Stereotactic Body Proton Therapy for Treatment of Primary Renal Cell Carcinoma (SPARE)

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.

Study Overview

• Status: Recruiting
• Conditions: Renal Cell Carcinoma
• Intervention / Treatment: Radiation: Proton Stereotactic Body Radiation therapy (SBRT)

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sherif Shaaban; Phone Number: 202-919-2523; Email: sshaaba1@jhmi.edu
• Study Contact Backup: Name: Ryan Manuel; Phone Number: 410-955-4261; Email: rmanuel5@jhmi.edu

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20016
      • Recruiting
      • Sibley Memorial Hospital
      • Contact: Sherif Shaaban; Phone Number: 202-919-2523; Email: sshaaba1@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years
2. Biopsy proven renal cell carcinoma.
3. No clinical or radiographic evidence of metastatic disease.
4. Not a candidate for surgical treatment or local ablative procedures.
5. Subjects are able to undergo either an MRI or administration of contrast agent for CT.

Exclusion Criteria:

1. Prior history of radiation treatment with overlapping fields.
2. Patients with proven metastatic disease.
3. Female subjects who are pregnant or planning to become pregnant during the treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Proton Stereotactic Body Radiation Therapy (SBRT); The SBRT group is the single arm of this study.	Radiation: Proton Stereotactic Body Radiation therapy (SBRT); Radiation therapy will consist of 3-5 treatments over 1.5 - 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in kidney function after PROTON-BASED SBRT treatment as assessed by serum creatine levels	Change in serum creatine levels from Baseline visit.	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.	Baseline and every 3-6 months up to 2 years post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of PROTON-BASED SBRT treatment Adverse Events	Adverse events associated with PROTON-BASED SBRT treatment.	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).	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).	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.	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.	24 months post treatment

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: Robert L. Sloan Fund for Cancer Research
• Investigators: Principal Investigator: Sherif Shaaban, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: SBRT; Stereotactic Body Radiation Therapy; RCC
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Carcinoma; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: J2421; IRB00427823 (Other Identifier: JHM IRB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No