Viewing Study NCT00019955



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Study NCT ID: NCT00019955
Status: COMPLETED
Last Update Posted: 2015-04-29
First Post: 2001-07-11

Brief Title: Radiofrequency Interstitial Tissue Ablation in Treating Patients With Localized Renal Cell Carcinoma Kidney Cancer
Sponsor: National Cancer Institute NCI
Organization: National Cancer Institute NCI

Study Overview

Official Title: A Phase II Study to Evaluate Radiofrequency Ablation of Renal Cancer
Status: COMPLETED
Status Verified Date: 2005-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: RATIONALE Radiofrequency interstitial tissue ablation may kill tumor cells by heating tumors to several degrees above body temperature

PURPOSE This phase II trial is studying radiofrequency interstitial tissue ablation to see how well it works in treating patients with localized renal cell carcinoma kidney cancer
Detailed Description: 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

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
Secondary ID Type Domain Link
NCI-99-C-0170 None None None