Proton Therapy for Kidney Cancer

(SPARE Trial)

Recruiting at 1 trial location

Overseen By Ryan Manuel

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Disqualifiers: Metastatic disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1-2 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new radiation treatment called proton stereotactic body radiation therapy (SBRT) for individuals with kidney cancer. The main goal is to assess how this treatment affects kidney function and its effectiveness in controlling cancer locally, regionally, and throughout the body. Researchers also aim to determine if it helps patients live longer without cancer progression. Individuals with renal cell carcinoma, who are not candidates for surgery or other local treatments, might be suitable for this trial. Participants should not have cancer spread to other parts of the body and must be able to undergo certain imaging tests. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in kidney cancer treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that proton stereotactic body radiation therapy (SBRT) is safe for kidney cancer?

Research has shown that proton stereotactic body radiation therapy (SBRT) is safe for treating certain cancers, including kidney cancer. One study found that kidney function slightly decreased after a year of this treatment, but patients generally tolerated it well. Another study demonstrated that proton SBRT effectively targets cancer cells while limiting exposure to nearby organs, such as the kidneys, thereby reducing potential harm.

Early evidence also suggests that proton SBRT is a good option for patients who cannot or choose not to undergo surgery, making it a suitable alternative. Overall, these findings indicate that proton SBRT is a safe and promising treatment for kidney cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for kidney cancer, such as surgery, traditional radiation, and chemotherapy, Proton Stereotactic Body Radiation Therapy (SBRT) offers a unique delivery method by precisely targeting tumors with high doses of radiation while sparing surrounding healthy tissue. This precision is achieved through the use of proton beams, which can be controlled more accurately than the X-rays used in conventional radiation therapy. Researchers are excited about this treatment because it has the potential to reduce side effects and improve the quality of life for patients, while still effectively controlling or eliminating the cancer.

What evidence suggests that proton SBRT is effective for kidney cancer?

Research shows that Proton Stereotactic Body Radiation Therapy (SBRT), which participants in this trial will receive, effectively treats kidney cancer. Studies have found promising results, with 95% of patients surviving for at least three years and 100% remaining disease-free during that time. Proton therapy targets cancer cells more precisely, protecting the healthy tissue around the kidney. Additionally, patients have generally tolerated it well, with few significant side effects reported. This makes proton SBRT an appealing option for treating kidney cancer while minimizing harm to healthy organs. ^{1 2 3 6 7}

Who Is on the Research Team?

Sherif Shaaban, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with biopsy-proven renal cell carcinoma, which hasn't spread to other parts of the body. It's specifically for those who can't have surgery or local treatments and can undergo MRI or contrast CT scans.

Inclusion Criteria

I can have an MRI or a CT scan with contrast.

My kidney cancer was confirmed through a biopsy.

My cancer has not spread to other parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive proton-based stereotactic body radiation therapy (SBRT) for primary renal cell carcinoma

1-2 weeks

Daily visits for radiation sessions

Follow-up

Participants are monitored for changes in kidney function and disease progression

24 months

Visits every 3-6 months

What Are the Treatments Tested in This Trial?

Interventions

• Proton Stereotactic Body Radiation therapy (SBRT)

Trial Overview

The study is testing a type of targeted radiation called Proton Stereotactic Body Radiation Therapy (SBRT) to see how it affects kidney function and cancer outcomes like control of the tumor, spread, survival without progression, and overall survival.

How Is the Trial Designed?

Group I: Proton Stereotactic Body Radiation Therapy (SBRT) Experimental Treatment 1 Intervention

The SBRT group is the single arm of this study.

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

Robert L. Sloan Fund for Cancer Research

Collaborator

Trials

5

Recruited

70+

Robert L. Sloan Fund for Cancer Research

Collaborator

Trials

5

Recruited

70+

Published Research Related to This Trial

Stereotactic body radiation therapy (SBRT) shows over 95% local control for primary renal cell carcinoma (RCC) with limited grade 3-4 toxicity at ≤5%, indicating it is a highly effective and safe treatment option.

For metastatic RCC, SBRT achieves approximately 90% local control at one year, with an even lower incidence of grade 3-4 toxicity at around 1%, suggesting its potential as a preferred treatment method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation therapy options in kidney cancer. Zaorsky, NG., Louie, AV., Siva, S.[2023]

In a phase 1 study involving 13 patients with primary renal cell carcinoma, the maximum tolerated dose of stereotactic body radiation therapy (SBRT) was determined to be 12 Gy given in 4 fractions, with no dose-limiting toxicities observed.

