To Evaluate Stereotactic Body Radiotherapy for Treatment of Primary Renal Cell Carcinoma Tumors

Stopped early · Phase 1

Conditions studied: Primary Tumor, Renal Cell Carcinoma

In brief

The purpose of this study is to evaluate the safety and efficacy of the use of stereotactic body radiotherapy (SBRT) for the treatment of the primary tumor in renal cell carcinoma (RCC) in medically inoperable patients and/or patients who refuse surgery. Standard treatment of RCC is surgery. A number of non-surgical treatments of RCC are also available, but are highly invasive and are associated with significant side effects. SBRT is a non-invasive, non-surgical treatment that requires tumor immobilization and image guidance in order to deliver a very precise, high-dose treatment. This trial will assess the use of SBRT to treat primary renal tumors by determining the maximum tolerated dose and toxicity. Subjects enrolled in this study will then be followed and evaluated for toxicity, serum chemistry, complete blood count, and urinalysis. In addition, they will undergo renal scans to assess the functionality of their renal tissue.

Key facts

Study ID

NCT02410174

Run by

Beth Israel Medical Center

People needed

3

Starts

2012-05-01

Expected to finish

2016-12-01

Last updated by the study team

2017-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Any patient with a primary renal cell carcinoma (RCC) tumor who is inoperable for technical (i.e surgical) or medical reasons
• Patient must be screened by a urologic surgeon to verify eligibility on the above basis
• Biopsy proof of RCC is preferred; however, in current practice the diagnosis is often clinical based on characteristic imaging. If there are compelling clinical reasons not to proceed with biopsy, the clinical diagnosis will suffice.
• Patient with metastases are eligible if in the opinion of the treating physicians the patient could benefit from treatment of the primary renal tumor.
• ECOG performance status 0-2
• Age ≥18 years
• Signed informed consent

You may not qualify if…

• Inadequate renal function, as measured by creatinine clearance calculated from 24 hour urine collection. Creatinine clearance values of at least 50 ml/min are required
• Prior attempt at curative treatment of this primary kidney tumor
• Inability to lie still for approximately 1 hour in immobilization device
• Presence of a connective tissue disorder other than rheumatoid arthritis.
• Pregnancy
• Inability to develop a radiation treatment plan that adheres to the dose constraints described below in Radiotherapy Treatment Planning section.

Where it is running

• Mount Sinai Beth Israel Hospital — New York, New York, United States
• Mount Sinai Roosevelt Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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