Stereotactic Body Proton Therapy for Treatment of Primary Renal Cell Carcinoma

NCT ID: NCT06376669

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-25
• Study Completion Date: 2030-08-31

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.

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.

Conditions

Renal Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Proton Stereotactic Body Radiation Therapy (SBRT)

The SBRT group is the single arm of this study.

Group Type: EXPERIMENTAL

Proton Stereotactic Body Radiation therapy (SBRT)

Intervention Type: RADIATION

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

Interventions

Proton Stereotactic Body Radiation therapy (SBRT)

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

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Robert L. Sloan Fund for Cancer Research

OTHER

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sherif Shaaban, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Sibley Memorial Hospital

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

Site Status: RECRUITING

Countries

United States

Central Contacts

Sherif Shaaban

Role: CONTACT

sshaaba1@jhmi.edu

202-919-2523

Ryan Manuel

Role: CONTACT

rmanuel5@jhmi.edu

410-955-4261

Facility Contacts

Sherif Shaaban

Role: primary

sshaaba1@jhmi.edu

202-919-2523

Other Identifiers

IRB00427823

Identifier Type: OTHER

Identifier Source: secondary_id

J2421

Identifier Type: -

Identifier Source: org_study_id