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A Phase II Study to Evaluate Radiofrequency Ablation of Renal Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Kidney Cancer

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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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Localized renal cell carcinoma, meeting both of the following criteria:

- Enlarging renal tumors on imaging studies over a minimum of 12 months

- Tumor size between 0.5-4.0 cm in diameter at time of treatment

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Creatinine less than 2.0 mg/dL OR

- Creatinine clearance greater than 60 mL/min

Other:

- Not pregnant

- Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specifed

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response

Safety Issue:

No

Principal Investigator

McClellan M. Walther, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Urologic Oncology Branch

Authority:

United States: Federal Government

Study ID:

CDR0000067334

NCT ID:

NCT00019955

Start Date:

March 2000

Completion Date:

Related Keywords:

  • Kidney Cancer
  • stage I renal cell cancer
  • stage II renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182