Renal CancersPhase 2NCT02141919
Stereotactic Ablative Body Radiation Therapy for Patients With Primary Renal Cancer
A Phase 2 study testing Stereotactic Ablative Radiation Therapy in people with Renal Cancers, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The goal of this phase II clinical trial is to evaluate the efficacy of the completely non-invasive treatment option of stereotactic radiation therapy for the treatment of biopsy proven and growing small renal tumors. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Renal Cancers
- What is being tested?
- Stereotactic Ablative Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jun 2026
- Phase
- Phase 2
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Renal mass ≤ 5cm
- The treating renal mass must be ≤ 5cm. Other renal masses (cysts etc.) of any size will not make the subject ineligible
- Biopsy proven Renal neoplasm
- All histology of renal cancers are included including oncocytoma
- Growth of renal mass >2mm in radiographic scans must be demonstrated within a one year period.
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- Ability to understand and the willingness to sign a written informed consent.
- Subject is able to undergo either an MRI or administration of contrast agent for CT
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
Who cannot join
- Subject has received any treatment for the treating renal mass; such as RFA or cyroablation.
- If other renal masses received RFA or cryoablation or surgery, then these patients are eligible.
- Subjects received previous abdominal radiation
- Evidence of Metastatic Disease, unless disease-free for ≥ 3 years prior to registration, (non-melanomatous skin cancer and in-situ cancers are okay).
- Female subjects who are pregnant or planning to become pregnant during the course of SABR.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern
Dallas, Texas, 75239
About this study
Official title: A Phase II Trial of Stereotactic Ablative Body Radiation Therapy (SABR) for Patients With Primary Renal Cancer (RCC)
The goal of this phase II clinical trial is to evaluate the efficacy of the completely non-invasive treatment option of stereotactic radiation therapy for the treatment of biopsy proven and growing small renal tumors.
Read the detailed description
Current treatment options for primary renal cancer include surgery or ablative techniques-all are invasive or minimally invasive options. The completely noninvasive treatment option of stereotactic radiation therapy (SABR), which has become standard of care in many cancer sites, has not been explored for primary renal cancer. With multiple technological advances, it is now feasible to safely treat a moving intra-abdominal tumor such as that in a kidney. This proposed clinical trial evaluates the efficacy of SABR in treating patients with early renal cancers. Growing renal masses will first be biopsied to confirm the diagnosis of renal cancer. Patients will then undergo treatment with SABR of 3-5 fractions completing within three weeks. Treatment response will be evaluated using sequential MRI scans and a second tumor biopsy one year after treatment. Monitoring of treatment toxicity and kidney function will also be performed.
- Conditions
- Renal Cancers
- Being tested
- Stereotactic Ablative Radiation Therapy
- Keywords
- renal cancer
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Ablative Radiation TherapyRadiation
Also called SABR
Stereotactic Ablative Body Radiation Therapy (SABR): 3 fractions of 12Gy, or 4 fractions of 10Gy or 5 fractions of 8 Gy
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Ablative Radiation Therapy | Experimental | Stereotactic Ablative Radiation Therapy (SABR) Receives: Radiation: Stereotactic Ablative Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eliminate its growth and tumor viability.
To evaluate if SABR to small renal tumors is able to eliminate its growth and viable tumor.
Measured: 2 years
Secondary outcomes (5)
Adverse events
To describe the adverse events associated with the administration of SABR to renal tumors.
Measured: 2 years
growth rate of renal tumors
To measure the growth rate of renal tumors after SABR treatment.
Measured: 2 years
Renal function
To measure the changes in kidney function, creatinine levels, renal perfusion and GFR after SABR treatment
Measured: 2 years
Tumor Viability
To measure tumor viability pathologically one year after SABR treatment with biopsy.
