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Palliative Radiofrequency Ablation in Metastatic Renal Cell Carcinoma Patients

K

Kidney Cancer Research Bureau

Status and phase

Completed
Phase 2
Phase 1

Conditions

Carcinoma, Renal Cell

Treatments

Procedure: Radiofrequency ablation; Sunitinib maleate
Procedure: Radiofrequency ablation; Interferon-alpha
Drug: Sunitinib maleate

Study type

Interventional

Funder types

Other

Identifiers

NCT00891475
KCRB-003

Details and patient eligibility

About

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.

Full 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.

Enrollment

114 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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;

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

114 participants in 3 patient groups

Arm 1
Experimental group
Description:
38 patients
Treatment:
Procedure: Radiofrequency ablation; Interferon-alpha
Arm 2
Experimental group
Description:
38 patients
Treatment:
Procedure: Radiofrequency ablation; Sunitinib maleate
Arm 3
Experimental group
Description:
38 patients
Treatment:
Drug: Sunitinib maleate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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