Renal Cell CarcinomaPhase 2SPARENCT06376669
Stereotactic Body Proton Therapy for Treatment of Primary Renal Cell Carcinoma
A Phase 2 study testing Proton Stereotactic Body Radiation therapy (SBRT) in people with Renal Cell Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
This study examines the impact of proton based stereotactic radiation therapy (SBRT) on kidney function as well as other oncologic outcomes including local control, locoregional and systemic failure, progression free and overall survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Proton Stereotactic Body Radiation therapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2025to Aug 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Biopsy proven renal cell carcinoma.
- No clinical or radiographic evidence of metastatic disease.
- Not a candidate for surgical treatment or local ablative procedures.
- Subjects are able to undergo either an MRI or administration of contrast agent for CT.
Who cannot join
- Prior history of radiation treatment with overlapping fields.
- Patients with proven metastatic disease.
- Female subjects who are pregnant or planning to become pregnant during the treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Sherif Shaaban, 202-919-2523, sshaaba1@jhmi.edu
About this study
Official title: Prospective Phase II Study of Stereotactic Body Proton Therapy for Treatment of PrimAry Renal Cell Carcinoma (SPARE)
This study examines the impact of proton based stereotactic radiation therapy (SBRT) on kidney function as well as other oncologic outcomes including local control, locoregional and systemic failure, progression free and overall survival.
Read the detailed description
The incidence of kidney cancer diagnosis has been increasing over the last years. Surgical resection represents the mainstay treatment. However, many patients are deemed unfit for surgery due to medical comorbidities or technical limitations. There are non-surgical options including active surveillance, cryotherapy, microwave ablation, radiofrequency and stereotactic radiation therapy (SBRT). SBRT using conventional x-rays has recently been shown to improve outcomes for patients with primary renal cell carcinoma (RCC) in terms of local control and toxicity. However, this treatment was associated with a significant decline in kidney function that necessitates additional intervention including dialysis in some patients. Proton therapy represents an emerging technique with unique properties that allow the bulk of the proton cancer fighting energy to be released at the tumor (Bragg peak) while sparing nearby healthy tissues and organs, particularly the remaining healthy kidney, ipsilateral kidney, bowels, spine and liver. With this technology, both kidneys, the remaining ipsilateral and contralateral, could be spared and thus less damage is expected. This study aims to study the impact of proton based SBRT on the kidney function.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Proton Stereotactic Body Radiation therapy (SBRT)
- Keywords
- Stereotactic Body Radiation Therapy, SBRT, 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.
Proton Stereotactic Body Radiation therapy (SBRT)Radiation
Radiation therapy will consist of 3-5 treatments over 1.5 - 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Proton Stereotactic Body Radiation Therapy (SBRT) | Experimental | The SBRT group is the single arm of this study. Receives: Radiation: Proton Stereotactic Body Radiation therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in kidney function after PROTON-BASED SBRT treatment as assessed by serum creatine levels
Change in serum creatine levels from Baseline visit.
Measured: Baseline and every 3-6 months up to 2 years post treatment
Change in kidney function after PROTON-BASED SBRT treatment as assessed by estimated glomerular rate (eGFR) values
Change in eGFR values from Baseline visit.
Measured: Baseline and every 3-6 months up to 2 years post treatment
Secondary outcomes (5)
Number of PROTON-BASED SBRT treatment Adverse Events
Adverse events associated with PROTON-BASED SBRT treatment.
Measured: 24 months post treatment
Local progression of disease after PROTON-BASED SBRT treatment as assessed by size or appearance of lesions
Local progression is defined as an increased size of the primary lesion or appearance of a new lesion in the kidney (within the radiation field).
Measured: Baseline and every 3-6 months up to 2 years post treatment
Systemic progression of disease after PROTON-BASED SBRT treatment as assessed by appearance of lesions
Systemic progression is defined as appearance of new lesions outside the radiation field (away from the primary tumor).
Measured: Baseline and every 3-6 months up to 2 years post treatment
Time to locoregional progression
Time to locoregional progression is defined as time from the date of first SBRT PROTON-BASED SBRT fraction to date of locoregional progression, according to RECIST v1.1 criteria.
Measured: Baseline and every 3-6 months up to 2 years post treatment
Overall survival
Overall survival (OS) is defined as the duration of time from start of treatment to the time of death from any cause.
Measured: 24 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start25 Feb 2025
- Primary completionJun 2027 (estimated)
- Study completionAug 2030 (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 Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Robert L. Sloan Fund for Cancer Research
- Responsible party
- Sponsor
- Investigators
- Sherif Shaaban, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376669
- Sponsor's protocol ID
- J2421
- Other IDs
- IRB00427823
- Acronym
- SPARE
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2024
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shaaban SG, Chen H, Singla N, Tran A, Hu C, Ke S, Jarrett TW, Deville C. Prospective phase II study of stereotactic body proton therapy for treatment of primary renal cell carcinoma (SPARE): clinical trial protocol. BMC Cancer. 2025 Jul 1;25(1):1107. doi: 10.1186/s12885-025-14486-1.
PubMed 40597914
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phase II Study of Stereotactic Body Proton Therapy for Treatment of PrimAry Renal Cell Carcinoma (SPARE)
- ClinicalTrials.gov ID
- NCT06376669
- Acronym / sponsor ID
- SPARE / J2421
- Conditions
- Renal Cell Carcinoma
- Keywords
- Stereotactic Body Radiation Therapy, SBRT, RCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Robert L. Sloan Fund for Cancer Research
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 19 Apr 2024 (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.
This study examines the impact of proton based stereotactic radiation therapy (SBRT) on kidney function as well as other oncologic outcomes including local control, locoregional and systemic failure, progression free and overall survival.
Detailed description
The incidence of kidney cancer diagnosis has been increasing over the last years. Surgical resection represents the mainstay treatment. However, many patients are deemed unfit for surgery due to medical comorbidities or technical limitations. There are non-surgical options including active surveillance, cryotherapy, microwave ablation, radiofrequency and stereotactic radiation therapy (SBRT). SBRT using conventional x-rays has recently been shown to improve outcomes for patients with primary renal cell carcinoma (RCC) in terms of local control and toxicity. However, this treatment was associated with a significant decline in kidney function that necessitates additional intervention including dialysis in some patients. Proton therapy represents an emerging technique with unique properties that allow the bulk of the proton cancer fighting energy to be released at the tumor (Bragg peak) while sparing nearby healthy tissues and organs, particularly the remaining healthy kidney, ipsilateral kidney, bowels, spine and liver. With this technology, both kidneys, the remaining ipsilateral and contralateral, could be spared and thus less damage is expected. This study aims to study the impact of proton based SBRT on the kidney function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proton Stereotactic Body Radiation Therapy (SBRT) | Experimental | Radiation: Proton Stereotactic Body Radiation therapy (SBRT)The SBRT group is the single arm of this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Biopsy proven renal cell carcinoma.
- No clinical or radiographic evidence of metastatic disease.
- Not a candidate for surgical treatment or local ablative procedures.
- Subjects are able to undergo either an MRI or administration of contrast agent for CT.
Key exclusion criteria (3 listed)
- Prior history of radiation treatment with overlapping fields.
- Patients with proven metastatic disease.
- Female subjects who are pregnant or planning to become pregnant during the treatment.
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 |
|---|---|---|
| Proton Stereotactic Body Radiation therapy (SBRT)Radiation therapy will consist of 3-5 treatments over 1.5 - 2 weeks | Radiation | Proton Stereotactic Body Radiation Therapy (SBRT) |
Primary outcome
Change in kidney function after PROTON-BASED SBRT treatment as assessed by serum creatine levels
Time frame: Baseline and every 3-6 months up to 2 years post treatment
Change in serum creatine levels from Baseline visit.
Change in kidney function after PROTON-BASED SBRT treatment as assessed by estimated glomerular rate (eGFR) values
Time frame: Baseline and every 3-6 months up to 2 years post treatment
Change in eGFR values from Baseline visit.
5 secondary outcomes
Number of PROTON-BASED SBRT treatment Adverse Events
Time frame: 24 months post treatment
Local progression of disease after PROTON-BASED SBRT treatment as assessed by size or appearance of lesions
Time frame: Baseline and every 3-6 months up to 2 years post treatment
Systemic progression of disease after PROTON-BASED SBRT treatment as assessed by appearance of lesions
Time frame: Baseline and every 3-6 months up to 2 years post treatment
Time to locoregional progression
Time frame: Baseline and every 3-6 months up to 2 years post treatment
Overall survival
Time frame: 24 months post treatment
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 3 Apr 2026.
- Derived from this study: PubMed 40597914Shaaban SG, Chen H, Singla N, Tran A, Hu C, Ke S, Jarrett TW, Deville C. Prospective phase II study of stereotactic body proton therapy for treatment of primary renal cell carcinoma (SPARE): clinical trial protocol. BMC Cancer. 2025 Jul 1;25(1):1107. doi: 10.1186/s12885-025-14486-1.
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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.
Sherif Shaaban, MD principal investigator
Johns Hopkins University
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 Proton Stereotactic Body Radiation therapy (SBRT) in people with Renal Cell Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 5 inclusion and 3 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 3 Apr 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 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?
Contact Sherif Shaaban (202-919-2523, sshaaba1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in kidney function after PROTON-BASED SBRT treatment as assessed by serum creatine levels (time frame: Baseline and every 3-6 months up to 2 years post treatment). The study lists 2 primary outcomes in all. 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 NCT06376669, 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 3 Apr 2026.