Ablative Radiotherapy to Restrain Every Metastasis Safely Treatable (ARREST-2): A Randomized Phase II/III Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About this trial

This is a phase II/III international multicentre randomized trial. Patients will be randomized in a 1:2 ratio between the standard of care (Arm 1) and SABR (Arm 2) to all sites of disease. The study will start as a phase II trial with an opportunity to convert to a phase III trial. The objective of this trial is to determine the impact of SABR on overall survival, progression-free survival, quality of life, and toxicity in patients with polymetastatic disease.

Eligibility criteria

Qualifiers

Age 18 or older

willing and able to provide informed consent

ECOG performance status 0-2

Life expectancy > or equal to 6 months

Disqualifiers

Serious medical comorbidities precluding radiotherapy. These include interstitial lung disease in patients requiring thoracic radiation, Chrohn's disease in patients where the GI tract will receive radiotherapy, ulcerative colitis where the bowel will receive radiotherapy and connective tissue disorders such as lupus or scleroderma.

For patients with liver metastases, moderate/severe liver dysfunction (Child-Pugh B or C)

Substantial overlap with a previously treated radiation volume. Prior radiotherapy is allowed, as long as the composite plan meets dose constraints herein. For patients treated with radiation previously, biologically effective dose calculations should be used to equate previous doses to the tolerance doses listed in Appendix 1. All such cases must be discussed with the study PI.

Inability to treat all sites of disease. Any brain metastasis >3 cm in size or a total volume of brain metastases greater than 30 cc.

Trial design

Treatments tested in this trial

  • Arm 2: SABR
  • Arm 1: Standard of Care

Treatment groups

138 Participants
are divided into 2 treatment groups