Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
Location status: Recruiting
NCT Number: NCT06376669
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Washington D.C., District of Columbia, 20016, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Radiation therapy will consist of 3-5 treatments over 1.5 - 2 weeks
Time frame: Baseline and every 3-6 months up to 2 years post treatment
Change in serum creatine levels from Baseline visit.
Time frame: Baseline and every 3-6 months up to 2 years post treatment
Change in eGFR values from Baseline visit.
Time frame: 24 months post treatment
Adverse events associated with PROTON-BASED SBRT treatment.
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).
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).
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.
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.
Contact information is provided by the study sponsor or research team.
Ryan Manuel
CONTACT
Sherif Shaaban
CONTACT
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Other
Prospective Phase II Study of Stereotactic Body Proton Therapy for Treatment of PrimAry Renal Cell Carcinoma (SPARE)
Acronym: SPARE
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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