Recruiting
Phase 2

Stereotactic Body Proton Therapy

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Code:

NCT06376669

Conditions

Renal Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Proton Stereotactic Body Radiation therapy (SBRT)

Study Details

Brief summary:

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.

Conditions

Renal Cell Carcinoma

Study ID

NCT06376669

Start date

Feb 25, 2025

Status verified date

Apr, 2026

Completion date

Aug, 2030

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Proton Stereotactic Body Radiation Therapy (SBRT)

The SBRT group is the single arm of this study.

Interventions

Proton Stereotactic Body Radiation therapy (SBRT)

Radiation therapy will consist of 3-5 treatments over 1.5 - 2 weeks

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Sherif Shaaban

202-919-2523sshaaba1@jhmi.edu

Ryan Manuel

410-955-4261rmanuel5@jhmi.edu

Locations

Sibley Memorial Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20016

Contacts

Sherif Shaaban

202-919-2523sshaaba1@jhmi.edu

More Information

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Last update posted

Apr 3, 2026

Last verified

Apr, 2026

Keywords

  • Stereotactic Body Radiation Therapy
  • SBRT
  • RCC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins on 2026-04-03.