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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Radiation therapy will consist of 3-5 treatments over 1.5 - 2 weeks
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
RECRUITINGChange in kidney function after PROTON-BASED SBRT treatment as assessed by serum creatine levels
Change in serum creatine levels from Baseline visit.
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
Change in eGFR values from Baseline visit.
Time frame: Baseline and every 3-6 months up to 2 years post treatment
Number of PROTON-BASED SBRT treatment Adverse Events
Adverse events associated with PROTON-BASED SBRT treatment.
Time frame: 24 months post treatment
Local progression of disease after PROTON-BASED SBRT treatment as assessed by size or appearance of lesions
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 of disease after PROTON-BASED SBRT treatment as assessed by appearance of lesions
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
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: Baseline and every 3-6 months up to 2 years post treatment
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Overall survival
Overall survival (OS) is defined as the duration of time from start of treatment to the time of death from any cause.
Time frame: 24 months post treatment