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SABR for Renal Tumors

ConditionRenal Tumor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

≥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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Stereotactic Ablative Radiotherapy

    Radiation

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

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: Stereotactic Ablative RadiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
2 years

Secondary outcomes

1

Chronic Kidney Disease Stage Progression

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

Time frame
2 years
2

2-year Local recurrence rate

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

Time frame
2 years
3

Patient Reported Outcomes

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

Time frame
2 years
4

Incidence of acute and late toxicities

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.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov
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