Carcinoma, Renal Cell
Conditions
Keywords
metastatic renal cell carcinoma, radiofrequency ablation
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.
Interventions
PROCEDURERadiofrequency 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.
PROCEDURERadiofrequency 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.
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.
Sponsors
Kidney Cancer Research Bureau
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | 11 months |
Secondary
| Measure | 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 |
Countries
Russia
Outcome results
None listed