Palliative Radiofrequency Ablation in Metastatic Renal Cell Carcinoma Patients

Carcinoma, Renal Cell Clinical Trial

Official title:

Phase II Trial of Palliative Radiofrequency Ablation in Metastatic Renal Cell Carcinoma Patients With Small Primary Tumor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00891475
• Other study ID #: KCRB-003
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 30, 2009
• Last updated: February 11, 2014
• Start date: May 2008
• Est. completion date: January 2011

Study information

• Verified date: February 2014
• Source: Kidney Cancer Research Bureau
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: January 2011
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

Intervention

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.
• 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.

Locations

Country	Name	City	State
Russian Federation	Ilya Tsimafeyeu	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Kidney Cancer Research Bureau

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		11 months	No
Secondary	Overall survival		24 months	No
Secondary	rate of complications		1 year	Yes
Secondary	time from the end of ablation to start of medical treatment		3 months	No
Secondary	Progression-free survival		6 months	No
Secondary	Quality of life (QOL)		6 months	Yes