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NCT Number: NCT03747133

SABR for Renal Tumors

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.

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Key information

Conditions

Renal Tumor Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location status: Recruiting

Location contact

Andrew Bayley, MD

SUB_INVESTIGATOR

Andrew McPartlin, MD

CONTACT

[email protected]

416-946-4501 ext. 4855

Andrew McPartlin, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Systemic therapy (except endocrine therapy) within 60 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

Treatment and study plan

stereotactic ablative radiotherapy

Radiation

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

Primary outcomes

  1. To evaluate the radiation induced renal impairments in patients receiving SABR.

    Time frame: 2 years

    The prevalence of nephron toxicity in patients treated with SABR, measured by the change in Glomerular Filtration Rate (GFR) every 4 months over 2 years.

Secondary outcomes

  1. Chronic Kidney Disease Stage Progression

    Time frame: 2 years

    Chronic kidney disease stage progression after SABR, assessed by the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines

  2. 2-year Local recurrence rate

    Time frame: 2 years

    2 year local recurrence rate of kidney tumors treated with SABR, measured by assessing the change of irradiated kidney function on functional imaging.

  3. Patient Reported Outcomes

    Time frame: 2 years

    The change in quality of life of patients treated with SABR, assessed through the use of NCCN FKSI-19 questionnaire.

  4. Incidence of acute and late toxicities

    Time frame: 2 years

    The incidence of acute (≤3 months) and late complication of interest (GI or GU complications, high blood pressure and adrenal insufficiency) as assessed by CTCAE version 5.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Glicksman, MD

CONTACT

[email protected]

416-946-4501 ext. 4483

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Phase II Study: Stereotactic Ablative Radiotherapy for Renal Tumors

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Nov 20, 2018
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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