Palliative Radiofrequency Ablation in Metastatic Renal Cell Carcinoma Patients

Phase 1

Completed

• Conditions: Carcinoma, Renal Cell
• Interventions: Procedure: Radiofrequency ablation; Interferon-alpha; Procedure: Radiofrequency ablation; Sunitinib maleate; Drug: Sunitinib maleate

• Registration Number: NCT00891475
• Lead Sponsor: Kidney Cancer Research Bureau

Brief Summary

The purpose of this study is to evaluate efficacy and safety of Radiofrequency ablation in metastatic renal cell carcinoma patients with primary tumor less than 5 cm before medical treatment. Ablation may allow for reduced morbidity and may increase the likelihood of patients receiving systemic therapy.

Detailed Description

Nephrectomy has become an integral part of the management of patients with metastatic kidney cancer. Performing nephrectomy in these patients is not without risk, however. The very real chance of significant metastatic disease progression during the postoperative period or complication before or during surgery that may prolong postoperative recovery could potentially delay or prevent the administration of systemic therapy in the postoperative period. Patient selection for surgery remains critical for success.

Radiofrequency ablation (RFA) is a medical procedure where tumor is ablated using microwave energy to treat a medical disorder. The benefits of RFA in selected metastatic renal cell carcinoma patients with small primary tumor (\<5 cm) will be evaluated in this Phase I/II study.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2009-04-30
• Study First Submitted QC: 2009-04-30
• Study First Posted: 2009-05-01
• Primary Completion: 2010-01
• Study Completion: 2011-01
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-11
• Last Update Posted: 2014-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Histologically proven renal cell carcinoma before RFA;
• Primary tumor no grater than 5 cm;
• CT-confirmed metastatic measurable sites;
• Good prognosis by adapted MSKCC criteria;
• No treatment for RCC;

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Radiofrequency ablation; Interferon-alpha	38 patients
Arm 2	Radiofrequency ablation; Sunitinib maleate	38 patients
Arm 3	Sunitinib maleate	38 patients

Primary Outcome Measures

Name	Time	Method
Progression-free survival	11 months

Secondary Outcome Measures

Name	Time	Method
Overall survival	24 months
rate of complications	1 year
time from the end of ablation to start of medical treatment	3 months
Progression-free survival	6 months
Quality of life (QOL)	6 months

Trial Locations

Locations (1)

Ilya Tsimafeyeu; 🇷🇺 Moscow, Russian Federation