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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRobert Olson

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Single fraction SABR
  • Multiple fraction SABR
  • QoL reporting alone
  • QoL reporting, symptom screen and healthcare provider intervention

Treatment groups

598 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Robert Olson

Lead sponsor

British Columbia Cancer Agency

Sponsor institution

London Regional Cancer Program, Canada

Collaborator

Tom Baker Cancer Centre

Collaborator

Princess Margaret Hospital, Canada

Collaborator