Non-surgical treatment for kidney tumors using targeted radiation therapy
Phase II Study: Stereotactic Ablative Radiotherapy for Renal Tumors
This study is testing a new non-surgical radiation treatment for kidney tumors to see if it can help patients who can't have surgery feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Barrie, Ontario and 1 other locations) |
| Trial ID | NCT03747133 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of Stereotactic Ablative Radiosurgery (SABR) as a non-invasive treatment option for patients with renal tumors, particularly those who are not suitable candidates for surgery. The approach involves delivering high doses of radiation directly to the tumor while minimizing damage to surrounding healthy tissue. Patients will undergo assessments before and after treatment, with follow-up evaluations every four months for up to two years, during which they will complete quality of life questionnaires and receive standard imaging. The goal is to provide an effective alternative treatment for renal cell carcinoma, especially in older patients.
Who should consider this trial
Good fit: Ideal candidates include patients with solid kidney masses that are inoperable due to high surgical risk or personal choice, and who have a performance status of 0-3.
Not a fit: Patients with multiple active metastases, end-stage renal failure, or certain hereditary syndromes will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a viable non-surgical option for patients with renal tumors, improving their quality of life and treatment outcomes.
How similar studies have performed: Other studies have shown promising results with SABR for various tumors, indicating potential success for this approach in renal tumors as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Solid Kidney Mass (primary RCC or metastasis) amenable to SABR ≤6cm * Histological or radiological diagnosis of renal tumor * Inoperable: High risk for surgery or declined surgery * ECOG performance status of 0-3 Exclusion Criteria: * ≥5 active metastases * Sysstemic therapy (except endocrine therapy) wthin 6 days prior to SABR * Prior abdominal radiotherapy with fields overlap resulting in excessive doses to the involved kidney * Patients with end stage renal failure \> 4(KDOQI guidelines) * Familial Syndrome: Von Hippel-Lindau disease, Polycystic Kidney Disease, Hereditary Papillary RCC or Tuber Sclerosis
Where this trial is running
Barrie, Ontario and 1 other locations
- Royal Victoria Regional Health Centre — Barrie, Ontario, Canada (Not_yet_recruiting)
- University Health Network - Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Andrew McPartlin, MD — The Princess Margaret Cancer Foundation
- Study coordinator: Andrew McPartlin, MD
- Email: andrew.mcpartlin@rmp.uhn.ca
- Phone: 416-946-4501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.