Measured: one year
progression of disease
To assess radiographic changes to the renal tumor after SABR treatment including tumor viability, enhancement necrosis,T2 tumor cellularity with diffusion-weighted imaging. To assess local, regional and systemic progression of disease after SABR to SRM .To assess time to progression (TTP) of disease from the first SABR treatment.
To assess progression free survival (PFS). PFS is defined as the length of time from start of treatment to the time of loco-regional disease progression or death from any cause.
To assess overall survival (OS). OS is defined as the duration of time from start of treatment to the time of death from any cause.
To assess tumor growth, local failure and indeterminate disease response (IDR).
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 May 2014 (estimated)
- Study startJun 2013
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CancersStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raquibul Hannan, University of Texas Southwestern Medical Center
- Investigators
- Raquibul Hannan, MD, PhD, Principal investigator, UTSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141919
- Sponsor's protocol ID
- STU 122013-030
- Status last verified
- Dec 2025
- First submitted
- 12 May 2014
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Stereotactic Ablative Body Radiation Therapy (SABR) for Patients With Primary Renal Cancer (RCC)
- ClinicalTrials.gov ID
- NCT02141919
- Acronym / sponsor ID
- STU 122013-030
- Conditions
- Renal Cancers
- Keywords
- renal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 20 May 2014 (estimated)
- 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.
The goal of this phase II clinical trial is to evaluate the efficacy of the completely non-invasive treatment option of stereotactic radiation therapy for the treatment of biopsy proven and growing small renal tumors.
Detailed description
Current treatment options for primary renal cancer include surgery or ablative techniques-all are invasive or minimally invasive options. The completely noninvasive treatment option of stereotactic radiation therapy (SABR), which has become standard of care in many cancer sites, has not been explored for primary renal cancer. With multiple technological advances, it is now feasible to safely treat a moving intra-abdominal tumor such as that in a kidney. This proposed clinical trial evaluates the efficacy of SABR in treating patients with early renal cancers. Growing renal masses will first be biopsied to confirm the diagnosis of renal cancer. Patients will then undergo treatment with SABR of 3-5 fractions completing within three weeks. Treatment response will be evaluated using sequential MRI scans and a second tumor biopsy one year after treatment. Monitoring of treatment toxicity and kidney function will also be performed.
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 Radiation Therapy | Experimental | Radiation: Stereotactic Ablative Radiation TherapyStereotactic Ablative Radiation Therapy (SABR) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years.
- Renal mass ≤ 5cm
- Biopsy proven Renal neoplasm
- Growth of renal mass >2mm in radiographic scans must be demonstrated within a one year period.
- Ability to understand and the willingness to sign a written informed consent.
Key exclusion criteria (5 listed)
- Subject has received any treatment for the treating renal mass; such as RFA or cyroablation.
- Subjects received previous abdominal radiation
- Evidence of Metastatic Disease, unless disease-free for ≥ 3 years prior to registration, (non-melanomatous skin cancer and in-situ cancers are okay).
- Female subjects who are pregnant or planning to become pregnant during the course of SABR.
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 Radiation TherapyAlso: SABRStereotactic Ablative Body Radiation Therapy (SABR): 3 fractions of 12Gy, or 4 fractions of 10Gy or 5 fractions of 8 Gy | Radiation | Stereotactic Ablative Radiation Therapy |
Primary outcome
Eliminate its growth and tumor viability.
Time frame: 2 years
To evaluate if SABR to small renal tumors is able to eliminate its growth and viable tumor.
5 secondary outcomes
Adverse events
Time frame: 2 years
growth rate of renal tumors
Time frame: 2 years
Renal function
Time frame: 2 years
Tumor Viability
Time frame: one year
progression of disease
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 26 Dec 2025.
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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. This study is not recruiting at the moment.
Raquibul Hannan, MD, PhD principal investigator
UTSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic Ablative Radiation Therapy in people with Renal Cancers, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 12 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: under way, not looking for participants, as of the sponsor's last update on 26 Dec 2025. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eliminate its growth and tumor viability. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Dec 2025.