🏛️ Verified NIH Record • Updated 2026-06-03

The Role of Stereo-tActic BoDy RadIotherApy iN Oligo-Progressive MalignanT Disease (NCT04122469)

🔵 Active, Not Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: University Health Network, Toronto

🩺 Plain-English Summary (8th-Grade Level)

Systemic therapy is the main treatment for patients with metastatic cancers. Oligo-progression has become a recognized entity for metastatic cancer and it is thought that a subset of cancer cells may develop heterogeneity and resistant clones while receiving systemic therapy. This results in overall tumor response but progression in metastatic sites. Current standard is to change systemic therapies. With advancing technologies, stereotactic body radiation therapy is being used to deliver high doses of focused radiation to the disease site, while minimizing risk of injury to the surrounding organs. SBRT is increasingly being used in patients presenting oligo-metastatic disease, and is recognized as having a potential for cure. This study will investigate the use of SBRT for breast and genito-urinary cancer patients with oligo-progression. Patients will be seen before and at the end of treatment and will be followed at 4 month intervals for up to 2 years. During the visits participants will complete quality of life questionnaires and will have standard of care imaging. Patients will also have the option to provide blood at baseline, during treatment, and at various follow up time points for analysis of ctDNA

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (18 items) and avoid the listed exclusions (11 items).

Location: Princess Margaret Cancer Centre — Toronto, Ontario

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • ≥6 progressive metastases
  • Evidence of spinal cord compression or acute event requiring urgent/emergency radiotherapy
  • Prior radiotherapy, with fields overlapping, resulting in excessive doses to organs at risk
  • Previous radical RT in the area of OP
  • Inability to safely treat all sites of progressing metastases
  • Patient cannot tolerate physical set-up required for SBRT
  • Treatment plan respecting normal tissue tolerances using dose fractionation specified within the protocol cannot be achieved
  • Active bowel obstruction, if treating abdominal/pelvic site
  • Neuroendocrine, lymphoma, myeloma or germ cell malignancies
  • Familial syndromes: Von Hippel-Lindau disease, Polycystic Kidney Disease, Hereditary Papillary RCC or Tuberous Sclerosis

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • Princess Margaret Cancer Centre — Toronto, Ontario

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