SABR for Renal Tumors

Renal Tumor Clinical Trial

Official title:

Phase II Study: Stereotactic Ablative Radiotherapy for Renal Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03747133
• Other study ID #: 18-5481
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: November 2024

Study information

• Verified date: May 2023
• Source: University Health Network, Toronto
• Contact: Andrew McPartlin, MD
• Phone: 416-946-4501
• Email: andrew.mcpartlin[@]rmp.uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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
• 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

Related Conditions & MeSH terms

• Kidney Neoplasms
• Renal Tumor

Intervention

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

Locations

Country	Name	City	State
Canada	Royal Victoria Regional Health Centre	Barrie	Ontario
Canada	University Health Network - Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	Chronic Kidney Disease Stage Progression	Chronic kidney disease stage progression after SABR, assessed by the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines	2 years
Secondary	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.	2 years
Secondary	Patient Reported Outcomes	The change in quality of life of patients treated with SABR, assessed through the use of NCCN FKSI-19 questionnaire.	2 years
Secondary	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.	2 years