Prospective phase II study of stereotactic body proton therapy for treatment of primary renal cell carcinoma (SPARE): clinical trial protocol Article Swipe
S. Shaaban
,
Hao Chen
,
Nirmish Singla
,
Anh Tran
,
Chen Hu
,
Suqi Ke
,
Thomas W. Jarrett
,
Curtiland Deville
·
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1186/s12885-025-14486-1
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1186/s12885-025-14486-1
Background The incidence of kidney cancer diagnosis has been increasing over the last years. Surgical resection and local ablation are primary treatment options for localized disease. However, many patients are deemed medically inoperable, technically high risk for surgery or local ablation, or ultimately decline these procedures. Stereotactic body radiation therapy (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 may be associated with a significant decline in kidney function that necessitates additional intervention including dialysis in some patients. Proton therapy possesses unique properties that allow the bulk of the energy to be released at the tumor (Bragg peak) while sparing nearby healthy tissues, particularly the remaining ipsilateral and contralateral kidneys. Methods SPARE is a single arm, phase II study. Nineteen patients will be recruited and followed for 2 years. Eligible criteria include a biopsy confirmed diagnosis of primary RCC, if feasible, medically inoperable, technically high-risk patients for surgery or local ablative procedures, or decline surgery or ablation, and no clinical or radiographic evidence of metastatic disease. Radiotherapy treatment planning is undertaken using four dimensional computed tomography scanning to incorporate the impact of respiratory motion. Treatment must be delivered using a proton based SBRT using 40–42 Gy in 3–5 fractions. The primary endpoint is the change in Kidney function following proton based SBRT. The secondary endpoints are local control, toxicity profile, progression and overall survival. Discussion SPARE study represents the first trial to our knowledge evaluating the use of proton based SBRT for treatment of primary RCC. We aim to assess the efficacy and toxicity of this approach and to compare our results to historical outcomes established by previous trials. Proton therapy with its unique properties may be able to spare more ipsilateral and contralateral healthy kidney tissue, thus preserving kidney function superior to photon SBRT particularly in patients with challenging situations including patients with a solitary kidney, large tumors close to nearby organs or poor baseline kidney function. Trial registration Clinicaltrials.gov NCT06376669, registered April 19, 2024.
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- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1186/s12885-025-14486-1
- https://bmccancer.biomedcentral.com/counter/pdf/10.1186/s12885-025-14486-1
- OA Status
- gold
- Cited By
- 1
- References
- 24
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4411908463
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- OpenAlex ID
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https://openalex.org/W4411908463Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1186/s12885-025-14486-1Digital Object Identifier
- Title
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Prospective phase II study of stereotactic body proton therapy for treatment of primary renal cell carcinoma (SPARE): clinical trial protocolWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2025Year of publication
- Publication date
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2025-07-01Full publication date if available
- Authors
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S. Shaaban, Hao Chen, Nirmish Singla, Anh Tran, Chen Hu, Suqi Ke, Thomas W. Jarrett, Curtiland DevilleList of authors in order
- Landing page
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https://doi.org/10.1186/s12885-025-14486-1Publisher landing page
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https://bmccancer.biomedcentral.com/counter/pdf/10.1186/s12885-025-14486-1Direct link to full text PDF
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goldOpen access status per OpenAlex
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https://bmccancer.biomedcentral.com/counter/pdf/10.1186/s12885-025-14486-1Direct OA link when available
- Concepts
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Medicine, Renal cell carcinoma, Surgical oncology, Clinical trial, Protocol (science), Oncology, Proton therapy, Carcinoma, Internal medicine, Radiation therapy, Pathology, Alternative medicineTop concepts (fields/topics) attached by OpenAlex
- Cited by
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1Total citation count in OpenAlex
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2025: 1Per-year citation counts (last 5 years)
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10Other works algorithmically related by OpenAlex
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