Proton Therapy for Kidney Cancer

(SPARE Trial)

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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Proton Stereotactic Body Radiation therapy (SBRT) for kidney cancer?

Research shows that Proton Stereotactic Body Radiation Therapy (SBRT) can be safely and effectively used for kidney cancer, especially in patients who cannot undergo surgery. In one case, a patient with inoperable kidney tumors treated with proton SBRT experienced no severe side effects and maintained stable kidney function one year after treatment. ^{1 2 3 4 5}

Is proton therapy safe for treating kidney cancer?

Proton therapy, including proton stereotactic body radiation therapy (SBRT), has been used safely in humans for treating kidney cancer. Studies show that patients experienced no severe side effects, and any minor changes in kidney function were manageable without additional treatment. ^{1 2 6 7 8}

How is Proton Stereotactic Body Radiation Therapy (SBRT) unique for treating kidney cancer?

Proton Stereotactic Body Radiation Therapy (SBRT) is unique because it delivers high doses of radiation in a few sessions, which can effectively target kidney cancer cells that are usually resistant to traditional radiation. This makes it a promising option for patients who cannot undergo surgery. ^{9 10 11 12 13}

Research Team

Sherif Shaaban, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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) 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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Phase I dose-escalation study of stereotactic body radiotherapy (SBRT) for poor surgical candidates with localized renal cell carcinoma. [2022]

2. United States 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiotherapy for Renal Cell Carcinoma: Oncological and Renal Function Outcomes. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Local control rates of metastatic renal cell carcinoma (RCC) to the bone using stereotactic body radiation therapy: Is RCC truly radioresistant? [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Role of Radiation in Treatment of Renal Cell Carcinoma. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Nephron-Sparing Robotic Radiosurgical Therapy for Primary Renal Cell Carcinoma: Single-Institution Experience and Review of the Literature. [2022]

7. United States 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. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiotherapy for Frail Patients with Primary Renal Cell Carcinoma: Preliminary Results after 4 Years of Experience. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy (SBRT) on renal cell carcinoma, an overview of technical aspects, biological rationale and current literature. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Radiation therapy options in kidney cancer. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiotherapy for Localized Kidney Cancer. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Palliative Radiation Therapy for Symptomatic Control of Inoperable Renal Cell Carcinoma. [2020]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of ablative high-dose-per-fraction radiation for implanted human renal cell cancer in a nude mouse model. [2022]