RecruitingNot ApplicableNCT03747133

SABR for Renal Tumors

Phase II Study: Stereotactic Ablative Radiotherapy for Renal Tumors


Sponsor

University Health Network, Toronto

Enrollment

45 participants

Start Date

Nov 1, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

Renal Cell Carcinoma (RCC) is the most common type of kidney cancer. The usual treatment for this type of cancer is surgery. Considering the most common patients are an average age of 65 and some are not suitable candiates for surgery, there is great interest in non-surgical alternatives for kidney cancer treatments. This study will investigate the use of Stereotactic Ablative Radiosurgery (SABR) for renal tumors. SABR is a non-invasive alternative, which involves delivery of high doses of radiation to the target, while minimizing the risk of injury to the surrounding organs. Patients will be seen before and end of treatmetn and will be followed at 4 month intervals for up to 2 years. During the follow ups, patients will be asked to complete a quality of life questionnaire and will have standard of care imaging.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria5

  • ≥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

Interventions

RADIATIONStereotactic Ablative Radiotherapy

Stereotactic Ablative Radiotherapy to renal tumors with a dose of 27.5-40 Gy in 5 fractions.


Locations(2)

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, Canada

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NCT03747133


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