PII SBRT + Microwave Ablation in Renal Cell Carcinoma

Renal cell carcinoma is traditionally managed via a surgical approach. Increasingly, local
therapy with radiofrequency and microwave ablation is being utilized as an alternative for
patients who may not tolerate a nephrectomy or who refuse one. Although local control rates
for small lesions are excellent, they drop off precipitously for lesions over 4 cm.
Furthermore, lesions in critical areas such as the renal hilum may be difficult to treat with
this method. Stereotactic body radiation therapy (SBRT) has had a long record of treating
patients with inoperable tumors in locations such as the lung and central nervous system, and
there is increasing evidence that it may be useful for patients with renal cell carcinoma.
The recent emergence of MRI-guided radiation therapy allows for direct visualization of
tumors during treatment, and may potentially allow clinicians to treat tumors more precisely.
This phase I study will treat renal cell carcinoma patients using a combination of MRI-guided
stereotactic body radiation therapy and microwave ablation.

Inclusion Criteria:

- Patients with imaging findings consistent with renal cell carcinoma

- Deemed medically inoperable per urology evaluation

- Tumor size >4cm in largest dimension

- ECOG performance status of <2

- Signed informed consent document(s)

- Patients with metastatic disease will not be excluded

Exclusion Criteria:

- Patients who fail MRI screening

- Pregnant or nursing women

- History of prior radiation therapy to the upper abdomen

- History of invasive cancer in the last 3 years (except for appropriately treated
low-rist prostate cancer, treated non-melanoma/melanoma skin cancer, appropriately
treated ductal carcinoma in situ or early stage invasive carcinoma of breast and
appropriately treated in-situ/early stage cervical/endometrial cancer)

- Treatment with a non-approved or investigational drug within 28 days of study
treatment