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


Phase 1/Phase 2
18 Years
85 Years
Open (Enrolling)
Both
Carcinoma, Renal Cell

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Trial Information

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


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.


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;

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Time Frame:

11 months

Safety Issue:

No

Principal Investigator

Ilya V. Tsimafeyeu, MD

Investigator Role:

Study Director

Investigator Affiliation:

KCRB

Authority:

China: Ministry of Health

Study ID:

KCRB-003

NCT ID:

NCT00891475

Start Date:

May 2008

Completion Date:

January 2011

Related Keywords:

  • Carcinoma, Renal Cell
  • metastatic renal cell carcinoma
  • radiofrequency ablation
  • Carcinoma
  • Carcinoma, Renal Cell

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