Single vs. Multiple Fraction Trial of Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastases/Progression

Recruiting now · Not applicable

Conditions studied: Oligometastatic Disease, Oligoprogression, Toxicity Due to Radiotherapy, Quality of Life

In brief

Stereotactic Ablative Radiotherapy (SABR) is a modern RT technique that delivers high doses of radiation to small tumor targets using highly conformal techniques, while trying to avoid healthy tissues and organs. However, SABR treatment requires increased planning, treatment time, cost and potential for higher toxicity due to the higher dose. The purpose of this study is to compare single fraction (SF) SABR vs. multiple fraction (MF) SABR in regards to toxicities, progression-free survival, quality of life (QoL), and cost-effectiveness. In a subset of patients, we will also compare patient QoL, hospitalization rates, and cost-effectiveness between patients who complete QoL questionnaires, record symptoms and receive healthcare provider-guided intervention vs. patients who complete QoL questionnaires only.

Key facts

Study ID: NCT05784428
Run by: Robert Olson
People needed: 598
Starts: 2025-04-16
Expected to finish: 2035-05-30
Last updated by the study team: 2026-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

1-5 current oligometastatic or oligo-progressive lesions
Age 18 years or older
Able to provide informed consent
Able to complete electronic entry of patient reported outcomes and questionnaires independently or with assistance from a caregiver/family/friend/research staff using electronic methods after providing consent to email use.
Life expectancy > 6 months
Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Controlled primary tumor: defined as at least 3 months since original tumor treated radically, with no progression at primary site (can be considered controlled if no evidence of the primary tumour on imaging [e.g. primary unknown])
A history and physical examination, including ECOG performance status, performed within 6 weeks prior to enrollment
Patient has had a CT chest, abdomen and pelvis or PET-CT within 10 weeks prior to enrollment, and within 13 weeks prior to treatment
Patient has had a nuclear bone scan (if no positron emission tomography-computed tomography [PET-CT]) within 10 weeks prior to enrollment, and within 13 weeks prior to treatment
Patient has had CT or MRI brain imaging if primary has a propensity for central nervous system metastases (if deemed appropriate by the treating investigator) within 10 weeks prior to enrollment, and within 13 weeks prior to treatment.
For patients with known spine metastases, patient has had MRI spine imaging within 10 weeks prior to enrollment, and with 13 weeks prior to treatment.
If solitary lung nodule for which biopsy is unsuccessful or not possible, patient has had an FDG (fluorodeoxyglucose) PET scan or CT (chest, abdomen, pelvis) and bone scan within 10 weeks prior to enrollment, and within 13 weeks prior to treatment
If colorectal primary with rising Carcinoembryonic antigen (CEA), but equivocal imaging, patient has had an FDG PET scan within 10 weeks prior to enrollment, and within 13 weeks prior to treatment
Patient is judged able to:
Maintain a stable position during therapy
Tolerate immobilization device(s) that may be required to deliver SABR safely
Negative pregnancy test for People of Child-Bearing Potential (POCBP) within 4 weeks of RT start date

You may not qualify if…

Uncontrolled concurrent malignant cancer
Lesion in femoral bone requiring surgical fixation
No chemotherapy agents (cytotoxic, or molecularly targeted agents) will be used within the period of time commencing 1 week prior to radiation, lasting until 1 week after the last fraction. See section 5.3.3 regarding this criterion.
Serious medical comorbidities precluding radiotherapy. These include interstitial lung disease in patients requiring thoracic radiation, Crohn's disease in patients where the gastrointestinal (GI) tract will receive radiotherapy, and connective tissue disorders such as lupus or scleroderma.
Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints herein. For patients treated with radiation previously, similar biological effective dose calculations should be used to equate previous doses to the tolerance doses listed below. All such cases should be discussed with the local and study principal investigators (PIs).
Current malignant pleural effusion
Liver metastases located in the "Biliary no fly zone" defined for this trial as common biliary track, cystic duct and distal branches (1 cm) + 5 mm.
Inability to treat all sites of oligometastatic or oligoprogressive disease
Presence of brain metastases as the sole site of disease
Maximum size of 5 cm for lesions outside the brain, except:
Bone metastases over 5 cm may be included, if in the opinion of the local PI it can be treated safely (e.g. rib, scapula, pelvis)
Any brain metastasis > 3.5 cm in size or a total volume of brain metastases greater than 30 cc is excluded
Clinical or radiologic evidence of spinal cord compression. Patients can be eligible if surgical resection has been performed
Patients with spine instability as judged by a Spinal Instability Neoplastic Score (SINS) of >12
Dominant brain metastasis requiring surgical decompression
Surgical resection of all metastases (i.e. no lesion available to be treated with SABR)
Complete response to systemic therapy, defined as the absence of visible disease on imaging
Pregnant or breast feeding

Where it is running

UPMC Whitfield Hospital - Waterford — Waterford, Munster, Ireland (enrolling)
BC Cancer — Prince George, British Columbia, Canada (enrolling)
BC Cancer — Surrey, British Columbia, Canada (enrolling)
BC Cancer — Vancouver, British Columbia, Canada (enrolling)
BC Cancer — Kelowna, British Columbia, Canada (enrolling)
Health Sciences North Research Institute — Greater Sudbury, Ontario, Canada (enrolling)
Princess Margaret Cancer Centre | University Health Network — Toronto, Ontario, Canada (enrolling)
University Hospital Galway — Galway, Connacht, Ireland (enrolling)
St. Luke's Radiation Oncology Network — Dublin, Dublin, Ireland (enrolling)
Mater Private Hospital — Dublin, Leinster, Ireland (enrolling)
Beacon Hospital — Dublin, Leinster, Ireland (enrolling)
Cork University Hospital — Cork, Munster, Ireland (enrolling)
Bon Secours Radiotherapy Cork in Partnership with UPMC Hillman Cancer Centre — Cork, Munster, Ireland (enrolling)
BC Cancer - Victoria — Victoria, British Columbia, Canada

Full record on ClinicalTrials.gov

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