Trial Information

A Phase II Study to Evaluate Radiofrequency Ablation of Renal Cancer

OBJECTIVES:

Primary

- Evaluate the efficacy of radiofrequency interstitial tissue ablation in terms of tumor
destruction or slowed tumor growth rate in patients with localized renal cell
carcinoma.

Secondary

- Assess the toxicity of this treatment regimen in these patients.

OUTLINE: Patients undergo percutaneous radiofrequency interstitial tumor ablation (RFA).
Patients are offered laparoscopy-assisted percutaneous RFA in the operating room if their
tumors are not safely accessible. Intra-operative ultrasound is used to confirm probe
placement and to monitor treatment delivery. If the target temperature or impedance are not
reached, treatment is repeated no more than twice. No more than 5 tumors are treated per
kidney.

All patients are followed at 2 to 3 months, 6 months, and then at 1 year.

Patients with tumors greater than 2 cm in diameter are followed every 6 months for up to 5
years. Patients whose tumors become greater than 3 cm are recommended for surgery and
removed from study if surgery is performed.

PROJECTED ACCRUAL: A total of 63 patients will be accrued for this study within 1 year.