Protocol Number: 99-C-0170

Title:

A Phase II Study to Evaluate Radiofrequency Ablation of Renal Cancer

Number:

99-C-0170

Summary:

This study will examine the safety and effectiveness of electrocautery in treating kidney cancer. Electrocautery is a non-surgical procedure that uses heat to kill the tumor. Some patients are not good surgery candidates because of age, health reasons, or the need for dialysis following surgery. Patients whose tumor cells are destroyed by electrocautery may not need surgery, or may have their surgery delayed.

Patients with kidney tumors from 0.5 to 3.0 cm in size will be screened for eligibility in the study with a history and physical examination, CT scan, chest X-ray and blood tests. Study patients will then have their tumors cauterized using a needle device approved by the Food and Drug Administration for treating soft tissues. The patient first receives a local anesthetic in the area of the back where the needle, or needles, are inserted through the skin into the tumor. (A separate needle stick may be used for each tumor treated.) After insertion, the needles are heated to 85 to 105 degrees centigrade (185 to 221 degrees Fahrenheit) for 10 minutes. A thermometer then measures the temperature of the tumor tissue. If the tumor has not been heated to 60 degrees centigrade (140 degrees Fahrenheit), it may be reheated up to two more times to reach that temperature.

Patients will be evaluated after the treatment for any complications, similar to those that may occur after surgery. From 1 to 6 months after the procedure, patients will have a CT scan of the abdomen, nuclear medicine kidney scan, and blood or urine tests to evaluate kidney function and tumor growth, if any. These tests will be repeated a year after treatment.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Ages 18 and older;

and localized renal cancer;

and creatinine less than 2.0 mg/dl or creatinine clearance greater than 60 ml/min;

and renal tumors seen to enlarge on imaging studies over a minimum of 12 months;

and tumor size between 0.5 and 3.0 cm in diameter at time of treatment.

Occasionally, RFA is anticipated for patients whose tumors are less than 3cm. We generally follow these subjects until tumor size is appropriate for the procedure. Infrequently, at follow-up, tumor size exceeds 3.0cm. In these instances, in which ablation has been planned, we will allow ablation of tumors up to 4cm. in size.

Patients may be retreated if there is initial tumor shrinkage of treated tumors or there is tumor growth of a treated tumor over at least one year or if untreated tumors grow in patients with previously treated tumors.

EXCLUSION CRITERIA:

Renal tumors smaller than 0.5 cm in diameter

or renal tumors larger than 3.0 cm in diameter

or pregnancy.

Tumors which have been awaiting ablation, and found unexpectedly at follow-up to be between 3.0cm and 4.0cm will be eligible for ablation.

Special Instructions: Currently Not Provided

Keywords:

Radiofrequency

Tumor

Ablation

Treatment

Kidney

Recruitment Keywords:

Renal Cancer

Kidney Cancer

Conditions:

Kidney Neoplasm

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

CSSC
Clinical Studies Support Center/NCI
164 Rollins Avenue
2nd FLoor
Rockville, MD 20852
Phone: (888) 624-1937
Fax: (301) 881-8239

Electronic Address: ncicssc@mail.nih.gov

Citations:

Long-term followup after nephron sparing surgery for renal cell carcinoma in von hippel-lindau disease

Conservative renal surgery for renal cell carcinoma in von hippel-lindau's disease

Parenchymal sparing surgery in patients with hereditary renal cell carcinoma

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