Clinical trial · Interventional
Stereotactic Ablative Body Radiotherapy (SABR) for Oligometastases
Phase II Non-randomized Trial of Stereotactic Ablative Radiotherapy (SABR) for Oligometastases
NCT02933242CI-TRIAL-00097291active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Tumors | Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Ablative Body Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stereotactic arm
- description
- Stereotactic ablative radiotherapy
- interventionNames
- Radiation: Stereotactic Ablative Body Radiotherapy
Primary outcomes (6)
- measure
- Patient-reported Quality of life, function and health status using BC Cancer's Prospective Outcomes and Support Initiative (POSI).
- timeFrame
- At approximately end of year 5 (end of study)
- description
- Measuring percentage change in patient reported QoL before and after SABR treatment
- measure
- Toxicity as Assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4 for each organ treated (e.g. liver, lung, bone)]
- timeFrame
- At approximately the end of year 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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
References
Publications (15)
- BACKGROUNDLouie 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
- BACKGROUNDMilano 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
- BACKGROUNDInoue 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
- BACKGROUNDMilano 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
- BACKGROUNDTreasure 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
- BACKGROUNDPrimrose 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
- BACKGROUNDTimmerman 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.