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NCT Number: NCT06376669

Stereotactic Body Proton Therapy for Treatment of Primary Renal Cell Carcinoma

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sibley Memorial Hospital

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

Location status: Recruiting

Location contact

Sherif Shaaban

CONTACT

[email protected]

202-919-2523

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Proton Stereotactic Body Radiation therapy (SBRT)

Radiation

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

Primary outcomes

  1. 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 serum creatine levels from Baseline visit.

  2. 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

    Change in eGFR values from Baseline visit.

Secondary outcomes

  1. Number of PROTON-BASED SBRT treatment Adverse Events

    Time frame: 24 months post treatment

    Adverse events associated with PROTON-BASED SBRT treatment.

  2. Local progression of disease after PROTON-BASED SBRT treatment as assessed by size or appearance of lesions

    Time frame: 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).

  3. Systemic progression of disease after PROTON-BASED SBRT treatment as assessed by appearance of lesions

    Time frame: 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).

  4. Time to locoregional progression

    Time frame: 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.

  5. Overall survival

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ryan Manuel

CONTACT

[email protected]

410-955-4261

Sherif Shaaban

CONTACT

[email protected]

202-919-2523

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • Robert L. Sloan Fund for Cancer Research

Registry information

Official study title

Prospective Phase II Study of Stereotactic Body Proton Therapy for Treatment of PrimAry Renal Cell Carcinoma (SPARE)

Acronym: SPARE

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Apr 19, 2024
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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