Palliative Radiofrequency Ablation in Metastatic Renal Cell Carcinoma Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Carcinoma, Renal Cell

Intervention / Treatment
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* Procedure: Radiofrequency ablation; Interferon-alpha
* Procedure: Radiofrequency ablation; Sunitinib maleate
* Drug: Sunitinib maleate


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>38 patients | Procedure: Radiofrequency ablation; Interferon-alpha<br>* 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.<br>|
| Experimental: Arm 2<br>38 patients | Procedure: Radiofrequency ablation; Sunitinib maleate<br>* 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.<br>|
| Experimental: Arm 3<br>38 patients | Drug: Sunitinib maleate<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 11 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic renal cell carcinoma, radiofrequency ablation