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Proton-Based Stereotactic Body Radiation Therapy for the Treatment of Renal Cell Cancer in Patients not Undergoing Surgery
Trial Status: active
This clinical trial studies the side effects of proton-based stereotactic body radiation therapy (SBRT) and to see how well it works in treating patients with renal cell carcinoma who are not eligible for or refuse surgery. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Photon (X-ray) based SBRT interest and use has substantially increased over the last few years. However, there is concern about the long-term impact on kidney function. In proton-based SBRT, a proton beam is used to deliver the radiation. Data from other studies have shown that protons help to precisely target the tumor while sparing the normal structures around the tumor when compared to traditional X-ray based SBRT. Proton-based SBRT may be safe and effective in treating patients with renal cell carcinoma who are not eligible for or refuse surgery.
Inclusion Criteria
Age ≥ 18 years
Biopsy proven renal cell carcinoma (RCC), if feasible. In patients where biopsy is not feasible or equivocal, a Sestamibi single photon emission computed tomography (SPECT) scan is required to rule out other renal lesions and thus confirm diagnosis of RCC
Medically inoperable, technically high risk for surgery or local ablative procedures, or decline surgery or ablation
Subjects are able to undergo either a CT or MRI abdomen
No clinical or radiographic evidence of metastatic disease
Provide written informed consent
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
Patients with end-stage renal disease (ESRD) defined as GFR (glomerular filtration rate) of less than 15 ml/min
Additional locations may be listed on ClinicalTrials.gov for NCT06376669.
I. To measure the changes in kidney function after proton-based SBRT treatment.
SECONDARY OBJECTIVES:
I. To describe the adverse events associated with proton-based SBRT treatment.
II. To evaluate if proton-based SBRT is able to eliminate the growth of the tumor.
III. To assess local, regional and systemic progression of disease after proton-based SBRT.
IV. To assess time to progression (TTP) of disease from the first proton-based SBRT treatment.
V. To assess progression free survival (PFS).
VI. To assess overall survival (OS).
OUTLINE:
Patients undergo proton-based SBRT over 1 hour every other day for 3-5 treatment fractions over 1.5-2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, computed tomography (CT) and/or magnetic resonance imaging (MRI), and renal perfusion scans throughout the study. Patients may also undergo renal lesion biopsy during screening.
After completion of study treatment, patients are followed up at months 3, 6, 9, 12, 18, and 24.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
