Back to resultsSABR for Renal Tumors
Primary Purpose
Renal Tumor
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Stereotactic Ablative Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Renal Tumor focused on measuring Stereotactic Body Radiation Therapy, SABR, Radiation Therapy, Renal Cell Carcinoma, RCC
Eligibility Criteria
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
Sites / Locations
- Royal Victoria Regional Health Centre
- University Health Network - Princess Margaret Cancer CentreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stereotactic Ablative Radiotherapy
Arm Description
Adult patients with Kidney mass (either primary or metastasis) amenable to SABR
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Chronic Kidney Disease Stage Progression
Chronic kidney disease stage progression after SABR, assessed by the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines
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.
Patient Reported Outcomes
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
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.
Full Information
NCT ID
NCT03747133
First Posted
November 1, 2018
Last Updated
May 7, 2023
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT03747133
Brief Title
SABR for Renal Tumors
Official Title
Phase II Study: Stereotactic Ablative Radiotherapy for Renal Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Tumor
Keywords
Stereotactic Body Radiation Therapy, SABR, Radiation Therapy, Renal Cell Carcinoma, RCC
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stereotactic Ablative Radiotherapy
Arm Type
Experimental
Arm Description
Adult patients with Kidney mass (either primary or metastasis) amenable to SABR
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Ablative Radiotherapy
Intervention Description
Stereotactic Ablative Radiotherapy to renal tumors with a dose of 27.5-40 Gy in 5 fractions.
Primary Outcome Measure Information:
Title
To evaluate the radiation induced renal impairments in patients receiving SABR.
Description
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 Outcome Measure Information:
Title
Chronic Kidney Disease Stage Progression
Description
Chronic kidney disease stage progression after SABR, assessed by the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines
Time Frame
2 years
Title
2-year Local recurrence rate
Description
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
Title
Patient Reported Outcomes
Description
The change in quality of life of patients treated with SABR, assessed through the use of NCCN FKSI-19 questionnaire.
Time Frame
2 years
Title
Incidence of acute and late toxicities
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew McPartlin, MD
Phone
416-946-4501
Ext
4855
Email
andrew.mcpartlin@rmp.uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew McPartlin, MD
Organizational Affiliation
The Princess Margaret Cancer Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Victoria Regional Health Centre
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
University Health Network - Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew McPartlin, MD
Phone
416-946-4501
Ext
4855
Email
andrew.mcpartlin@rmp.uhn.ca
First Name & Middle Initial & Last Name & Degree
Andrew McPartlin, MD
First Name & Middle Initial & Last Name & Degree
Andrew Bayley, MD
12. IPD Sharing Statement
Learn more about this trial
SABR for Renal Tumors
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