Stereotactic Body Proton Therapy for Treatment of Primary Renal Cell Carcinoma

Phase 2

Recruiting

• Conditions: Renal Cell Carcinoma
• Interventions: Radiation: Proton Stereotactic Body Radiation therapy (SBRT)

• Registration Number: NCT06376669
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Study Timeline

• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-18
• Study First Posted: 2024-04-19
• Study Start: 2025-02-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26
• Primary Completion: 2027-06
• Study Completion: 2030-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Proton Stereotactic Body Radiation Therapy (SBRT)	Proton Stereotactic Body Radiation therapy (SBRT)	The SBRT group is the single arm of this study.

Primary Outcome Measures

Name	Time	Method
Change in kidney function after PROTON-BASED SBRT treatment as assessed by serum creatine levels	Baseline and every 3-6 months up to 2 years post treatment	Change in serum creatine levels from Baseline visit.
Change in kidney function after PROTON-BASED SBRT treatment as assessed by estimated glomerular rate (eGFR) values	Baseline and every 3-6 months up to 2 years post treatment	Change in eGFR values from Baseline visit.

Secondary Outcome Measures

Name	Time	Method
Systemic progression of disease after PROTON-BASED SBRT treatment as assessed by appearance of lesions	Baseline and every 3-6 months up to 2 years post treatment	Systemic progression is defined as appearance of new lesions outside the radiation field (away from the primary tumor).
Time to locoregional progression	Baseline and every 3-6 months up to 2 years post treatment	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.
Local progression of disease after PROTON-BASED SBRT treatment as assessed by size or appearance of lesions	Baseline and every 3-6 months up to 2 years post treatment	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).
Number of PROTON-BASED SBRT treatment Adverse Events	24 months post treatment	Adverse events associated with PROTON-BASED SBRT treatment.
Overall survival	24 months post treatment	Overall survival (OS) is defined as the duration of time from start of treatment to the time of death from any cause.

Trial Locations

Locations (1)

Sibley Memorial Hospital; 🇺🇸 Washington, District of Columbia, United States