Renal TumorNCT03747133
SABR for Renal Tumors
A study testing Stereotactic Ablative Radiotherapy in people with Renal Tumor, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Tumor
- What is being tested?
- Stereotactic Ablative Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2018to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- ≥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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Andrew McPartlin, MD, 416-946-4501 ext. 4855, andrew.mcpartlin@rmp.uhn.ca
Andrew McPartlin, MD
About this study
Official title: Phase II Study: Stereotactic Ablative Radiotherapy for Renal Tumors
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.
- Conditions
- Renal Tumor
- Being tested
- Stereotactic Ablative Radiotherapy
- Keywords
- Stereotactic Body Radiation Therapy, SABR, Radiation Therapy, Renal Cell Carcinoma, RCC
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Ablative RadiotherapyRadiation
Stereotactic Ablative Radiotherapy to renal tumors with a dose of 27.5-40 Gy in 5 fractions.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Ablative Radiotherapy | Experimental | Adult patients with Kidney mass (either primary or metastasis) amenable to SABR Receives: Radiation: Stereotactic Ablative Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (4)
Chronic Kidney Disease Stage Progression
Chronic kidney disease stage progression after SABR, assessed by the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start1 Nov 2018
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal TumorStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Glicksman, MD, Principal investigator, The Princess Margaret Cancer Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747133
- Sponsor's protocol ID
- 18-5481
- Status last verified
- Jun 2026
- First submitted
- 1 Nov 2018
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Glicksman RM, Winter J, McPartlin A, Santiago AT, Wang K, Bernstein J, Dang J, Tsui G, Chung P, Mesci A, Gutierrez Valencia E, Raman S, Berlin A, Catton C, Bayley A, Warde P, Krishna S, Finelli A, Hamilton RJ, Pace KT, Kitchlu A, Helou J. Stereotactic Body Radiation Therapy for Renal Tumors: A Prospective Phase 2 Clinical Trial. Int J Radiat Oncol Biol Phys. 2026 May 1;125(1):154-163. doi: 10.1016/j.ijrobp.2025.11.005. Epub 2025 Nov 23.
PubMed 41290048
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study: Stereotactic Ablative Radiotherapy for Renal Tumors
- ClinicalTrials.gov ID
- NCT03747133
- Acronym / sponsor ID
- 18-5481
- Conditions
- Renal Tumor
- Keywords
- Stereotactic Body Radiation Therapy, SABR, Radiation Therapy, Renal Cell Carcinoma, RCC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 20 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Ablative Radiotherapy | Experimental | Radiation: Stereotactic Ablative RadiotherapyAdult patients with Kidney mass (either primary or metastasis) amenable to SABR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- ≥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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Ablative RadiotherapyStereotactic Ablative Radiotherapy to renal tumors with a dose of 27.5-40 Gy in 5 fractions. | Radiation | Stereotactic Ablative Radiotherapy |
Primary outcome
To evaluate the radiation induced renal impairments in patients receiving SABR.
Time frame: 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.
4 secondary outcomes
Chronic Kidney Disease Stage Progression
Time frame: 2 years
2-year Local recurrence rate
Time frame: 2 years
Patient Reported Outcomes
Time frame: 2 years
Incidence of acute and late toxicities
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Derived from this study: PubMed 41290048Glicksman RM, Winter J, McPartlin A, Santiago AT, Wang K, Bernstein J, Dang J, Tsui G, Chung P, Mesci A, Gutierrez Valencia E, Raman S, Berlin A, Catton C, Bayley A, Warde P, Krishna S, Finelli A, Hamilton RJ, Pace KT, Kitchlu A, Helou J. Stereotactic Body Radiation Therapy for Renal Tumors: A Prospective Phase 2 Clinical Trial. Int J Radiat Oncol Biol Phys. 2026 May 1;125(1):154-163. doi: 10.1016/j.ijrobp.2025.11.005. Epub 2025 Nov 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel Glicksman, MD principal investigator
The Princess Margaret Cancer Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Ablative Radiotherapy in people with Renal Tumor, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Glicksman, MD (416-946-4501 ext. 4483, rachel.glicksman@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the radiation induced renal impairments in patients receiving SABR. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03747133, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026; AzTrials last refreshed its copy on 1 Nov 2026.