Palliative Radiofrequency Ablation in Metastatic Renal Cell Carcinoma Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kidney Cancer Research Bureau
ClinicalTrials.gov Identifier:
NCT00891475
First received: April 30, 2009
Last updated: February 11, 2014
Last verified: February 2014

April 30, 2009
February 11, 2014
May 2008
January 2010   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: 11 months ] [ Designated as safety issue: No ]
5-month progression-free survival [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00891475 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Progression-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Quality of life (QOL) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Progression-free survival [ Time Frame: 12 ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 1 year ] [ 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 ]
Not Provided
Not Provided
 
Palliative Radiofrequency Ablation in Metastatic Renal Cell Carcinoma Patients
Phase II Trial of Palliative Radiofrequency Ablation in Metastatic Renal Cell Carcinoma Patients With Small Primary Tumor

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Renal Cell
  • 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.
  • 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.
  • 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.
  • Experimental: Arm 1
    38 patients
    Intervention: Procedure: Radiofrequency ablation; Interferon-alpha
  • Experimental: Arm 2
    38 patients
    Intervention: Procedure: Radiofrequency ablation; Sunitinib maleate
  • Experimental: Arm 3
    38 patients
    Intervention: Drug: Sunitinib maleate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
114
January 2011
January 2010   (final data collection date for primary outcome measure)

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;
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT00891475
KCRB-003
Yes
Kidney Cancer Research Bureau
Kidney Cancer Research Bureau
Not Provided
Study Director: Ilya V. Tsimafeyeu, MD KCRB
Principal Investigator: Bin Chung, MD Beijing Hospital
Kidney Cancer Research Bureau
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP