Stereotactic Body Proton Therapy for Treatment of Primary Renal Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Proton Stereotactic Body Radiation therapy (SBRT).
- Who it may be relevant to
- Registry conditions: Renal Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Phase II Study of Stereotactic Body Proton Therapy for Treatment of PrimAry Renal Cell Carcinoma (SPARE)
Overview
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.
Interventions
- Radiation Proton Stereotactic Body Radiation therapy (SBRT)
Radiation therapy will consist of 3-5 treatments over 1.5 - 2 weeks
Primary outcome measures
- 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 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]
Secondary outcome measures (5)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Sibley Memorial Hospital — Washington D.C.
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. PMID 40597914
Identifiers
NCT: NCT06376669 · J2421 · IRB00427823