgery effective in prolonging life? Respirology. 2010 Jul;15(5):742-6. doi: 10.1111/j.1440-1843.2010.01759.x. Epub 2010 Apr 23.

    PubMed 20456671
  • Timmerman RD. An overview of hypofractionation and introduction to this issue of seminars in radiation oncology. Semin Radiat Oncol. 2008 Oct;18(4):215-22. doi: 10.1016/j.semradonc.2008.04.001. No abstract available.

    PubMed 18725106
  • Hellman S, Weichselbaum RR. Oligometastases. J Clin Oncol. 1995 Jan;13(1):8-10. doi: 10.1200/JCO.1995.13.1.8. No abstract available.

    PubMed 7799047
  • Macdermed DM, Weichselbaum RR, Salama JK. A rationale for the targeted treatment of oligometastases with radiotherapy. J Surg Oncol. 2008 Sep 1;98(3):202-6. doi: 10.1002/jso.21102.

    PubMed 18618604
  • Pastorino U, Buyse M, Friedel G, Ginsberg RJ, Girard P, Goldstraw P, Johnston M, McCormack P, Pass H, Putnam JB Jr; International Registry of Lung Metastases. Long-term results of lung metastasectomy: prognostic analyses based on 5206 cases. J Thorac Cardiovasc Surg. 1997 Jan;113(1):37-49. doi: 10.1016/s0022-5223(97)70397-0.

    PubMed 9011700
  • Rusthoven KE, Kavanagh BD, Burri SH, Chen C, Cardenes H, Chidel MA, Pugh TJ, Kane M, Gaspar LE, Schefter TE. Multi-institutional phase I/II trial of stereotactic body radiation therapy for lung metastases. J Clin Oncol. 2009 Apr 1;27(10):1579-84. doi: 10.1200/JCO.2008.19.6386. Epub 2009 Mar 2.

    PubMed 19255320
  • Rusthoven KE, Kavanagh BD, Cardenes H, Stieber VW, Burri SH, Feigenberg SJ, Chidel MA, Pugh TJ, Franklin W, Kane M, Gaspar LE, Schefter TE. Multi-institutional phase I/II trial of stereotactic body radiation therapy for liver metastases. J Clin Oncol. 2009 Apr 1;27(10):1572-8. doi: 10.1200/JCO.2008.19.6329. Epub 2009 Mar 2.

    PubMed 19255321
  • Olson R, Liu M, Bergman A, Mou B, Abraham H, Leclerc C, Carolan H, Schellenberg D, Jiang W, Alexander A, Hsu F, Miller S, Atrchian S, Chan E, Ho C, Mohamed I, Lin A, Berrang T, Bang A, Gautam D, Chng N, Matthews Q, Huang V, Mestrovic A, Hyde D, Lund C, Pai H, Valev B, Lefresene S, Tyldesley S, Baker S. Five-year follow-up of the SABR-5 trial: primary toxicity analysis of stereotactic ablative radiotherapy for up to five oligometastases. Radiother Oncol. 2026 Jul;220:111532. doi: 10.1016/j.radonc.2026.111532. Epub 2026 May 15.

    PubMed 42140754
  • Olson R, Jiang W, Liu M, Bergman A, Schellenberg D, Mou B, Alexander A, Carolan H, Hsu F, Miller S, Atrchian S, Chan E, Ho C, Mohamed I, Lin A, Berrang T, Bang A, Chng N, Matthews Q, Baker S, Huang V, Mestrovic A, Hyde D, Lund C, Pai H, Valev B, Lefresene S, Tyldesley S. 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. JAMA Oncol. 2022 Nov 1;8(11):1644-1650. doi: 10.1001/jamaoncol.2022.4394.

    PubMed 36173619
  • Olson R, Liu M, Bergman A, Lam S, Hsu F, Mou B, Berrang T, Mestrovic A, Chng N, Hyde D, Matthews Q, Lund C, Glick D, Pai H, Basran P, Carolan H, Valev B, Lefresene S, Tyldesley S, Schellenberg D. Population-based phase II trial of stereotactic ablative radiotherapy (SABR) for up to 5 oligometastases: SABR-5. BMC Cancer. 2018 Oct 4;18(1):954. doi: 10.1186/s12885-018-4859-7.

    PubMed 30286739

Questions about this trial

What is this clinical trial studying?

A study testing Stereotactic Ablative Body Radiotherapy in people with Metastatic Tumors, run by British Columbia Cancer Agency at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-reported Quality of life, function and health status using BC Cancer's Prospective Outcomes and Support Initiative (POSI). (time frame: At approximately end of year 5 (end of study)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02933242, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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