SABR for Renal Tumors

Not Applicable

Recruiting

• Conditions: Renal Tumor
• Interventions: Radiation: Stereotactic Ablative Radiotherapy

• Registration Number: NCT03747133
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2018-11-01
• Study First Submitted QC: 2018-11-15
• Study First Posted: 2018-11-20
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stereotactic Ablative Radiotherapy	Stereotactic Ablative Radiotherapy	Adult patients with Kidney mass (either primary or metastasis) amenable to SABR

Primary Outcome Measures

Name	Time	Method
To evaluate the radiation induced renal impairments in patients receiving SABR.	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 Outcome Measures

Name	Time	Method
Chronic Kidney Disease Stage Progression	2 years	Chronic kidney disease stage progression after SABR, assessed by the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines
Patient Reported Outcomes	2 years	The change in quality of life of patients treated with SABR, assessed through the use of NCCN FKSI-19 questionnaire.
Incidence of acute and late toxicities	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.
2-year Local recurrence rate	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.

Trial Locations

Locations (2)

University Health Network - Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada

Royal Victoria Regional Health Centre; 🇨🇦 Barrie, Ontario, Canada