After 24 months of follow-up, patients experienced no significant renal function decline, and while two patients showed a partial response, the majority maintained stable disease, indicating the treatment's safety and potential efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Stereotactic Ablative Radiation Therapy for Renal Cell Cancer: 24-Month Results of the RSR1 Phase 1 Dose Escalation Study. Lapierre, A., Badet, L., Rouviere, O., et al.[2023]

In a study of 21 patients with stage I renal cancer treated with stereotactic body radiation therapy (SBRT), the local tumor control rate was an impressive 100% at 5 years, indicating high efficacy of this noninvasive treatment.

The treatment resulted in only minimal toxicity, with only three patients experiencing grade 1 side effects, suggesting that SBRT is a safe option for patients, especially those who refuse surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nephron-Sparing Robotic Radiosurgical Therapy for Primary Renal Cell Carcinoma: Single-Institution Experience and Review of the Literature. Peddada, AV., Anderson, D., Blasi, OC., et al.[2022]

Proton stereotactic body radiation therapy (SBRT) was successfully used to treat a 47-year-old female patient with inoperable bilateral renal cell carcinoma (RCC), demonstrating its potential as a safe and effective treatment option for complex cases.

The patient experienced minimal acute side effects and maintained her renal function with only a slight decline in glomerular filtration rate (GFR) one year post-treatment, suggesting that proton therapy can preserve kidney function while effectively targeting tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Ever Use of Proton Stereotactic Body Radiation Therapy Delivered with Curative Intent to Bilateral Synchronous Primary Renal Cell Carcinomas. Frick, MA., Chhabra, AM., Lin, L., et al.[2023]

Stereotactic body radiotherapy (SBRT) for localized renal cell carcinoma (RCC) was well-tolerated in 19 patients aged 59-89, with no dose-limiting toxicities observed at doses up to 48Gy in 4 fractions.

Among the patients treated, 3 showed a partial response and 12 had stable disease, indicating that SBRT can be an effective treatment option for patients who are poor surgical candidates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I dose-escalation study of stereotactic body radiotherapy (SBRT) for poor surgical candidates with localized renal cell carcinoma. Ponsky, L., Lo, SS., Zhang, Y., et al.[2022]

Stereotactic body radiotherapy (SBRT) demonstrated high local control rates (96%) and overall survival (83%) in a study of 23 frail patients with primary renal cell carcinoma (RCC) who were unfit for surgery, with a median follow-up of 22 months.

The treatment was well-tolerated, with no severe side effects (grade 3-4) reported, indicating that SBRT is a safe and effective alternative for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiotherapy for Frail Patients with Primary Renal Cell Carcinoma: Preliminary Results after 4 Years of Experience. Grelier, L., Baboudjian, M., Gondran-Tellier, B., et al.[2021]

Stereotactic body radiation therapy (SBRT) has been shown to be a safe and effective treatment for localized kidney cancers, achieving over 90% local control with minimal severe toxicity in patients who are not candidates for surgery.

Recent studies indicate that SBRT can effectively treat larger kidney tumors (greater than 5 cm), but further randomized clinical trials are needed to optimize treatment protocols and compare its outcomes to traditional surgical methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiotherapy for Localized Kidney Cancer. Rich, BJ., Noy, MA., Dal Pra, A.[2023]

In a study of 74 patients with localized renal cell carcinoma treated with stereotactic body radiotherapy (SBRT), the oncological outcomes were promising, with low rates of local failure (7.77% at 4 years) and distant metastasis (4.24% at 2 years).

However, there was a notable decline in renal function over time, with a median decrease in estimated glomerular filtration rate (eGFR) of -11.5 ml/min at 2 years, particularly in the treated kidney, while the contralateral kidney showed compensatory improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiotherapy for Renal Cell Carcinoma: Oncological and Renal Function Outcomes. Glicksman, RM., Cheung, P., Korol, R., et al.[2023]

Citations

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sciencedirect.com

sciencedirect.com/science/article/pii/S2331518025004755

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thegreenjournal.com/article/S0167-8140(24)00138-5/fulltext

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The primary endpoint is the change in Kidney function following proton based SBRT. The secondary endpoints are local control, toxicity profile, progression and ...

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pmc.ncbi.nlm.nih.gov

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Proton-based SBRT may be safe and effective in treating patients with renal cell carcinoma who are not eligible for or refuse surgery. Eligibility Criteria ...