Stereotactic Ablative Body Radiotherapy (SABR) for Oligometastases

NCT02933242 | Active Not Recruiting DMC

• 1 other identifier: H16-02233
• Study Type: interventional
• Target: 399
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Metastatic Tumors

Keywords

Cancer

Outcome Measures

Primary Outcomes (6)

• 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

  At approximately end of year 5 (end of study)

• 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

  At approximately the end of year 1

• 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

  At approximately the end of year 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

  At approximately the end of year 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

  At approximately the end of year 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

  At approximately the end of year 5

Secondary Outcomes (3)

• Overall survival

  At approximately end of year 5 (end of study)

• Progression-free survival

  At approximately end of year 5 (end of study)

• Lesional control rate, defined as lack of further progression

  At approximately end of year 5 (end of study)

Study Arms (1)

Stereotactic arm

EXPERIMENTAL

Stereotactic ablative radiotherapy

Radiation: Stereotactic Ablative Body Radiotherapy

Interventions

Stereotactic Ablative Body Radiotherapy RADIATION

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

Also known as: SABR, SBRT

Stereotactic arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

BC Cancer

Prince George, British Columbia, V2M 7E9, Canada

Location

Related Publications (14)

• 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.

  PMID: 19443337 BACKGROUND

• 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.

  PMID: 18495378 BACKGROUND

• 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.

  PMID: 20406944 BACKGROUND

• 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.

  PMID: 18760543 BACKGROUND

• 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.

  PMID: 19153025 BACKGROUND

• 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.

  PMID: 20456671 BACKGROUND

• 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.

  PMID: 18725106 BACKGROUND

• 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.

  PMID: 7799047 RESULT

• 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.

  PMID: 18618604 RESULT

• 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.

  PMID: 9011700 RESULT

• 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.

  PMID: 19255320 RESULT

• 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.

  PMID: 19255321 RESULT

• 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.

  PMID: 36173619 DERIVED

• 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.

  PMID: 30286739 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Olson, MD

  BC Cancer Agency - Centre for the North

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 14, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)