SABR for Renal Tumors

University Health Network, Toronto90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Tumor

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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-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

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

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

SABR for Renal Tumors

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts