Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05784428

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

Led by Robert Olson · Updated on 2026-03-11

598

Participants Needed

13

Research Sites

528 weeks

Total Duration

On this page

Sponsors

R

Robert Olson

Lead Sponsor

L

London Regional Cancer Program, Canada

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 1-5 current oligometastatic or oligo-progressive lesions
  • Age 18 years or older
  • Able to provide informed consent
  • Able to complete electronic patient-reported outcomes and questionnaires independently or with assistance
  • Life expectancy greater than 6 months
  • Histologically confirmed cancer with metastatic disease seen on imaging
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Controlled primary tumor for at least 3 months with no progression
  • History and physical exam including ECOG within 6 weeks before enrollment
  • CT chest, abdomen, pelvis or PET-CT within 10 weeks before enrollment and 13 weeks before treatment
  • Bone scan within 10 weeks before enrollment and 13 weeks before treatment if no PET-CT
  • Brain imaging if primary cancer risks CNS metastases within 10 weeks before enrollment and 13 weeks before treatment
  • MRI spine imaging within 10 weeks before enrollment and 13 weeks before treatment for known spine metastases
  • FDG PET scan or CT and bone scan within 10 weeks before enrollment and 13 weeks before treatment if solitary lung nodule biopsy unsuccessful
  • FDG PET scan within 10 weeks before enrollment and 13 weeks before treatment if colorectal primary with rising CEA but unclear imaging
  • Ability to maintain stable position during therapy
  • Ability to tolerate immobilization devices for SABR
  • Negative pregnancy test within 4 weeks of radiation start for people of child-bearing potential
Not Eligible

You will not qualify if you...

  • Uncontrolled active cancer besides study indication
  • Lesion in femoral bone needing surgical fixation
  • Chemotherapy use within 1 week before radiation until 1 week after last fraction
  • Serious medical conditions preventing radiotherapy including interstitial lung disease, Crohn's disease with GI radiation, lupus, scleroderma
  • Significant overlap with previously treated radiation area exceeding dose limits
  • Current malignant pleural effusion
  • Liver metastases in the defined "Biliary no fly zone"
  • Inability to treat all metastatic or progressing sites
  • Brain metastases as the only disease site
  • Lesions larger than 5 cm outside the brain except certain bone metastases deemed safe
  • Brain metastases larger than 3.5 cm or total brain metastases volume over 30 cc
  • Evidence of spinal cord compression unless surgically treated
  • Spine instability score greater than 12
  • Dominant brain metastasis needing surgery
  • Surgical removal of all metastases so no lesion remains for SABR
  • Complete response to systemic therapy with no visible disease
  • Pregnant or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 13 locations

1

BC Cancer

Kelowna, British Columbia, Canada

Actively Recruiting

2

BC Cancer

Prince George, British Columbia, Canada, V2M 7E9

Actively Recruiting

3

BC Cancer

Surrey, British Columbia, Canada

Actively Recruiting

4

BC Cancer

Vancouver, British Columbia, Canada

Actively Recruiting

5

BC Cancer - Victoria

Victoria, British Columbia, Canada

Not Yet Recruiting

6

Princess Margaret Cancer Centre | University Health Network

Toronto, Ontario, Canada, M5G 1X6

Actively Recruiting

7

University Hospital Galway

Galway, Connacht, Ireland, H91 YR71

Actively Recruiting

8

St. Luke's Radiation Oncology Network

Dublin, Dublin, Ireland, D06 E1C9

Actively Recruiting

9

Mater Private Hospital

Dublin, Leinster, Ireland, D07 WKW8

Actively Recruiting

10

Beacon Hospital

Dublin, Leinster, Ireland, D18 AK68

Actively Recruiting

11

Cork University Hospital

Cork, Munster, Ireland, T12 DC4A

Actively Recruiting

12

Bon Secours Radiotherapy Cork in Partnership with UPMC Hillman Cancer Centre

Cork, Munster, Ireland, T12 DV56

Actively Recruiting

13

UPMC Whitfield Hospital - Waterford

Waterford, Munster, Ireland, X91 DH9W

Actively Recruiting

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Research Team

R

Robert Olson, MD, MSC, FRCPC

CONTACT

J

Jordanna Laing, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

4

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