Palliative Radiofrequency Ablation in Metastatic Renal Cell Carcinoma Patients - Full Text View

Sponsor:	Kidney Cancer Research Bureau
Information provided by:	Kidney Cancer Research Bureau
ClinicalTrials.gov Identifier:	NCT00891475

Purpose

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.

Condition	Intervention	Phase
Carcinoma, Renal Cell	Procedure: Radiofrequency ablation; Interferon-alpha Procedure: Radiofrequency ablation; Sunitinib maleate Drug: Sunitinib maleate	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Trial of Palliative Radiofrequency Ablation in Metastatic Renal Cell Carcinoma Patients With Small Primary Tumor

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Interferon Interferon alfa-2a Sunitinib malate Sunitinib

U.S. FDA Resources

Further study details as provided by Kidney Cancer Research Bureau:

Primary Outcome Measures:

Progression-free survival [ Time Frame: 11 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
rate of complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
time from the end of ablation to start of medical treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
time to progression [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Quality of life (QOL) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	114
Study Start Date:	May 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1 38 patients	Procedure: Radiofrequency ablation; Interferon-alpha Patients undergo ablation by radiofrequency energy under CT-guidance. RFA continues until the entire tumor is treated. Treatment ceases when the entire lesion has undergone necrosis or the zone of necrosis or significant heat deposition approaches vital neurovascular structures. 38 patients will receive following immunotherapy with Interferon-alpha 9 MIU subcutaneously three times per week, 3 weeks on, 3 weeks off till progression. 38 patients will receive sunitinib maleate 50 mg orally once day, 28 days on, 14 days off till progression. Evaluation for response will be after second cycle.
Experimental: Arm 2 38 patients	Procedure: Radiofrequency ablation; Sunitinib maleate Patients undergo ablation by radiofrequency energy under CT-guidance. RFA continues until the entire tumor is treated. Treatment ceases when the entire lesion has undergone necrosis or the zone of necrosis or significant heat deposition approaches vital neurovascular structures. 38 patients will receive sunitinib maleate 50 mg orally once day, 28 days on, 14 days off, till progression. Evaluation for response will be after second cycle.
Experimental: Arm 3 38 patients	Drug: Sunitinib maleate 38 patients with unresected primary tumor will receive sunitinib maleate 50 mg orally once day, 28 days on, 14 days off, till progression. Evaluation for response will be after second cycle.

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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;

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891475

Contacts

Contact: Ilya Tsimafeyeu, MD

+79265646581

office@kidneytumor.org

Locations

Russian Federation
Ilya Tsimafeyeu	Recruiting
Moscow, Russian Federation, 109147
Contact: Ilya Tsimafeyeu

Sponsors and Collaborators

Kidney Cancer Research Bureau

Investigators

Study Director:	Ilya V. Tsimafeyeu, MD	KCRB
Principal Investigator:	Bin Chung, MD	Beijing Hospital

More Information

Additional Information:

KCRB

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Ilya Tsimafeyeu, Kidney Cancer Research Bureau
ClinicalTrials.gov Identifier:	NCT00891475 History of Changes
Other Study ID Numbers:	KCRB-003
Study First Received:	April 30, 2009
Last Updated:	September 18, 2010
Health Authority:	China: Ministry of Health

Keywords provided by Kidney Cancer Research Bureau:

metastatic renal cell carcinoma
radiofrequency ablation

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Interferon-alpha
Interferon Alfa-2a
Interferons

Sunitinib
Maleic acid
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2012