Recruiting

SF SABR vs. MF SABR

Sponsor:

Robert Olson

Code:

NCT05784428

Conditions

Oligometastatic Disease

Oligoprogression

Toxicity Due to Radiotherapy

Quality of Life

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Single fraction SABR

Multiple fraction SABR

QoL reporting alone

QoL reporting, symptom screen and healthcare provider intervention

Study Details

Brief summary:

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.

Conditions

Oligometastatic Disease

Oligoprogression

Toxicity Due to Radiotherapy

Quality of Life

Study ID

NCT05784428

Start date

Apr 16, 2025

Status verified date

Mar, 2026

Completion date

May 30, 2035

Anticipated

Primary completion date

Apr 30, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

598 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Multiple fraction SABR (Arm 1)

Participants randomized to this arm will receive multiple fraction SABR

experimental: Single fraction SABR (Arm 2)

Participants randomized to this arm will receive single fraction SABR

active comparator: Patient-reported outcome (PRO) collection : QoL reporting alone (Arm A)

Participants will complete the EuroQoL-5Dimensions-5levels (EQ-5D-5L) and Functional Assessment of Cancer Therapy-General (FACT-G) prior to each scheduled follow-up (FU).

experimental: QoL reporting and healthcare provider (HCP) intervention guided by symptom screen (Arm B)

  • Patients complete EQ-5D-5L and FACT-G prior to each scheduled FU
  • Patient complete online adaptive symptom screen with HCP intervention, prior to each scheduled appointment

Interventions

Single fraction SABR

Participants randomized to this arm will receive SF SABR

Treatment recommendations are as follows:

Lung: Greater than 2 cm from mediastinum or brachial plexus or if mandatory OAR constraints are met: 30 Gy in 1 fraction

Lung: Within 2 cm of mediastinum or brachial plexus 20 Gy in 1 fraction

Bone, Spine, Adrenal, lymph node/soft tissue: 20 Gy in 1 fraction

Liver: 30 Gy in 1 fraction

Brain: dose as per institutional policy

Multiple fraction SABR

Participants randomized to this arm will receive MF SABR:

Dose/Fractionation are as follows:

Lung: Greater than 2 cm from mediastinum or brachial plexus or if mandatory organ-at-risk (OAR) constraints are met: 48 Gy in 4 fractions (12 Gy/#), 54 Gy in 3 fractions (18 Gy/#), daily or every second day

Lung: Within 2 cm of mediastinum or brachial plexus 60 Gy in 8 fractions (7.5 Gy/#), 50 Gy in 5 fractions (10 Gy/#), daily

Bone: Any bone except spine: 35 Gy in 5 fractions (7 Gy/#), daily

Liver: 54 Gy in 3 fractions (18 Gy/#) or 5 fractions (10.8 Gy/#), daily or every second day

Spine: 24 Gy in 2 fractions (12 Gy/#) or 35 Gy in 5 fractions (7 Gy/#), daily

Adrenal: 40 Gy in 5 fractions (8 Gy/#) or 35 Gy in 5 fractions (7 Gy/#), daily

Lymph node/soft tissue: 40 Gy in 5 fractions (8 Gy/#) or 35 Gy in 5 fractions (7 Gy/#), daily

Brain - dose per institutional policy for stereotactic lesions (no whole brain RT).

QoL reporting alone

Participants randomized to this arm will complete the EQ-5D-5L and FACT-G at baseline and each follow-up visit

QoL reporting, symptom screen and healthcare provider intervention

Participants randomized to this arm will complete the FACT,G, EQ-5D-5L, radiation-symptom screen and receive healthcare provider-guided intervention based on their symptom reports.

Primary outcome measure

  • Adverse events [ Time Frame: At 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months ]
  • Change in patient-reported quality of life [ Time Frame: At 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months ]

Central Contacts and Locations

Central contacts

Robert Olson, MD, MSC, FRCPC

250-645-7300rolson2@bccancer.bc.ca

Jordanna Laing, MSc

250-645-7300jordanna.laing@bccancer.bc.ca

Locations

BC Cancer

Recruiting

Kelowna, British Columbia, Canada

Contacts

Benjamin Mou, MD

250-712-3900benjamin.mou@bccancer.bc.ca

BC Cancer

Recruiting

Prince George, British Columbia, Canada, V2M 7E9

Contacts

Robert A Olson, MD

2506457300rolson2@bccancer.bc.ca

Jordanna Laing

2506457300jordanna.laing@bccancer.bc.ca

Principal Investigator:

Robert A Olson

BC Cancer

Recruiting

Surrey, British Columbia, Canada

Contacts

Devin Schellenberg, MD

604-930-2098dschellenberg@bccancer.bc.ca

BC Cancer

Recruiting

Vancouver, British Columbia, Canada

Contacts

Mitchell Liu, MD

6048776000mliu@bccancer.bc.ca

Health Sciences North Research Institute

Recruiting

Greater Sudbury, Ontario, Canada, P3E 5J1

Contacts

Jessica Richer

705.522.6237jricher@hsnri.ca

Principal Investigator:

Andrew Pearce

Princess Margaret Cancer Centre | University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 1X6

Contacts

Yoona Shin

416-946-4558yoona.shin@uhn.ca

Principal Investigator:

Chiaojung Jillian Tsai

More Information

Sponsor

Robert Olson

Last update posted

Jun 25, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Robert Olson on 2026-06-25.